Job Title: Director, Safety Science
Location: Barcelona, Catalonia
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.
Responsibilities: Leading risk management evaluation and resolution for assigned products and projects.Accountability 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.Identify and address process gaps.Responsible for vendor management and training including budgets.Manage overall project distribution across therapeutic areas.Represent GPS in global program teams and associated cross-functional teams and/or projects as needed.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.Project manage and author safety documents including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requests in collaboration with safety physicians.Author safety sections in collaboration with team members on regulatory responses, IBs/CCDS, protocol, ICF review, Data Monitoring Committees reports and requests, ensuring alignment with core safety position.Manage a portfolio of products/projects related to risk management; assist 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, scientific writing and communication skills.The duties of this role are generally conducted in an office environment.
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