Pharmacovigilance Manager
Company: Morgan Prestwich - Global Biotech, MedTech & CDMO Recruitment Agency
- Location: Surrey, United Kingdom
- Seniority: Senior
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
PV Partner Manager is responsible for managing PV relationships with external partners and licensors. This role ensures partnerships are supported by robust safety agreements and maintains clear oversight of safety activities across partner markets, while leading the onboarding of new partners into the organisation’s pharmacovigilance framework.
Role spec:
Coordinate the negotiation and maintenance of Pharmacovigilance Agreements (PVAs), ensuring they are in place ahead of Marketing Authorisation Transfer (MAT).Act as the primary PV contact for partners, maintaining oversight of PV requirements and activities across partner markets.Coordinate partner safety signal management, including identification, assessment, escalation and communication.Monitor safety variation requirements and ensure label changes, submissions and related change control activities are completed on time.Manage aggregate safety reporting obligations for partner products, including submission requirements and timelines.Coordinate PV set-up for Patient Support Programmes (PSPs), including PV training and PVA development.Work with the PV vendor to ensure new partners and PVA requirements are accurately captured within the PV system.Support updates to the MAH Oversight Procedure, relevant SOPs and the PSMF.Maintain accurate records of PV agreements, oversight activities and safety commitments, reporting progress to the VP of Pharmacovigilance.Support a compliant, inspection-ready PV system, including change control and deviation management within the QMS.Ensure ongoing GxP compliance by adhering to applicable regulations, SOPs and approved documentation.
Desired:
Degree in Life Sciences, Pharmacy or a related field, or equivalent professional experience.Strong pharmacovigilance experience, ideally covering partner/vendor oversight, PVA negotiation or M&A safety integration.Working knowledge of aggregate safety reporting, signal management and safety variation requirements.Experience working with outsourced PV models is advantageous.Knowledge of PV legislation outside the UK and EU is advantageous.Strong relationship management skills, with confidence representing PV externally to partners and vendors.Highly organised, able to manage multiple agreements, activities and deadlines simultaneously.Clear communicator who can translate PV requirements into practical partner-facing solutions.Agile and adaptable, with the ability to work effectively in a fast-changing environment.Strong problem-solving skills and the ability to navigate complex issues.Growth mindset with a willingness to learn and develop.High integrity and strong ethical standards.Collaborative team player who respects different perspectives and works towards shared goals.Results-driven, accountable and focused on delivering outcomes.
