Senior Manager, Pharmacovigilance And Risk Management

Job Description
The Associate Director/Senior Manager, Pharmacovigilance and Risk Management, serves as a critical medical and data analytical role for the assigned investigational and/or marketed product(s). The successful candidate is expected to be equally effective working independently as well as collaboratively. She/he must possess knowledge and skills to ensure that safety data analyses and reports are of high quality and in adherence to requirements and regulatory timelines. Accountability in leading and managing projects as well as ability to analyze, interpret, and effectively communicate data is a key success factor for this role.
The position may be filled at the Associate Director or Senior Manager level and will report to the Pharmacovigilance Risk Management Lead in Waltham, MA.
What You’ll Do:
Serve as the analytical safety lead for the assigned program(s)/product(s).
Responsible for signal management, including signal detection, signal investigation, and preparation of signal evaluation reports, including input into a design of a comprehensive safety surveillance system.
Review data outputs and literature, interpret and communicate findings.
Analyze data for aggregate safety reports (e.G., DSURs, PADERs, PBRERs), and ad-hoc regulatory requests.
Support Risk Management Plan (RMP) related activities.
Participate in regulatory submission activities (NDA, MAA) and support ad-hoc query responses to health authorities.