Job Description

This individual is to lead medical assessment and interpretation of safety data from multiple sources, including clinical trials, and literature reports. The individual will be closely collaborating with cross functional teams in supporting all clinical development programs, regulatory filling, and global safety related activities. This individual will also support the clinical R&D team in the oversight of PV service vendors and partners and will need to maintain medical knowledge, as well as current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety surveillance and risk-management practices.
This role will report to the VP, Head of Pharmacovigilance.

• Provide medical safety input and participate in safety surveillance activities (e.g., identification of safety signals and ensure timely assessment and communication of confirmed safety signals).
• Provide input in the generation of aggregate safety reports (e.g., DSURs, PADER, PBRER).
• Serve as a leading medical safety resource for the development and review of clinical trial protocols, informed consent forms (ICFs), investigator brochures (IBs) and Reference Safety Information (RSI).
• Collaborate with Medical Monitors and Clinical Research Scientists and vendor clinical staff as needed for ongoing clinical trials.
• Provide medical safety input in the development and/or updates of Risk Management Plans and the maintenance of these documents.
• Provide support and input to the development of Standard Operating Procedures, Working Instructions, and other guidance documents.
• Serve as a subject matter expert for vendors that provide drug safety and pharmacovigilance services.
• Work closely with other Product Safety Leads to respond to and resolve safety questions from health authorities as well as regulatory agency's audits and inspections.

Qualifications

• 5+ years' experience in Drug Safety/Pharmacovigilance in a pharmaceutical or biotech company, CRO or regulatory agency.
• Medical Degree (MD) from a recognized medical school with medical practice experience. Oncology / Hematology experience strongly preferred.
• Strong working knowledge of US and EU drug safety and pharmacovigilance regulations, CIOMS and ICH guidelines.
• Proven experience in medical safety assessments, safety surveillance and risk management activities
• Proficiency with medical review of ICSRs, including expectedness assessments, causality assessments, narrative review and generation of Analysis of Similar Event and company comment statements, including benefit-risk assessment.
• Experience with preparation of aggregate reports (e.g., DSUR, PSUR/PBRER, PADER)
• Experience in preparation of responses to regulatory authorities; experience with regulatory filing and related activities preferred.

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