Senior Drug Safety Manager
Maidenhead, United Kingdom
Job ID: 30759BR
Job Description Primary Responsibilities
The Senior Drug Safety Manager is a member of the Safety Surveillance and Aggregate Reporting (SSA) team. This team is a critical group within the Safety and Benefit Risk Management (SABR) department at Biogen, responsible for activities associated with aggregate safety reporting and vendor management. The Senior Drug Safety Manager role leads many Pharmacovigilance activities to ensure the safety of Biogen products throughout the product life cycle. The ideal candidate for the Senior Drug Safety Manager role will have excellent written and verbal communication skills; demonstrated leadership skills; strong presentation skills; and extensive medical writing, editing, and source document review.
- Oversee the process for scheduling, planning, managing, and authoring aggregate safety reports for all Biogen investigational and marketed products; including PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and EU Risk Management Plans.
- In order to ensure a seamless transition from signal management to aggregate report writing, the Senior PV Scientist will collaborate with the product lead PV Scientist to understand the product’s risk profile, safety and benefit risk considerations, evaluated signals, and events of interest.
- The Senior PV Scientist will provide oversight to any contracted vendors involved in the preparation (e.g., document management and authoring) of assigned aggregate safety reports. The Senior PV Scientist will have oversight for the quality of all assigned aggregate reports including those prepared internally or through contracted vendors.
- Senior PV Scientist serves as the subject matter expert on aggregate safety reporting requirements, practices and documentation for the PV Scientist group, SABR and other cross-functional collaborators. This includes PSUR, DSUR and RMP requirements.
- In collaboration with PV Scientist team, lead initiatives for process improvement and efficiencies and represent PV Scientists in cross-SABR discussions regarding processes, databases, etc. Contributing to SOPs, job aids and templates aggregate reports.
- Serves as leader and expert for SABR regarding Global RMPs, including current regulations, tracking, content and strategy.
- Mentoring junior PV Scientists and helping to train new PV Scientist staff members.
- Ability to lead and the aggregate safety reporting and risk management initiatives for a given product, including: setting strategy for PV activities for the product specifically around aggregate safety reports and risk management plans; proactively identifying and solving problems; communicating with Senior Management regarding product updates and safety; and mentoring other PV Scientists on the product team.
- Ability to understand, interpret, analyze, and clearly present scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology).
- Able to interact collaboratively and effectively in a team environment (including Biostatistics, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues.
- Ability to oversee vendor responsible for outsourced activities, and to provide project management skills to ensure deliverables from internal and external contributors are completed on time with high quality.
- Able to develop and conduct, independently and/or collaboratively, all aspects of aggregate safety reports, risk management plans and responses to associated regulatory agency requests.
- Able to apply clinical judgment to interpret case information and help lead the product team in decision making.
- Strong Pharmacovigilance and drug development foundation, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes basic 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.
- Academic degree in biological or natural science or health care discipline (e.g. PhD, MPH, NP, Pharm D, MSc).
- Minimum 7 years of industry experience working in the pharmacovigilance discipline preferred.