Senior Pharmacovigilance Specialist — UK

Myn; Greater London; On-site; GBP 45,000 - 65,000; Full time

Job summary

Myn is seeking a Pharmacovigilance professional to support end-to-end PV processes, including adverse event intake, processing, signal management and regulatory reporting. The role requires strong attention to detail and a solid grounding in drug safety and MHRA requirements.

The successful candidate will liaise with QA, medical affairs and regulatory teams, ensure submissions align with regulatory timelines, and contribute to audits and inspections to maintain compliant PV operations.

Qualifications

• Bachelor's degree in life sciences, pharmacy, nursing, or related healthcare field.
• Demonstrable experience in pharmacovigilance/drug safety, preferably in pharma, CRO, or PV service provider under MHRA oversight.
• Working knowledge of MedDRA coding and case processing in a safety database.
• Solid understanding of UK pharmacovigilance legislation and MHRA GVP guidance.
• Excellent written and verbal communication with strong attention to regulatory timelines.

Responsibilities

• Receive, triage, and process AE/ADR reports from multiple sources.
• Data entry, MedDRA coding, quality review of ICSRs in safety database.
• Ensure timely submission of expedited and periodic safety reports.
• Support signal detection, PSURs/PBRERs, and risk management plans.

Skills

Pharmacovigilance experience

MedDRA coding

Regulatory reporting & timelines

UK MHRA/GVP knowledge

Excellent written and verbal comms

I CSR case data review

Education

Life sciences/pharmacy/nursing degree

Tools

ArisG

ArgusSafety

Job description

Role Overview

The successful candidate will support the end-to-end pharmacovigilance process, from adverse event case receipt and processing through to signal management and regulatory reporting, ensuring compliance with MHRA (Medicines and Healthcare products Regulatory Agency) requirements and applicable pharmacovigilance legislation. This role suits a life sciences or healthcare professional with strong attention to detail and a solid understanding of drug safety principles.

Key Responsibilities

• Receive, triage, and process adverse event (AE) and adverse drug reaction (ADR) reports from all sources (spontaneous, clinical trial, literature, and solicited).
• Perform case data entry, medical coding (MedDRA), and quality review of individual case safety reports (ICSRs) in the company's safety database.
• Ensure timely submission of expedited and periodic safety reports in line with regulatory timelines.
• Support signal detection and evaluation activities, contributing to periodic safety update reports (PSURs/PBRERs) and risk management plans (RMPs).
• Submit ICSRs and aggregate reports via the MHRA's ICSR submission gateway and, where applicable, the Yellow Card scheme as required.
• Assist with literature surveillance, screening relevant publications for potential safety information.
• Support PV audits and inspections, maintaining audit-ready documentation and case files at all times.
• Liaise with regulatory affairs, clinical operations, medical information, and quality teams on safety-related matters.
• Contribute to the maintenance and continuous improvement of PV standard operating procedures (SOPs).
• Support training of internal stakeholders and partners on pharmacovigilance reporting obligations.

Essential Qualifications & Experience

• Life sciences, pharmacy, nursing, or related healthcare degree.
• Demonstrable experience in a pharmacovigilance/drug safety role, ideally within a pharmaceutical company, CRO, or PV service provider operating under MHRA (Medicines and Healthcare products Regulatory Agency) oversight.
• Working knowledge of MedDRA coding and case processing in a recognised safety database (e.g. ArisG, ArgusSafety, or similar).
• Solid understanding of UK pharmacovigilance legislation (Human Medicines Regulations 2012, as amended) and MHRA Good Pharmacovigilance Practice (GVP) guidance.
• Excellent written and verbal communication skills, with strong attention to detail and accuracy under regulatory timelines.

Desirable Criteria

• Experience supporting signal detection, PSUR/PBRER, or RMP preparation.
• Prior involvement in PV audits or regulatory inspections.
• Experience working within a QPPV/deputy QPPV support structure.
• Postgraduate qualification in pharmacovigilance, pharmacoepidemiology, or a related discipline.
• Experience with vendor/partner oversight for outsourced PV activities.

Person Specification

• Meticulous attention to detail, particularly in case data accuracy and regulatory reporting timelines.
• Strong organisational skills, able to manage competing case processing deadlines.
• Comfortable working within a highly regulated, audit-driven environment.
• Collaborative team player, able to liaise effectively across regulatory, clinical, and quality functions.
• Proactive approach to identifying and escalating potential safety signals or compliance risks.