Director, Pharmacovigilance
New
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Umoja BiopharmaBiotechnology
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
Requirements
- Advanced degree (PharmD, PhD, MD, or MS) or health-related degree/certification (PA, RN, NP).
- At least 10 years of pharmacovigilance experience in the biotech or pharmaceutical industry.
- Strong working knowledge of global pharmacovigilance regulations (FDA, EMA, ICH).
- Proven experience supporting clinical-stage programs.
- Experience working with outsourced PV models and managing vendors/CROs.
- Proficiency 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 travel as needed.
Responsibilities
- Oversee case processing activities including intake, triage, medical review support, and expedited reporting.
- Ensure compliance with global safety reporting requirements including FDA, EMA, and ICH guidelines.
- Manage relationships with PV vendors and CROs to ensure service quality, timeliness, and data integrity.
- Support maintenance of safety databases and related systems such as Argus or ArisGlobal.
- Lead or contribute to the preparation of DSURs, PSURs/PBRERs, and IND safety reports.
- Contribute to the development and maintenance of SOPs and the Pharmacovigilance System Master File (PSMF).
- Support signal detection activities including data review, trend analysis, and documentation.
- Develop and implement Risk Management Plans (RMPs).
- Drive continuous improvement initiatives and ensure PV processes remain audit- and inspection-ready.
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