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SEB-210 - (Jo816) Director, Safety Science
Responder al anuncioJob 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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