Job Description

Overview Associate Director, Safety Scientist, Global Drug Safety-11264 at Alexion Pharmaceuticals, Inc. Join to apply for the Associate Director, Safety Scientist, Global Drug Safety-11264 role at Alexion Pharmaceuticals, Inc. This is what you will do: The Associate Director, Safety Scientist leads Global Patient Safety to actively evaluate and manage risk in collaboration with the GPS Medical Director and cross-functional teams within the global regulatory framework. You Will Be Responsible For Represent global drug safety at regulatory inspections (e.g., MHRA, FDA, EMA). Lead gap analysis to ensure alignment with changes in global regulations. Manage safety scientist activities across multiple product portfolios and/or indications. Strategize and draft responses to regulatory inquiries on product safety issues, including defining MedDRA search strategies. 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 GDS Medical Directors. Project manage and author safety documents including PSUR, PBRER, PADER, RMP, REMS, CSRs, and ad hoc requests with safety physicians. Author high-quality aggregate safety reports to meet regulatory and internal deadlines; ensure safety regulatory documents are processed and submitted according to regulatory requirements. Author safety sections in regulatory responses, IBs/CCDS, protocols, ICF reviews, Data Monitoring Committee reports and requests, and other documents, with quality control to align with core safety positions. Manage a portfolio of products/projects related to risk management; assist GDS Medical Directors in developing risk management strategy and activities for assigned products. Assist GDS Medical Directors to oversee risk minimization activities including tracking of activities as needed; assist in evaluating risk minimization activity. Assist with responses to regulatory inquiries related to risk management plans under the guidance of GDS Medical Directors. Support activities related to new drug applications and other regulatory filings. Contribute to ongoing process improvement for safety analytics and reporting, including developing standard procedures and templates. Assist in the review of Individual Case Safety Reports (ICSR) and analysis of similar events (AOSE) as necessary. Manage, train and/or support junior safety scientists and fellows. May be directed by the line function to support initiatives outside of their projects. You Will Need To Have Bachelor’s degree in a biologic/medical/clinical/nursing field. At least 5 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 analytical, problem-solving and scientific writing and communication skills. Ability to interact effectively with people of multiple disciplines and cultures on a global basis. Expertise with Microsoft Word, PowerPoint, SharePoint, and Excel. We Would Prefer For You To Have Advanced degree in a biologic/medical/clinical/nursing field preferred (PharmD, Nurse Practitioner, PhD). Expertise with clinical and safety databases. Experience in MedDRA coding and search strategies. Date Posted 12-Sep-2025 Closing Date 29-Sep-2025 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form. #J-18808-Ljbffr Alexion Pharmaceuticals, Inc.

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