Pharmacovigilance (PV) Team Leader – Role Overview
This role acts as the Pharmacovigilance lead for the Marketing Authorisation Holder (MAH), ensuring all UK and EU pharmacovigilance obligations are met throughout the product lifecycle. The position provides operational and compliance oversight of outsourced pharmacovigilance service providers and ensures activities are delivered in line with EU GVP, UK legislation, MHRA requirements, and internal procedures.
The PV Team Leader represents the MAH on day-to-day pharmacovigilance matters and works closely with the QPPV and UK QPPV to maintain effective oversight of the PV system. This includes maintaining pharmacovigilance agreements with partners, distributors, and vendors, and ensuring ongoing compliance across all products.
A key part of the role is the oversight of outsourced PV providers. This includes monitoring performance against KPIs and SLAs, reviewing and approving PV deliverables, leading regular governance meetings, and ensuring any issues, deviations, or CAPAs are identified, managed, and closed appropriately.
The role also oversees safety case management and regulatory reporting activities. This includes ensuring accurate and timely ICSR reporting to EudraVigilance, MHRA, and other relevant authorities, as well as overseeing case validation, medical review, and submission timelines to meet UK and EU reporting requirements.
In addition, the PV Team Leader oversees aggregate safety reporting and risk management activities, including PSURs, PBRERs, Risk Management Plans, and signal management documentation. They ensure safety signals are detected, evaluated, escalated appropriately, and contribute to benefit-risk assessments and safety communications where required.
From a quality and compliance perspective, the role maintains the MAH pharmacovigilance quality management system, ensures PV SOPs remain current and effective, and supports PV inspections and audits conducted by the MHRA, EMA, partners, or internal audit teams. This includes maintaining inspection readiness, managing responses, and overseeing CAPA activities, as well as ensuring PV training requirements are completed and documented.
The role works cross-functionally with Regulatory Affairs, Quality, and Commercial teams, providing pharmacovigilance input into regulatory submissions and variations. It also ensures that safety information is accurately reflected in product information such as SmPCs and PILs, while supporting continuous improvement of pharmacovigilance systems and processes
:quality(80))
:quality(80))
:quality(80))