Alexion Pharmaceuticals, Inc.
Associate Director, Safety Scientist, Global Patient Safety
Alexion Pharmaceuticals, Inc., Boston, Massachusetts, us, 02298
Associate Director, Safety Scientist, Global Patient Safety
Join to apply for the Associate Director, Safety Scientist, Global Patient Safety role at Alexion Pharmaceuticals, Inc. Overview
The Associate Director, Safety Scientist plays a leadership role within Global Patient Safety to actively evaluate and manage risk in collaboration with the GPS Medical Director and cross-functional team members within the global regulatory framework. Responsibilities
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 strategy. Participate in ongoing safety data review and analysis for products in designated therapeutic areas. Coordinate Signal Review Meetings and Signal Management Team activities with GDS Medical Directors. Project manage and author safety documents including PSUR, PBRER, PADER, RMP, REMS, CSRs, and ad hoc requests in collaboration with safety physicians. Author high-quality aggregate safety reports to meet regulatory and internal deadlines and ensure submission per regulatory requirements. Author safety sections in collaboration with team members on regulatory responses, IBs/CCDS, protocol, ICF review, DMC reports, and related documents; provide quality control for alignment with core safety position. Manage a portfolio of products/projects related to risk management; assist GDS Medical Directors in risk management strategy development. Assist in overseeing risk minimization activities, including tracking and evaluation as needed. Assist with responses to regulatory inquiries related to risk management plans under guidance of GDS Medical Directors. Support activities related to new drug applications and other regulatory filings. Contribute to process improvements for safety analytics and reporting, including development of standard procedures and templates. Assist in the review of Individual Case Safety Reports (ICSR) and analysis of related events as necessary. Manage, train, and/or support junior safety scientists and fellows. May be directed to support initiatives outside of assigned projects. Qualifications
Required
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. Preferred
Advanced degree in a biologic/medical/clinical/nursing field preferred (Pharmacist/PharmD, Nurse Practitioner or PhD). Expertise with clinical and safety databases. Experience in MedDRA coding and search strategies. EEO statement: Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
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Join to apply for the Associate Director, Safety Scientist, Global Patient Safety role at Alexion Pharmaceuticals, Inc. Overview
The Associate Director, Safety Scientist plays a leadership role within Global Patient Safety to actively evaluate and manage risk in collaboration with the GPS Medical Director and cross-functional team members within the global regulatory framework. Responsibilities
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 strategy. Participate in ongoing safety data review and analysis for products in designated therapeutic areas. Coordinate Signal Review Meetings and Signal Management Team activities with GDS Medical Directors. Project manage and author safety documents including PSUR, PBRER, PADER, RMP, REMS, CSRs, and ad hoc requests in collaboration with safety physicians. Author high-quality aggregate safety reports to meet regulatory and internal deadlines and ensure submission per regulatory requirements. Author safety sections in collaboration with team members on regulatory responses, IBs/CCDS, protocol, ICF review, DMC reports, and related documents; provide quality control for alignment with core safety position. Manage a portfolio of products/projects related to risk management; assist GDS Medical Directors in risk management strategy development. Assist in overseeing risk minimization activities, including tracking and evaluation as needed. Assist with responses to regulatory inquiries related to risk management plans under guidance of GDS Medical Directors. Support activities related to new drug applications and other regulatory filings. Contribute to process improvements for safety analytics and reporting, including development of standard procedures and templates. Assist in the review of Individual Case Safety Reports (ICSR) and analysis of related events as necessary. Manage, train, and/or support junior safety scientists and fellows. May be directed to support initiatives outside of assigned projects. Qualifications
Required
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. Preferred
Advanced degree in a biologic/medical/clinical/nursing field preferred (Pharmacist/PharmD, Nurse Practitioner or PhD). Expertise with clinical and safety databases. Experience in MedDRA coding and search strategies. EEO statement: Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
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