7 дней назад
Vice President and Global Head of Drug Safety and Pharmacovigilance (DSPV)
365 000 - 497 000$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Vice President and Global Head of Drug Safety and Pharmacovigilance (DSPV) (Pharmacovigilance): Leading global pharmacovigilance strategy, medical safety oversight, regulatory compliance, and modernization of Insmed's PV infrastructure with an accent on rare disease safety science, global operations, and AI/ML-enabled innovation. Focus on transforming PV systems and workflows, maintaining inspection readiness, managing benefit-risk activities, and building a globally distributed safety organization.
Location: Fully remote; can be performed from anywhere. Frequent domestic and international travel of approximately 25% is expected for team meetings and events.
Salary: $365,000–$497,000 annual
Company
is a global biopharmaceutical company focused on transforming the lives of patients with serious and rare diseases.
What you will do
- Lead the global Drug Safety and Pharmacovigilance organization, including Medical Safety, EMEA QPPV operations, Japan PV operations, and operational excellence and compliance functions.
- Set the multi-year pharmacovigilance strategy and roadmap in alignment with the product pipeline and commercial growth.
- Oversee global safety surveillance, signal detection, risk management, benefit-risk communications, and medical safety deliverables.
- Lead enterprise-wide PV transformation, system modernization, workflow standardization, and adoption of AI/ML and advanced analytics.
- Maintain global regulatory compliance and inspection readiness across FDA, EMA, PMDA, GCP, GVP, GMP, and ICH frameworks.
- Collaborate with Clinical Development, Regulatory Affairs, Medical Affairs, Commercial, Quality, Legal/Compliance, health authorities, and patient advocacy organizations.
Requirements
- MD with 15+ years of drug development experience in a pharmaceutical or biotech company.
- 10+ years of pharmacovigilance or drug safety leadership experience and at least 5 years as a VP or equivalent with full PV organizational accountability.
- Experience leading a global PV organization, including safety strategy, compliance, operations, team performance, and large-scale organizational transformation.
- FDA and EMA inspection leadership experience, including experience as or supporting an EU/UK QPPV, plus experience with FDA, EMA, and PMDA interactions.
- Experience with BLA, NDA, MAA, or JNDA submissions, PV databases such as ARISg, Oracle Argus, or Veeva Vault Safety, MedDRA coding, and Microsoft Office.
- Strong executive leadership, communication, negotiation, financial management, vendor governance, KPI development, and cross-functional collaboration 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 connection to the team and community.
- Medical, dental, and vision coverage, mental health support, wellbeing reimbursement, and an Employee Assistance Program.
- Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
- 401(k) with company match, annual equity awards, ESPP, and company-paid life and disability insurance.
- Learning programs, mentorship, employee resource groups, recognition programs, and opportunities to volunteer.
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