Senior PV Scientist

The Senior PV Scientist team is responsible for overseeing and leading the process for safety signal management activities, aggregate reports, responding to safety questions from internal and external stakeholders, reviewing medical and scientific literature for safety information, and supporting Clinical Trial PV medical activities. The Senior PV Scientist also serves as a Subject Matter Expert for Safety and cross-functional teams on relevant global safety regulations and guidelines; data output and analyses; and product specific information.

Primary Responsibilities

• Leads the signal management process (i.e., signal detection, tracking, leading review meetings) for assigned product(s) and evaluates safety data and signals as part of ongoing pharmacovigilance activities. Includes synthesis of data from multiple sources and authoring signal evaluation reports.
• Leads signaling review process and product Safety Signaling Team meetings
• Manages literature review for safety information
• Collaborates with Global Safety Officers and other Safety MDs for assigned investigational programs including clinical trial activities (protocol review, ICF review, etc.), safety committee management, data analysis, signal detection, ad hoc requests and other product activities, as assigned
• Leads process for responding to safety questions from regulatory authorities
• Contributes to and leads initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety oversight, signal management and responding to ad hoc safety questions
• Leads Aggregate Report management, including strategy, review and finalization of aggregate safety reports for assigned products, such as PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and Risk Management Plans (RMPs).
• Minimum 7 years Pharmacovigilance experience, including experience in aggregate safety reports and safety signal management. Strong background in clinical trial drug safety is required.
• Understands, interprets, analyzes, and clearly presents scienti

We offer an exciting role were you will be an integral part of our Maidenhead Biogen team. You will as Senior Pharmacovigilance Scientist serve as a product lead for Pharmacovigilance activities within the Safety function.