The Senior PV Scientist also serves as a Subject Matter Expert for SABR and cross-functional teams on relevant global safety regulations and guidelines; data output and analyses; and product specific information.
Leads the signal management process (i.e., signal tracking, leading review meetings, etc.) 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;
Collaborates with Global Safety Officers and other SABR 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;
Responsible for the SABR visualization tool for signal detection activities;
Leads the SABR visualization tool improvement process including working closely with the IT team, to fulfill all the requirements of visualization (training PV Scientists, collaborating with IT in resolving requests or questions from the PV scientist group);
Serves as subject matter expert for signaling processes and systems;
Leads and collaborates with Aggregate Reports on 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 6 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 scientific and medical data in verbal and written format;
Demonstrates leadership and interacts collaboratively and effectively in a team environment;
Leads and conducts, independently and/or collaboratively, all aspects of substantive projects such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests. Oversees and mentors less experienced PV Scientist staff;
Applies clinical judgment to interpret case information;
Strong Pharmacovigilance and drug development foundation, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes knowledge of case processing, expedited reporting rules, and safety database concepts;
Strong organizational skills, including the ability to prioritize independently with minimal supervision;
Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects). Knowledge of common safety database systems.
Bachelor’s Degree in biologic or natural science; or health case discipline or an Advanced degree (PhD, MPH, NP, PharmD, etc.).