Senior Manager, Pharmacovigilance (Contractor)

The Senior Manager, Pharmacovigilance (Contractor) will be responsible for the management of safety data across our portfolio of products. The successful candidate will play a critical role in ensuring the safety of our patients by proactively monitoring and assessing adverse events, as well as working cross-functionally to ensure compliance with regulatory requirements. Lead and manage pharmacovigilance activities for our clinical-stage programs. Collaborate cross-functionally with clinical development, regulatory affairs, medical affairs, and other teams to ensure the safety of our products. Oversee the development and maintenance of pharmacovigilance processes and procedures. ICSR Management: Safety mailbox management, safety data collection, end-to-end case processing (book in, triage, data entry, query generation, quality review, evaluation, medical review including narrative writing) and reporting in compliance with applicable regional regulations and guidelines. Generation and distribution of (periodic) line listings to business partners. Contribute as needed to the preparation and review of safety sections of regulatory submissions. Coordinate and manage relationships with external vendors and partners involved in pharmacovigilance activities. Provide pharmacovigilance expertise and support for product development and lifecycle management activities.