2 дня назад
Associate Director, Pharmacovigilance/Product Safety (Pharmacovigilance)
164 000 - 213 000$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Associate Director, Pharmacovigilance/Product Safety (Pharmacovigilance): Evaluating medical safety and risk for biopharmaceutical products across clinical development and post-marketing with an accent on adverse-event assessment, benefit-risk analysis, and regulatory documentation. Focus on investigating emerging safety data, maintaining risk management plans, reviewing case narratives, and supporting safety oversight across the product life cycle.
Location: Fully remote; can be performed from anywhere. Occasional travel for team meetings or events is expected, up to 10% annually. The posting also lists Bridgewater, New Jersey, United States as the company location.
Salary: $164,000–$213,000 annually
Company
is a global biopharmaceutical company developing treatments for patients with serious and rare diseases.
What you will do
- Provide medical expertise for safety and risk assessment across clinical development and post-marketing activities.
- Assess the medical significance and expectedness of adverse-event and serious-adverse-event reports and approve case narratives.
- Compile analyses of similar events, individual cases, risk management plans, and ad hoc safety data.
- Investigate emerging safety information from clinical trials, spontaneous reports, literature, aggregate reports, toxicology, and non-clinical studies.
- Author, review, and approve drug-safety regulatory reports and clinical documents, including protocols, investigator brochures, integrated safety summaries, MedDRA coding, and product labeling.
- Collaborate with safety vendors and participate in internal safety review committee meetings.
Requirements
- Master’s degree in life sciences, RN, PharmD, or MD.
- At least 3–5 years of experience as a safety officer or in a similar pharmacovigilance leadership role in the pharmaceutical industry.
- Strong experience managing safety information from clinical development and post-marketing sources.
- Expert knowledge of pharmacovigilance regulations and working knowledge of industry-standard pharmacovigilance databases and MedDRA.
- Strong leadership, communication, organization, attention to detail, clarity, accuracy, and conciseness.
- Device experience is strongly preferred.
Culture & Benefits
- Fully remote work with purposeful in-person collaboration and occasional team travel.
- Medical, dental, vision, and mental health coverage, plus annual 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 participation, and company-paid life and disability insurance.
- Learning resources, leadership programs, mentorship, employee resource groups, and service and recognition programs.
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