Director, Safety Scientist
About The Position
The Director, Safety Scientist plays a leadership role within Global Patient Safety organizing and mentoring safety scientists to actively evaluate, manage and strategize risk in collaboration with the GDS Medical Directors and cross-functional team members within the global regulatory framework. You will be responsible for: Leading risk management evaluation and resolution for assigned products and projects. Accountability for the following: Proven skill set for strategic leadership in a cross functional matrix Organize, train and/or support junior safety scientists and fellows across multiple product portfolios and/or indications Co-lead activities related to new drug applications and other regulatory filings Represent global patient safety at regulatory inspections i.e. MHRA, FDA, EMA, etc. Lead analysis to identify and address changes in global regulations including updates to SOP and process documentation Leading activities to identify and address process gaps Responsible for vendor management and training including budgets Responsible for overall project distribution across therapeutic area As needed represent GPS in global program teams and associated cross functional teams and/or projects Proactively provide guidance and educational training to GPS therapeutic teams Participate in ongoing safety data review and analysis for products in designated therapeutic areas. Responsible for Signal Review Meeting and Signal Management Team activities in collaboration with GPS Medical Directors Responsible for project managing and authoring of safety documents including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requests in collaboration safety physicians. Responsible for authoring safety section in collaboration with team members on regulatory responses, IBs/CCDS, protocol, ICF review, Data Monitoring Committees reports and requests, and other documents, and provide the necessary quality control to ensure alignment with core safety position. Manage portfolio of products/projects related to risk management; assists Safety Physicians in the development of risk management strategy and activities for assigned products
Requirements
- Advanced degree in a biologic/medical/clinical/nursing field: Pharmacist/PharmD, Nurse Practitioner or PhD with at least 7 years' experience in drug safety and risk management within the pharmaceutical, biotech or CRO industry
- Knowledge and understanding of US and EU safety regulations pre- and post- marketing
- Experience with Risk Management and Minimization programs
- Experience preparing post marketing safety regulatory documents including PSURs, PBRERs and Risk Management Plans
- Experience with clinical development including risk/benefit analysis and safety assessment
- Strong clinical, analytical, problem solving and scientific writing and communication skills
Nice To Haves
- Expertise with clinical and safety databases
- Experience in MedDRA coding and search strategies
- Excellent, independent judgment based on knowledge and expertise
- Strong personal time-management and project-management skills
- Mastery of Microsoft Word, PowerPoint and Excel
Responsibilities
- Leading risk management evaluation and resolution for assigned products and projects
- Strategic leadership in a cross functional matrix
- Organize, train and/or support junior safety scientists and fellows across multiple product portfolios and/or indications
- Co-lead activities related to new drug applications and other regulatory filings
- Represent global patient safety at regulatory inspections i.e. MHRA, FDA, EMA, etc.
- Lead analysis to identify and address changes in global regulations including updates to SOP and process documentation
- Leading activities to identify and address process gaps
- Responsible for vendor management and training including budgets
- Responsible for overall project distribution across therapeutic area
- Represent GPS in global program teams and associated cross functional teams and/or projects
- Proactively provide guidance and educational training to GPS therapeutic teams
- Participate in ongoing safety data review and analysis for products in designated therapeutic areas.
- Responsible for Signal Review Meeting and Signal Management Team activities in collaboration with GPS Medical Directors
- Responsible for project managing and authoring of safety documents including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requests in collaboration safety physicians.
- Responsible for authoring safety section in collaboration with team members on regulatory responses, IBs/CCDS, protocol, ICF review, Data Monitoring Committees reports and requests, and other documents, and provide the necessary quality control to ensure alignment with core safety position.
- Manage portfolio of products/projects related to risk management; assists Safety Physicians in the development of risk management strategy and activities for assigned products
Benefits
- qualified retirement programs
- paid time off (i.e., vacation, holiday, and leaves)
- health, dental, and vision coverage in accordance with the terms of the applicable plans
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
Number of Employees
5,001-10,000 employees
