About the role
Summary
We 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.
Immunic Therapeutics is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status.
Please note, Immunic does not accept unsolicited resumes from external agencies or recruiters. Submission of a resume without a prior written agreement does not create any express or implied contract between Immunic and the agency. Immunic will not pay any fees related to unsolicited resumes.