Pharmacovigilance Services - Pharmafile Limited | Pharmaceutical Regulatory Affairs Consultants | IE

Pharmacovigilance Services – EU & UK (Human, Veterinary & Herbal Medicines; Cosmetovigilance)

Comprehensive drug safety and vigilance services covering human medicines, veterinary medicinal products, herbal medicinal products, and cosmetic products across Europe and the United Kingdom. We establish and maintain compliant pharmacovigilance systems for Marketing Authorisation Holders, including full EU and UK QPPV provision, adverse event case management, signal detection, periodic safety reporting, and cosmeto-vigilance support. The basis of the current EU regulations is that quality systems should form an integral part of the pharmacovigilance system to ensure effective monitoring of compliance and the accurate and proper documentation of all measures taken the ultimate objective being the protection of patients.

Our pharmacovigilance services are delivered through a structured model that can function as a turnkey solution or be tailored to fill specific gaps. The model spans the entire PV lifecycle from system setup before your product launches, through ongoing case handling and reporting, to signal analysis, periodic review, and inspection support.

Who This Service Is For

Marketing Authorisation Holders (MAHs) for prescription or over-the-counter human drugs, including small-to-mid-sized firms without a dedicated Drug Safety department. If you need to fulfil EU and UK pharmacovigilance obligations such as appointing a Qualified Person for Pharmacovigilance (QPPV) and maintaining a Pharmacovigilance System Master File but lack in-house resources, our service provides an immediate, inspection-ready solution. We support innovative products, generics, biosimilars, and traditional herbal medicinal products alike.

MAHs for veterinary medicinal products (for companion animals or food-producing animals) that must comply with EU veterinary pharmacovigilance requirements under Regulation (EU) 2019/6 and corresponding UK regulations. This includes vaccine manufacturers, animal health biotech firms, and established veterinary pharmaceutical companies seeking to outsource some or all pharmacovigilance tasks. Our internal pharmacovigilance SOPs reference the Veterinary Medicines Regulations 2013 (as amended) and Volume 9B, the Guidelines on Pharmacovigilance for Medicinal Products for Veterinary Use.

Companies holding registrations or authorisations for herbal medicinal products or traditional herbal remedies in the EU/UK. These products, while often perceived as low-risk, still carry pharmacovigilance obligations: adverse reactions must be monitored and reported, and periodic updates on safety may be required by authorities. We ensure even smaller herbal remedy producers can meet the same safety surveillance standards as conventional pharmaceutical companies.

Firms responsible for cosmetic products who need a cosmetovigilance system to monitor product safety in the market. Under EU Cosmetic Regulation (EC) No 1223/2009, in the event of serious undesirable effects, the responsible person and distributors shall without delay notify the competent authority of the Member State where the serious undesirable effect occurred. We offer cosmetovigilance support: establishing processes to capture adverse consumer reports, liaising with relevant assessors, and handling mandatory serious undesirable effect (SUE) notifications in the EU and UK.

Larger organisations with internal safety teams that occasionally need extra capacity or specialist support. Our team can undertake your whole pharmacovigilance requirements or alternatively perform any specific task where your company may have a temporary lack of resource due to increased workload or vacancies. We act as a flexible extension of your pharmacovigilance department.

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Our Pharmacovigilance Services Delivery Model

Regulatory Challenges We Address

Many companies struggle with the initial establishment of a pharmacovigilance system that meets EU and UK requirements. We help design and implement your PV system crafting Standard Operating Procedures, creating the Pharmacovigilance System Master File (PSMF), and integrating quality systems in line with regulatory expectations that quality systems should form an integral part of the pharmacovigilance system. This is crucial not only for compliance but also for demonstrating to inspectors that you take product safety seriously from launch onward.

By law, every MAH in the EU must have a single QPPV residing in the EEA, responsible for overall pharmacovigilance. The UK requires its own QPPV or national PV contact post-Brexit. Sourcing an appropriately qualified, experienced QPPV and a Deputy QPPV for backup can be difficult for smaller companies or those based outside Europe. We provide EU QPPV services (and UK QPPV or local contact, as needed). Our QPPV contractual arrangements specify that the QPPV will provide services and comply with responsibilities as set out in the relevant schedules, operating in accordance with relevant GVP modules and Pharmafile PV Standard Operating Procedures.

Whether it is a single spontaneous adverse drug reaction (ADR) from a patient or a cluster of product complaints, companies must capture, assess, and report these events within strict timelines. We offer collection and follow-up of spontaneous adverse drug reactions (ADRs) received on behalf of the Marketing Authorisation Holder, electronic management of ADRs, and expedited reporting to Health Authorities. We tackle the challenge of 24/7 case intake, medical evaluation, and regulatory submission, ensuring no case is missed and all deadlines are met.

Modern pharmacovigilance requires proactive signal management detecting patterns that could indicate a new risk or a change in a product’s benefit-risk profile. We provide signal detection services and Risk Management Plans (RMPs) as part of our core offerings. We implement a scaled approach to signal detection (routine database screening, literature monitoring, trending of ADRs) and provide expert analysis on whether a signal warrants further action.

Keeping up with Periodic Safety Update Report (PSUR/PBRER) schedules and content can be daunting, especially if you have multiple products each on different reporting cycles. Our pharmacovigilance team is responsible for preparation, review, and reporting/submission of Periodic Safety Update Reports (PSURs) as described within our established SOPs, with the QPPV ensuring medical assessment of PSURs takes place where applicable. For veterinary medicines, we manage Periodic Safety Update Reports as required under the applicable legislation, including the Veterinary Medicines Regulations 2013 and Volume 9B guidelines.

Since Brexit, EU and UK safety reporting have diverged. Companies now often need to submit cases and PSURs to both the EMA (and national EU agencies) and the UK’s MHRA separately. Our PSUR SOPs explicitly reference both EU GVP Module VII Periodic Safety Update Reports (available from the EMA) and the MHRA Good Pharmacovigilance Practices (GVP) Guidelines. We manage dual submissions to ensure nothing falls between the cracks.

Pharmacovigilance inspections by EMA, national agencies (HPRA, MHRA, etc.), or the FDA can occur with limited notice. We conduct pre-inspection audits to identify compliance gaps and help you fix them before the regulators arrive. If you have already been inspected and received a critical finding, we can step in to help execute the Corrective and Preventive Action (CAPA) plan, bringing your system back into compliance.

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What Regulators Expect

In both the EU and UK, regulatory authorities have clear expectations for pharmacovigilance systems. A marketing authorisation is granted on the condition that you will monitor and ensure the ongoing safety of your product. The following outlines the core requirements:

A Functional Pharmacovigilance System with Quality Oversight

EU legislation (Regulation (EC) No 1235/2010 and Directive 2010/84/EU, underpinned by the EC Implementing Measures Regulation No 520/2012) and the supporting Good Pharmacovigilance Practices (GVP) a series of 16 modules developed by the EMA require every MAH to establish and maintain an effective PV system. The basis of these regulations is that quality systems should form an integral part of the pharmacovigilance system to ensure effective monitoring of compliance and the accurate and proper documentation of all measures taken. This includes a Pharmacovigilance System Master File (PSMF) that describes your PV system and is kept up-to-date, and a robust set of standard operating procedures. In an inspection, you must demonstrate that you document all measures taken in your PV system and regularly monitor compliance.

Qualified Personnel (QPPV) and Continuous Availability

Authorities mandate that a Qualified Person for Pharmacovigilance (QPPV) is in place at all times for human and veterinary medicinal products. The QPPV is responsible for the establishment and maintenance of the PV system and must reside within the EU/EEA for EU-authorised products. For the UK, post-Brexit regulations require a UK QPPV who resides and operates in the UK. Our QPPV agreements specify that the legal responsibility remains with the Pharmafile PV Service QPPV, and that the Deputy (Stand-In) QPPV is kept up to date on all pharmacovigilance activities relating to all necessary information to enable the Deputy to stand in at any given time. The QPPV is expected to have sufficient authority within your company to effect change. During inspections, QPPVs are often interviewed in depth; they should be fully knowledgeable about all products’ safety profiles, ongoing safety issues, and the content of the PSMF.

Timely Adverse Event Reporting

It is a non-negotiable regulatory expectation that all adverse reactions are reported within prescribed timelines. For human medicines, serious ADRs must be submitted to EudraVigilance within the legally mandated expedited timeframe, and non-serious ADRs within the applicable standard timeframe. Similar timelines apply in the UK via the MHRA’s reporting systems. For veterinary medicines, serious adverse events must be reported to the relevant pharmacovigilance database and national authority within the applicable expedited timeframe. Cosmetics have a different but analogous expectation — if a cosmetic product causes a Serious Undesirable Effect, in the event of serious undesirable effects, the responsible person and distributors shall without delay notify the competent authority of the Member State where the serious undesirable effect occurred, reporting all serious undesirable effects which are known or which may reasonably be expected to be known, the name of the cosmetic product concerned enabling its specific identification, and the corrective measures taken. Failure to report on time is one of the most common and serious inspection findings.

Continuous Benefit-Risk Evaluation and Signal Management

MAHs are expected to continually evaluate the balance of benefits and risks of their products. This expectation is formalised via Periodic Safety Update Reports (PSURs). Each PSUR must provide a scientific analysis of whether new information impacts the product’s benefit-risk profile. In the veterinary arena, Regulation (EU) 2019/6 similarly requires submission of PSURs at intervals determined by a reference date list or as specified in the marketing authorisation. Besides scheduled reports, authorities require that MAHs operate a signal detection system. For human medicines, GVP Module IX outlines that MAHs must have a process to identify and prioritise signals and notify authorities of new important safety findings.

Risk Management and Risk Minimisation

When a product is approved, it likely comes with an RMP (Risk Management Plan) outlining known safety concerns and mitigation strategies. Regulators expect you to implement the commitments in your RMP. If additional Risk Minimisation Measures (RMMs) were imposed, regulators will check that these measures are being carried out effectively.

Regulatory Authority Engagement and Responsiveness

Authorities expect MAHs to be responsive and cooperative. This includes answering safety queries promptly and being prepared for pharmacovigilance inspections. The Regulatory Affairs department is responsible for providing support and the required information to the Pharmacovigilance department with respect to the various Marketing Authorisations.

Special Case — Pharmacovigilance for Different Product Types

Herbal Medicinal Products: In the EU, these are regulated either as well-established use medicines or under Traditional Herbal Registrations. Even if a product has a “traditional use” registration, pharmacovigilance still fully applies. Authorities expect you to collect and report adverse reactions for herbal medicines, even if they contain ingredients used for centuries.
Cosmetics (Cosmetovigilance): Under Article 23 of EU Regulation (EC) No 1223/2009, any Serious Undesirable Effect (SUE) must be reported to the national authority where it happened. Where the responsible person reports serious undesirable effects to the competent authority of the Member State where the effect occurred, that competent authority shall immediately transmit the information to the competent authorities of the other Member States.

Maintaining MAH Oversight

A final overarching expectation: the MAH retains ultimate responsibility for pharmacovigilance. Even if you outsource activities, you as the MAH must supervise and ensure those activities are compliant. Inspectors will often ask for evidence of how the MAH oversees its PV service provider.

QPPV / Deputy QPPV Provision & Oversight

PV System Set-Up & Governance

When you onboard with us, we first establish a pharmacovigilance system that meets all regulatory requirements and fits your company’s size and product profile:

Creating or updating your Pharmacovigilance System Master File (PSMF) a living document that describes your PV processes, safety database, QPPV details, and interfaces. The PSMF structure typically covers: Change Control Sheet; Qualified Person for Pharmacovigilance (statement, contact details, CV, job description); Organisation (names and addresses of organisations and locations where pharmacovigilance activities are undertaken, contact details for local PV departments, identification of the EU location where PV data are accessible, organisation chart and summary of PV activities); Flow diagrams indicating the flow of safety reports of different origins (including post-marketing and clinical trial AE reports); Archiving of PV documentation; Responsibilities for auditing of the PV system; Exchange and handling of safety information between the MAH and business partners; List of PV procedures in place; and Global safety database details.
Developing necessary Standard Operating Procedures (SOPs) and governance documents. We either provide you with our templated SOPs (which you can adapt and own) or operate under our internal SOPs, depending on regulatory preference and your choice. In either case, everything is documented and maintained under version control.
Setting up the safety database / ADR management tool. We employ a validated electronic database for managing Individual Case Safety Reports (ICSRs) this ensures every adverse event is logged, evaluated, and tracked through to submission.
Establishing intake channels including dedicated email addresses and, if needed, phone/fax lines for adverse event reports. We also advise on and help implement any necessary language on your product literature and website about how healthcare professionals or patients can report adverse reactions.
Governance structure: We form a Safety Management Team or committee for your product(s). We schedule regular meetings to formally discuss safety data, ensuring management oversight. Minutes of these meetings serve as documentation of MAH oversight and are very useful during inspections.

Case Management & Reporting (ICSRs)

At the heart of pharmacovigilance is the handling of Individual Case Safety Reports (ICSRs). We manage this entire process:

We receive adverse event reports through various sources: medical information queries, emails or phone calls from healthcare providers, patient complaints, partner companies via contractual agreements, and routine literature surveillance. Our pharmacovigilance specialists immediately log reports in the safety database.

Each case is reviewed by a trained drug safety physician or pharmacist. They perform causality assessment and code the case using MedDRA terminology.

If more information could significantly clarify the case, we perform follow-up with the reporter, crafting medically pertinent questions. All follow-up attempts are documented.

We conduct routine literature searching to identify potential adverse events related to the Marketing Authorisation Holder’s products. This means at least weekly screening of international databases for your product’s active substance, plus local journals if necessary (especially for herbal or traditional products).

Based on the case data and applicable rules, we handle expedited reporting to Health Authorities. For the EU, this means electronic submission of ICSRs to EudraVigilance; for the UK, we submit to the MHRA’s systems. We have the technical capability and regulatory registrations to do this.

Once an ICSR is reported, we document it comprehensively. All source documents are stored and linked to the case in the event they are needed during inspections or in response to authority queries.

Our case processing services cover all types of safety reports: spontaneous reports, reports from post-authorisation studies or patient support programmes, medication error reports, lack of efficacy (particularly critical in veterinary or vaccine pharmacovigilance), off-label use, misuse, and abuse cases, and product quality complaints with adverse events.

Periodic Safety Reporting & Regulatory Submissions

We handle all aggregate safety reports and related regulatory submissions:

Periodic Safety Update Reports (PSURs/PBRERs): Our pharmacovigilance team is responsible for preparation, review and reporting/submission of Periodic Safety Update Reports (PSURs) as described within our SOPs. The QPPV is responsible for overseeing the processes and procedures, including ensuring medical assessment of PSURs takes place where applicable. We handle electronic submission to the EMA’s PSUR Repository for the EU and directly to the MHRA or national authorities for the UK.

Periodic reports for veterinary medicines: Our SOPs reference the Veterinary Medicines Regulations 2013 (as amended) and Volume 9B, the Guidelines on Pharmacovigilance for Medicinal Products for Veterinary Use. We prepare veterinary PSURs with the specific veterinary focus including calculation of reporting rates per species, analysis of lack of expected efficacy reports, etc.

Regulatory submissions for safety variations: When a PSUR or signal assessment outcome requires product information updates, we prepare the variation dossier: revised label texts, clinical overview or justification for the change, and application forms. Through our Regulatory Affairs service or in collaboration with your RA department, we then submit to authorities.

Safety Communications: When necessary, we draft Direct Healthcare Professional Communications (DHPCs), Dear Doctor Letters, Fact Sheets, or FAQs. We manage the approval process of these communications with regulators and coordinate dissemination.

PSUR preparation references: Our processes are aligned with Guideline on good Pharmacovigilance practices (GVP) Module VII Periodic safety update reports (available from the EMA), the EMA Explanatory Note to GVP Module VII, and the MHRA Guidance Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK MAHs, as well as the MHRA Good Pharmacovigilance Practices (GVP) Guidelines.

Inspections, Audits & Ongoing PV Management

We treat compliance metrics as a key performance indicator, including case reporting timeliness, follow-up rates, and PSUR submission timeliness. We maintain these metrics and review them with you quarterly.

As part of our quality system, we periodically audit our own processes. The PSMF structure includes documented responsibilities for auditing of the PV system.

When you receive a notice of a pharmacovigilance inspection, we help prepare inspection briefs, compile all required documents, conduct mock interviews with your personnel, and make our QPPV and relevant team members available on-site or remotely.

The PV landscape evolves new GVP modules or revisions emerge, new electronic systems are introduced. Because we serve multiple clients, we stay ahead of these changes and update your processes accordingly.

Some clients engage us on a retainer basis where we handle all PV continuously. Others use us as backup or additional support for example, weekend coverage, or emergency signal evaluation. We can scale our level of service up or down as your needs change.

Our PV service does not operate in isolation. Our corporate structure includes regulatory affairs consultancy (through Pharmafile Limited) and pharmacovigilance services (through Pharmafile PV Services Limited), both located in Ireland, with an associated company SEQ Limited located in the Isle of Man. This integrated structure means PV, RA, and quality functions can communicate and collaborate efficiently.

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Jurisdictions Covered

We cover EU pharmacovigilance obligations EU-wide. A single QPPV and PSMF covers all your EEA authorisations. We manage reporting to the central EMA systems (EudraVigilance for human medicines, and the Union Pharmacovigilance Database for veterinary medicines) as well as any necessary supplemental national reporting. Our PSMF structure includes identification of the location in the European Union where pharmacovigilance data are accessible.

We handle separate UK pharmacovigilance post-Brexit. We ensure your product has a UK-based QPPV and that UK-specific reporting requirements are met. We submit all ICSRs to the MHRA’s systems. Our PSUR SOPs reference the MHRA Good Pharmacovigilance Practices (GVP) Guidelines and the guidance on exceptions and modifications to the EU GVP that apply to UK MAHs and the MHRA.

For veterinary products, we handle reporting in accordance with the Veterinary Medicines Regulations 2013 (as amended) and Volume 9B guidelines. Under the new EU system (Regulation 2019/6), veterinary ICSRs and PSURs are managed through the Union Product Database. For the UK’s VMD, we submit veterinary ADRs via the VMD’s reporting scheme.

EU law is harmonised by Regulation (EC) No 1223/2009, but enforcement is at the national level. If a serious undesirable effect occurs, we notify the relevant country’s authority as required. Where the responsible person reports serious undesirable effects to the competent authority of the Member State where the effect occurred, that competent authority shall immediately transmit the information to the competent authorities of the other Member States. For the UK, cosmetovigilance is governed by the UK Cosmetic Products Enforcement Regulations.

While our focus is EU/UK, we frequently coordinate with global PV through Safety Data Exchange Agreements, ensuring no data falls through gaps between jurisdictions.

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Typical Timelines

Pharmacovigilance is a continuous process with varied timelines for different activities. The following summarises typical timeframes associated with key pharmacovigilance tasks and regulatory requirements. These are indicative and assume standard conditions; exact timelines can vary based on agency responsiveness and specific product circumstances.

Activity / Requirement	Timeline or Frequency	Notes
Initial PV System Setup (Pre-Launch)	~4–8 weeks (one-time setup)	From engagement to having QPPV in place, PSMF ready, SOPs approved, and database configured. Engage at least 2 months before product launch.
Adverse Event Case Processing	Per applicable regulatory timeframes (human & veterinary)	Urgent cases (e.g. fatalities) are accelerated.
Regulatory Reporting of Serious ICSRs	Expedited per applicable regulatory timeframes (human & veterinary)	Specific day-count requirements are defined by the applicable legislation and GVP modules. The MHRA applies equivalent expectations for UK products.
Literature Search Frequency	Weekly (for high-risk/multiple products); Monthly (for low-volume products)	Literature cases are treated from date of publication awareness.
Signal Detection Reviews	Monthly (products with large exposure and data); Quarterly (most other products)	Documentation is completed within a week of each review.
PSUR (PBRER) Reporting (Human	Frequency per the EU Reference Dates (EURD) list typically more frequent for newer products, less frequent for established ones	Each PSUR is due within the timeframe specified by the EURD list after data lock point.
Veterinary PSUR	As per applicable legislation and Union reference dates	Under Regulation (EU) 2019/6, routine PSURs for well-established vet products may not be required annually.
Safety Variation Implementation	As per applicable legislation and Union reference dates	Urgent safety changes can be handled as Urgent Safety Restrictions in days, with formal variation to follow.
Pharmacovigilance Inspection Cycle	As per applicable legislation and Union reference dates	We ensure continuous inspection-readiness regardless of cycle.
Cosmetovigilance Serious Incident Handling	Immediate action; notify authorities without delay	Investigation of cause is initiated immediately.
Monthly/Quarterly Client Reports	Delivered within 10 days of period end	Safety summary reports for MAH oversight.
PV System & SOP Updates	Live-tracked; major review annually	PSMF is a live document. SOPs reviewed on a defined cycle or immediately when regulations change.

(The above timelines are for typical scenarios. In urgent public health situations, processes can accelerate significantly. Specific regulatory reporting day-counts should be confirmed against current applicable legislation and GVP guidance.)

Common Mistakes We Help You Avoid

One of the most critical failures is when an MAH does not report an adverse event because it was never forwarded internally for example, a patient calling a customer service line to complain about a side effect, and the untrained customer service staff failing to forward it. We establish intake training and procedures across your company so that everyone from sales representatives to call centre staff is briefed to forward anything that sounds like an adverse effect immediately.

Perhaps the most common inspection finding is late ICSR submission. With our robust case processing and tracking, we load-balance resources in real time; if a surge of cases comes in, we bring in additional case processors rather than allow a backlog to form. Our database has built-in clocks and alerts well before deadlines.

Another pitfall is submitting cases with poor quality or not attempting follow-up. We make reasonable follow-up attempts on every case where pertinent information is missing. All attempts are documented, so even if information cannot be obtained, we have proof of effort.

We frequently see companies focus on spontaneous reports but forget literature monitoring. Our service includes comprehensive routine literature searching to identify potential adverse events related to the Marketing Authorisation Holder’s products, ensuring published case reports or safety concerns are captured.

If your RMP says you will conduct a specific study or distribute educational materials, failing to do so is a mistake regulators view harshly. We maintain a tracker of all Pharmacovigilance Plan and Risk Minimisation measures and ensure they are carried out on schedule.

“If it’s not documented, it didn’t happen” this is a mantra in PV inspections. Our system is documentation-heavy by design. Every case has a record, every meeting has minutes, the PSMF is updated with a change log, and every QPPV oversight activity is logged.

Safety issues often cross over with quality (e.g., product defects causing ADRs) or clinical functions. We foster cross-functional connections: the Regulatory Affairs department is responsible for providing support and the required information to the Pharmacovigilance department with respect to the various Marketing Authorisations.

Companies with primarily cosmetics or supplements sometimes think PV is only for medicines. Under Regulation (EC) No 1223/2009, serious undesirable effects from cosmetics must be reported without delay to the relevant competent authority. We implement right-sized vigilance for all product types you have.

PV regulations and guidance’s do change for instance, after the 2012 EU legislation (Regulation No 1235/2010 and Directive 2010/84/EU, underpinned by Implementing Measures Regulation No 520/2012) some companies were slow to implement the required changes. More recently, Brexit and new veterinary legislation changed reporting routes. We mitigate this by staying ahead of regulatory changes and updating your processes accordingly.

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Q & A

Q1. What is pharmacovigilance and why do we need it?

Pharmacovigilance is the practice of monitoring the safety of medicines and taking action to reduce risks and increase benefits. It involves collecting and evaluating information from healthcare providers, patients, and scientific studies to detect any adverse effects or other drug-related problems. The ultimate objective is the protection of patients. Good pharmacovigilance is also a legal requirement for marketing a drug: authorities will only allow a product to stay on the market if its benefits outweigh its risks, and pharmacovigilance is how that balance is confirmed over time.

Q2. Does pharmacovigilance apply to veterinary and herbal medicines too?

Yes. Veterinary medicinal products have their own pharmacovigilance systems the EU implemented a modernised veterinary PV framework under Regulation (EU) 2019/6, and the UK follows the Veterinary Medicines Regulations 2013 (as amended), with additional guidance in Volume 9B. Herbal medicines, though often perceived as “natural”, can cause adverse reactions or interact with other drugs, and regulators expect companies to monitor and report those just as with any medicine. Even for non-medicines like cosmetics, there is “cosmetovigilance” for serious adverse effects under Regulation (EC) No 1223/2009.

Q3. What is the role of a QPPV and do I need one?

The Qualified Person for Pharmacovigilance (QPPV) is a regulatory requirement in the EU (and similarly in the UK) for any company holding a medicine’s marketing authorisation. We aim to provide a comprehensive PV service, including a QPPV, which can be tailored to suit individual companies’ needs. The QPPV is the designated person responsible for the overall pharmacovigilance system and the safety of all the company’s medicinal products, ensuring adverse events are reported on time, PSURs are submitted, safety concerns are acted upon, and the PSMF is kept up to date. If you do not have an appropriately qualified person in-house, you must appoint one or contract the responsibility to a provider.

Q4. What is a Pharmacovigilance System Master File (PSMF)?

The PSMF is a comprehensive document that describes your company’s pharmacovigilance system. It includes details such as who your QPPV is and how to contact them; what systems you use for case collection; how you manage and train personnel; performance metrics; lists of all your products; and any partners sharing PV responsibilities. The PSMF must reflect the current state of your PV system. The typical PSMF covers: the Qualified Person for Pharmacovigilance section; Organisation (including names and addresses of organisations where PV activities are undertaken); flow diagrams indicating the flow of safety reports of different origins; archiving of PV documentation; responsibilities for auditing the PV system; exchange and handling of safety information with business partners; list of PV procedures in place; and global safety database details.

Q5. How quickly do adverse events have to be reported to regulators?

The speed of reporting depends on the severity of the case and the applicable legislation. For serious adverse drug reactions, expedited reporting within the legally mandated timeframe is required. For non-serious cases, a longer standard timeframe applies. For cosmetics, serious undesirable effects must be reported without delay to the competent authority of the Member State where the effect occurred. These are legal requirements. In practice, aim to submit reports as soon as possible rather than waiting until the deadline.

Q6. What counts as an adverse event that needs to be reported?

An adverse event is any undesirable medical occurrence in a patient or clinical trial subject after exposure to a medicine, whether or not it is confirmed to be caused by the medicine. The scope includes known or unknown side effects; lack of effect; overdose; misuse; abuse; medication error if an adverse outcome results or could result; and occupational exposure. For pharmacovigilance reporting, you need at minimum: an identifiable patient (or animal), an identifiable reporter, a suspected drug, and an event. When in doubt, report it.

Q7. If a patient overdoses on our drug or uses it incorrectly, do we report that?

Yes, if there is an adverse outcome or potential for harm. Overdose and misuse are within the scope of pharmacovigilance. Cases of overdose, medication error, off-label use, abuse, or misuse that result in an adverse reaction must be reported. Even if no adverse reaction occurs, significant overdoses or errors may still need to be reported under certain regulatory frameworks.

Q8. What is a PSUR and who needs to submit it?

A PSUR (Periodic Safety Update Report, also called PBRER Periodic Benefit-Risk Evaluation Report) is a comprehensive report that MAHs submit at regular intervals to update the product’s safety profile. Our pharmacovigilance team is responsible for preparation, review and reporting/submission of PSURs, PSUR-related reports and Benefit-risk reports for authorised products. The QPPV is responsible for overseeing these processes and for ensuring medical assessment of PSURs takes place where applicable.

Q9. How are safety signals detected and managed?

We provide signal detection as part of our core service offering. Signal management involves: detection (using quantitative methods such as disproportionality analysis and qualitative medical review of case series); validation/prioritisation (assessing whether the signal is based on reliable data and could represent a new risk); analysis and assessment (determining frequency, possible mechanism, and comparison to background rates); action (regulatory notification if significant, product information updates, or further data collection); and communication (through DHPCs or bulletins if needed).

Q10. What is a Risk Management Plan (RMP)?

A Risk Management Plan is a document required for most new medicines that outlines the known important risks and what will be done to further characterise and mitigate those risks. We prepare and maintain Risk Management Plans as part of our services. An RMP has several parts: Safety Specification (what is known and not known about safety); Pharmacovigilance Plan (activities to learn more about safety); and Risk Minimisation Plan (measures to prevent or reduce risks). The RMP must be kept current and updated if a new significant risk is identified.

Q11. How does pharmacovigilance differ for cosmetics (cosmetovigilance)?

Cosmetovigilance is the post-market surveillance of cosmetics’ safety. It is conceptually similar to pharmacovigilance but less formalised. There is no requirement for a QPPV or PSMF for cosmetics. Instead, Regulation (EC) No 1223/2009 requires that each cosmetic product has a Responsible Person who must collect data on undesirable effects (UEs) and serious undesirable effects (SUEs). If a SUE occurs, in the event of serious undesirable effects, the responsible person and distributors shall without delay notify the competent authority of the Member State where the serious undesirable effect occurred, reporting all serious undesirable effects known or which may reasonably be expected to be known, the name of the cosmetic product concerned enabling its specific identification, and the corrective measures taken.

Q12. How do you ensure compliance with both EU and UK pharmacovigilance post-Brexit?

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Related Services & Resources

To support a comprehensive solution, we integrate pharmacovigilance services with other key offerings:

Regulatory Affairs Management (Human & Veterinary) – Our end-to-end regulatory affairs service covers the submission and maintenance of Marketing Authorisations in the EU and UK. This ties in closely with pharmacovigilance: when a safety signal necessitates a label change, our Regulatory Affairs team can prepare and file the variation promptly.
Quality & Compliance Services – Quality Assurance consulting (including GDP/GMP compliance, audits) complements pharmacovigilance because sometimes quality defects lead to safety issues. Quality and PV should collaborate when handling product quality complaints that involve a health issue.
eCTD & Electronic Submission Support – Through our eCTD publishing services, we manage electronic Common Technical Document submissions for variations and renewals. For PV, this is relevant when submitting PSURs or safety variations.
Regulatory Outsourcing – For companies needing to delegate specific tasks or fill temporary resource gaps, we provide flexible outsourcing arrangements. Our team is able to undertake your whole pharmacovigilance requirements or alternatively perform any specific task where your company may have a temporary lack of resource due to increased workload or vacancies.
Knowledge Centre – We publish explanatory articles and briefings on regulatory and pharmacovigilance topics to help clients stay informed of developments that may affect their products.