Director, Safety Scientist, Gds

This is what you will do:

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:

• Leading activities to identify and address process gaps
• Co-lead activities related to new drug applications and other regulatory filings
• Participate in ongoing safety data review and analysis for products in designated therapeutic areas.
• Proven skill set for strategic leadership in a cross functional matrix
• As needed represent GPS in global program teams and associated cross functional teams and/or projects
• Responsible for Signal Review Meeting and Signal Management Team activities in collaboration with GPS Medical Directors
• 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.
• Proactively provide guidance and educational training to GPS therapeutic teams
• Responsible for vendor management and training including budgets
• Represent global patient safety at regulatory inspections i.e. MHRA, FDA, EMA, etc.
• Organize, train and/or support junior safety scientists and fellows across multiple product portfolios and/or indications
• Lead analysis to identify and address changes in global regulations including updates to SOP and process documentation
• Manage portfolio of products/projects related to risk management; assists Safety Physicians in the development of risk management strategy and activities for assigned products
• Responsible for overall project distribution across therapeutic area
• Responsible for project managing and authoring of safety documents including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requests in collaboration safety physicians.

You will need to have:

• 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
• 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
• Strong clinical, analytical, problem solving and scientific writing and communication skills
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
• Experience with Risk Management and Minimization programs

We would prefer for you to have:

• Expertise with clinical and safety databases
• Excellent, independent judgment based on knowledge and expertise
• Strong personal time-management and project-management skills
• Mastery of Microsoft Word, PowerPoint and Excel
• Experience in MedDRA coding and search strategies