Director, Pharmacovigilance
New
This position will ideally be based out of our Seattle, WA office and work onsite at least 2 days/week. This position may have the ability to be remote in the US based on candidate experience.Full-TimeDirector
Salary204,000 - 305,000 USD per year
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Job Details
- Experience
- At least 10 years
- Required Skills
- Risk Management
Requirements
- Advanced degree (PharmD, PhD, MD, or MS) or health-related certification (PA, RN, NP).
- At least 10 years of pharmacovigilance experience in the biotech or pharmaceutical industry.
- Experience supporting clinical-stage programs.
- Demonstrated experience working with outsourced PV models.
- Strong working knowledge of global pharmacovigilance regulations (FDA, EMA, ICH).
- Hands-on experience with safety databases and case processing workflows.
- Familiarity with aggregate reporting and signal detection processes.
- Strong execution focus with attention to detail and quality.
- Ability to manage external partners and influence cross-functional teams.
- Ability to travel to Seattle, WA as needed.
Responsibilities
- Oversee case processing activities including intake, triage, medical review, and expedited reporting.
- Manage relationships with PV vendors and CROs to ensure quality and compliance.
- Lead or contribute to preparation of DSURs, PSURs/PBRERs, and IND safety reports.
- Conduct signal detection activities, trend analysis, and documentation.
- Develop and maintain SOPs and Pharmacovigilance System Master File (PSMF).
- Partner with Clinical Development and Regulatory Affairs on safety reporting and protocol safety design.
- Ensure PV processes remain audit- and inspection-ready.
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