Drug Safety Program Manager

Job description

The Drug Safety Manager will have primary responsibility for the following, providing end‑to‑end safety leadership across clinical studies and marketed products. Clinical Study Safety Management & Planning - Serve as the PV Safety Program Lead for assigned clinical studies, with end‑to‑end accountability for safety oversight from study startup through closeout. - Ensure study‑specific Safety Management Plans (SMPs) are developed, approved, implemented, and maintained in accordance with ICH guidelines, regulatory requirements, and Alkermes SOPs. - Ensure all required safety forms, templates, and documentation are in place and aligned across systems and vendors, including but not limited to SAE and pregnancy reporting forms, narrative templates, IND safety report cover letters, fax cover sheets, and study‑specific safety documentation. - Review protocols, protocol amendments, and protocol update request forms for safety accuracy, completeness, and regulatory compliance. - Act as the PV representative on clinical project teams, ensuring safety considerations are integrated into study conduct, risk management, and decision‑making. Case Processing, Reporting & Compliance: - Responsible...