Backed by GV.
About the role
The Director of Pharmacovigilance (PV) will provide strategic and operational support for the Company’s global pharmacovigilance and drug safety activities. This individual will contribute to the timely detection, evaluation, reporting, and communication of safety information in compliance with global regulatory requirements while supporting the development of innovative therapies from early clinical development through commercialization planning.
What they're looking for
- 8+ years of pharmacovigilance experience within biotechnology, pharmaceutical, or CRO settings
- Demonstrated support of global clinical development programs
- Experience managing outsourced pharmacovigilance vendors
- Strong understanding of global pharmacovigilance regulations, including FDA, EMA, PMDA and ICH
- Experience preparing aggregate safety reports and supporting regulatory submissions
- Prior experience participating in inspections or audits preferred
More about this role
The Director of Pharmacovigilance (PV) will provide strategic and operational support for the Company’s global pharmacovigilance and drug safety activities. This individual will contribute to the timely detection, evaluation, reporting, and communication of safety information in compliance with global regulatory requirements while supporting the development of innovative therapies from early clinical development through commercialization planning.
In this highly collaborative role, the Director will work closely with the VP Clinical Safety, Clinical Development, Clinical Operations, Medical Monitoring, Regulatory Affairs, Data Management, Biostatistics, Quality Assurance, and external pharmacovigilance vendors to maintain a high-quality safety program that supports patient safety and regulatory compliance.
- Oversee day-to-day pharmacovigilance activities performed internally and by external safety vendors.
- Ensure timely review, assessment, processing, tracking, medical evaluation, and regulatory reporting of adverse events, serious adverse events, SUSARs, and other safety information.Monitor vendor performance through KPIs, quality metrics, and governance meetings.
- Ensure...
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