The Drug Safety Physician will be responsible for pharmacovigilance, providing clinical support for drug safety, risk management, and regulatory reporting for all types of events. This individual will manage all aspects of DSMB, conducting risk communication, analysis, and compliance monitoring. They are responsible for maintaining safety data management and ensuring accurate reporting, adhering to FDA, EMA and ICH guidelines.
Requirements
- MD required, with a minimum of 7 years in Drug Safety related activities in pharma/biotech
- Clinical trial experience, including oncology drug safety with least 3 years being in early clinical development
- Experience authoring, reviewing, and providing input to drug-safety related regulatory reports
- Successful involvement in regulatory agency interactions or inspections
- Strong knowledge of FDA, EU, ICH and other global regulatory requirements for safety reporting and safety data and risk management
- Solid medical knowledge and familiarity with medical concepts and terminology used in hematology/oncology clinical trials and safety monitoring
- Proficiency with using standard computer applications (eg Microsoft Office, Windows) and safety databases
- Sense of urgency and ability to anticipate and respond quickly to emerging information
- Excellent oral and written communication skills
- Teamwork and collaborative approach
Originally posted on Himalayas
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