Vice President, Pharmacovigilance
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Immunic TherapeuticsBiotechnology, Pharmaceuticals
Remote - USFull-TimeVp
Salary$330K - $410K; $330K – $410K • Offers Equity • Offers Bonus; Estimated Salary Range $330K – $410K • Offers Equity • Offers Bonus
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Job Details
- Experience
- Minimum of 15 years' experience
- Required Skills
- Risk Management
Requirements
- MD degree required.
- 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.
- Clinical and industry experience.
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.
- 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.
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