5 дней назад
Vice President and Global Head of Drug Safety and Pharmacovigilance
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Vice President and Global Head of Drug Safety and Pharmacovigilance (Pharmacovigilance/Drug Safety): Setting the strategic direction for a global drug safety organization and transforming PV infrastructure, processes, and technology with an accent on safety surveillance, regulatory compliance, and medical oversight. Focus on leading global PV operations, implementing AI/ML-enabled workflows, managing FDA, EMA, and PMDA interactions, and building high-performing distributed teams.
Location: Fully remote; can be performed from anywhere. Frequent domestic and international travel of approximately 25% is expected for team meetings, events, and other business needs.
Company
is a global biopharmaceutical company focused on transforming the lives of patients with serious and rare diseases.
What you will do
- Set the strategic direction for the global Drug Safety and Pharmacovigilance organization and execute a multi-year PV roadmap.
- Lead an enterprise-wide transformation of global PV infrastructure, processes, systems, and technology.
- Oversee global safety surveillance, signal detection, risk management, medical safety deliverables, and benefit-risk communications.
- Ensure pharmacovigilance compliance and inspection readiness across global markets, including FDA, EMA, and PMDA requirements.
- Lead EMEA QPPV and Japan PV operations, REMS activities, global Risk Management Plans, and health authority interactions.
- Build and develop a globally distributed PV organization while managing budgets, vendors, KPIs, and cross-functional partnerships.
Requirements
- MD degree, 15+ years of drug development experience in a pharmaceutical or biotech company, and 10+ years of PV or drug safety leadership.
- At least 5 years of experience as a VP or equivalent with full PV organizational accountability, plus 4+ years of post-doctoral clinical experience.
- Experience leading a global PV organization, including safety strategy, compliance, operations, team performance, and organizational transformation.
- FDA and EMA inspection leadership experience and experience as or supporting an EU/UK QPPV.
- Experience with BLA, NDA, MAA, and JNDA submissions, health authority interactions, PV technology modernization, and AI/ML applications in pharmacovigilance.
- Proficiency with ARISg, Oracle Argus, Veeva Vault Safety, MedDRA coding, and Microsoft Office Suite, along with strong executive leadership, communication, negotiation, and budget management skills.
Nice to have
- Specialty Board Certification.
- Advanced degree in Pharmaceutical Medicine, Epidemiology/Public Health, or Regulatory Science.
- Rare disease experience.
Culture & Benefits
- Fully remote work with purposeful in-person collaboration and support for flexible work schedules.
- Medical, dental, vision, and mental health coverage, wellbeing reimbursement, and an Employee Assistance Program.
- Paid time off, fertility and family-forming benefits, caregiver support, life and disability insurance, and a 401(k) plan with company matching.
- Annual equity awards, Employee Stock Purchase Plan participation, learning programs, mentorship, and leadership development opportunities.
- Employee resource groups, service programs, recognition initiatives, and opportunities to volunteer and give back.
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