Senior Pharmacovigilance Officer
Location: Hybrid, Surrey – 3 days pw onsite
The Company: A leading manufacturer of generic pharmaceutical products throughout the UK and Europe. Their mission is to better support people’s daily healthcare needs.
Job Purpose: We are seeking a dedicated Pharmacovigilance (PV) Officer to oversee PV activities across the UK and ROI. This role ensures full compliance with regulatory requirements, manages Safety Data Exchange Agreements (SDEAs), additional Risk Minimisation Measures (aRMMs), signal detection, and case management. The ideal candidate will maintain audit readiness, enhance PV processes, and drive cross-functional collaboration to uphold excellence in safety and regulatory standards. Additionally, you will support the Medical Information (MI) team in handling unsolicited enquiries in a compliant, objective, and transparent manner.
Main Accountabilities and Duties:
* Complete routine PV activities, including periodic reconciliations with business partners, Key Account Managers (KAMs), and UK Quality and MI.
* Manage the UK PV mailbox and action emails as appropriate.
* Ensure all PV cases are sent to Global Pharmacovigilance / Business Partners within timelines.
* Manage all UK Safety Data Exchange Agreements (SDEAs).
* Assist with the implementation of additional Risk Minimisation Measures (aRMMs) in the UK, including updates of RIMINI and other risk minimisation activities as required....