Director of Safety Science
hace 3 semanas
At Alexion, we are seeking a highly skilled and experienced Director, Safety Science to join our Global Patient Safety team. As a key member of our organization, you will play a leadership role in organizing and mentoring safety scientists to actively evaluate, manage, and strategize risk in collaboration with cross-functional team members within the global regulatory framework.
Key Responsibilities:- Lead risk management evaluation and resolution for assigned products and projects
- 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
- Lead analysis to identify and address changes in global regulations, including updates to SOP and process documentation
- Identify and address process gaps
- Manage vendor relationships and training, including budgets
- Oversee project distribution across therapeutic areas
- Represent GPS in global program teams and associated cross-functional teams and/or projects
- 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
- 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
This role is generally conducted in an office environment.
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Director of Safety Science
hace 3 semanas
Barcelona, Barcelona, España Alexion A tiempo completoJob Title: Director of Safety ScienceAt Alexion, we are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be.Job Summary:We are seeking a highly skilled Director of...
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Director of Safety Science
hace 3 semanas
Barcelona, Barcelona, España Alexion A tiempo completoJob Title: Director of Safety ScienceAt Alexion, we are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be.Job Summary:We are seeking a highly skilled Director of...
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