This role involves leading the medical evaluation and interpretation of safety data from various sources, including clinical trials and literature reports. The individual will work closely with cross-functional teams to support all clinical development programs, regulatory filings, and global safety activities. Additionally, this person will assist the clinical R&D team in overseeing PV service vendors and partners, maintaining up-to-date medical knowledge and expertise in drug safety and pharmacovigilance regulations, practices, safety surveillance, and risk management.
Hiring Manager: This position reports to the VP, Head of Pharmacovigilance.
Key Responsibilities:
- Provide medical safety input and engage in safety surveillance activities, such as identifying safety signals and ensuring timely assessment and communication of confirmed signals.
- Contribute to the creation of aggregate safety reports (e.g., DSURs, PADER, PBRER).
- Act as a primary medical safety resource for developing and reviewing clinical trial protocols, informed consent forms (ICFs), investigator brochures (IBs), and Reference Safety Information (RSI).
- Collaborate with Medical Monitors, Clinical Research Scientists, and vendor clinical staff as needed for ongoing clinical trials.
- Offer medical safety input in the development and updates of Risk Management Plans and maintain these documents.
- Support the development of Standard Operating Procedures, Working Instructions, and other guidance documents.
- Serve as a subject matter expert for vendors providing drug safety and pharmacovigilance services.
- Work closely with other Product Safety Leads to address and resolve safety questions from health authorities and during regulatory agency audits and inspections.
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