обновлено 1 день назад
Associate Director, Pharmacovigilance (Biotech)
179 000 - 232 500$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Associate Director, Pharmacovigilance (Biotech): Providing medical expertise for safety and risk assessment of products across the clinical and post-marketing lifecycle with an accent on medical review, regulatory reporting, and benefit-risk analysis. Focus on ensuring safety data integrity, managing emerging safety signals, and supporting global risk management initiatives.
Location: Must be based in the U.S. (Fully remote role with occasional travel).
Salary: $179,000–$232,500 Annual
Company
is a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases.
What you will do
- Perform medical significance and expectedness assessments of AE/SAE reports and review case narratives.
- Compile AOSE, RMP analyses, and ad-hoc safety reports for health authorities.
- Investigate emerging safety data from clinical trials, literature, and spontaneous ADR reports.
- Author and review regulatory documents including protocols, ISS, ISE, and product labeling.
- Collaborate with drug safety vendors and participate in internal safety review committee meetings.
- Provide medical input for maintaining RMP and post-marketing safety monitoring commitments.
Requirements
- Must have 3-5 years of experience in a safety officer or pharmacovigilance leadership role within the pharmaceutical industry.
- Degree required: Masters in life sciences, RN, PharmD, or MD.
- Expert knowledge of pharmacovigilance regulations and MedDRA coding.
- Strong leadership skills with the ability to communicate across all organizational levels.
- Must be authorized to work in the U.S.
Nice to have
- Device experience is strongly preferred.
Culture & Benefits
- Comprehensive medical, dental, and vision coverage with mental health support.
- 401(k) plan with company match and annual equity awards.
- Generous paid time off and flexible work schedules.
- Access to the Company Learning Institute for professional development.
- Employee resource groups and service programs.
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