SummaryWe are seeking an accomplished Vice President of Global Drug Safety & Pharmacovigilance is an experienced healthcare professional (HCP) with expertise in good pharmacovigilance practices and international regulatory requirements (EMA/FDA/ICH). As the leader of the function, this individual is responsible for establishing and overseeing pharmacovigilance strategy & operations to ensure the safety of patients receiving company products.
Responsibilities- Develop and implement pharmacovigilance processes, policies, SOPs, and safety database/PV systems.
- Lead cross-functional governance, benefit-risk assessment, signal detection, and risk management efforts.
- Chair the executive safety review committee, oversee safety data exchange with partners, and contribute to industry-wide safety initiatives.
- Partner with clinical development to integrate safety into protocols, risk management plans, and safety charters.
- Provide PV oversight for regulatory filings (IND/BLA/MAA) - including Clinical Overviews, ISS, and RMPs - and review IBs, DSURs, and key CSR sections; participate in regulatory meetings as needed.
- Lead medical review of ICSRs and oversee PV team operations, quality, and compliance with global safety regulations.
- Monitor and assess CRO performance on pharmacovigilance activities.
- Recruit, hire, train, mentor, and coach PV staff, and oversee project deliverables and performance evaluations.
Qualifications & Education- MD, with clinical and industry experience and a proven track record leading pharmacovigilance teams.
- Minimum of 15 years' experience in drug safety and pharmacovigilance roles in the biotech or pharmaceutical industry.
- Proven leadership expertise, including a track record of building and leading high-performing teams.
- In-depth knowledge of global pharmacovigilance regulations and compliance requirements (EMA/FDA/ICH).
- Strong leadership and strategic decision-making abilities to drive safety initiatives and ensure regulatory compliance.
