Drug Safety Specialist- Safety Surveillance and Risk Management

Job Description

• Supports the signal management process (i.e set up process for periodic signal detection for company products, signal tracking, review meetings, signal detection overview reports, eRMR reports etc) for the assigned product (s) and evaluates safety data and signals as part of ongoing pharmacovigilance activities. Data from multiple sources are evaluated and authors the signal evaluation report and manages literature review for safety information.

• Prepares and maintains the Risk Management Plans (RMP)/Risk Evaluation and Mitigation Strategy (REMS) including the risk minimization measures and is responsible for the monitoring of the effectiveness of risk minimization measures.

• Supports the process for responding to safety questions from regulatory authorities and partners in collaboration with service providers and cross-func...