Senior Pharmacovigilance Officer

Senior PV Officer Overview: We are a BioPharma company with 30 years in the UK, EU, and global markets, specializing in licensing, clinical development, and commercialization of medicines and devices to address unmet clinical needs.
Our mission is to improve patient lives and offer value to stakeholders through the development, licensing, and supply of medicines.

Role Summary: This global role involves overseeing pharmacovigilance (PV) and medical information (MI) support, serving as the main contact for PV and providing business MI support.

Key Responsibilities: Manage daily PV and MI mailboxes and maintain trackers.
Handle PV and MI reconciliation reports, review contracts, and manage adverse event (AE) reports.
Maintain UK/EU pharmacovigilance systems and Risk Management Plans.
Provide PV expertise and ensure compliance with UK PV legislation.
Conduct literature searches, oversee pharmacovigilance documents, and interact with health authorities when needed.
Collaborate with internal teams and international partners to maintain PV systems and ensure safety report accuracy.
Provide PV training and ensure adherence to standard operating procedures (SOPs).
Offer technical and medical information to Healthcare Professionals (HCPs) and Members of Parliament (MoPs) as required.
Prepare monthly metrics and manage MI inquiries and reports.
Required Skills/Experience: At least 5 years of PV experience, including involvement in audits/inspections.
Life science degree preferred.
Knowledge of MI inquiry handling and PV regulatory requirements (UK and EU).
Proficiency in Microsoft applications and strong communication skills.
Leadership skills with a focus on team building and motivation.
Strong interpersonal skills and ability to manage multiple priorities.