Alexion Pharmaceuticals, Inc.
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Director, Safety Scientist
role at
Alexion Pharmaceuticals, Inc.
1 day ago Be among the first 25 applicants
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
Proven skill set 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 (e.g., MHRA, FDA, EMA)
Lead analysis to identify and address changes in global regulations, including updates to SOP and process documentation
Leading activities to identify and address process gaps
Responsible for vendor management and training, including budgets
Responsible for overall project distribution across therapeutic area
As needed represent GPS in global program teams and associated cross‑functional teams and/or projects
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
Responsible for project‑managing and authoring of safety documents including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requests in collaboration with safety physicians
Responsible for authoring safety sections in collaboration with team members on regulatory responses, IBs/CCDS, protocol, ICF review, Data Monitoring Committee reports and requests, and other documents, and providing necessary quality control to ensure alignment with core safety position
Manage portfolio of products/projects related to risk management; assist Safety Physicians in developing risk‑management strategy and activities for assigned products
Qualifications
Advanced degree in a biologic/medical/clinical/nursing field: Pharmacist/PharmD, Nurse Practitioner, or PhD with at least 7 years of experience in drug safety and risk management within the pharmaceutical, biotech, or CRO industry
Knowledge and understanding of U.S. and EU safety regulations before and after 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
Preferred Qualifications
Expertise with clinical and safety databases
Experience in MedDRA coding and search strategies
Excellent, independent judgment based on knowledge and expertise
Strong personal time‑management and project‑management skills
Mastery of Microsoft Word, PowerPoint and Excel
Compensation & Benefits The annual base pay for this position ranges from $175,000 to $263,000. Our positions offer eligibility for various incentives—including short‑term incentive bonuses, equity‑based awards for salaried roles, and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (vacation, holidays, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
Application Dates Date Posted: 18‑Dec‑2025
Closing Date: 04‑Jan‑2026
EEO Statement 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.
Additional Information Seniority Level: Director
Employment Type: Full‑time
Job Function: Management and Manufacturing
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Director, Safety Scientist
role at
Alexion Pharmaceuticals, Inc.
1 day ago Be among the first 25 applicants
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
Proven skill set 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 (e.g., MHRA, FDA, EMA)
Lead analysis to identify and address changes in global regulations, including updates to SOP and process documentation
Leading activities to identify and address process gaps
Responsible for vendor management and training, including budgets
Responsible for overall project distribution across therapeutic area
As needed represent GPS in global program teams and associated cross‑functional teams and/or projects
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
Responsible for project‑managing and authoring of safety documents including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requests in collaboration with safety physicians
Responsible for authoring safety sections in collaboration with team members on regulatory responses, IBs/CCDS, protocol, ICF review, Data Monitoring Committee reports and requests, and other documents, and providing necessary quality control to ensure alignment with core safety position
Manage portfolio of products/projects related to risk management; assist Safety Physicians in developing risk‑management strategy and activities for assigned products
Qualifications
Advanced degree in a biologic/medical/clinical/nursing field: Pharmacist/PharmD, Nurse Practitioner, or PhD with at least 7 years of experience in drug safety and risk management within the pharmaceutical, biotech, or CRO industry
Knowledge and understanding of U.S. and EU safety regulations before and after 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
Preferred Qualifications
Expertise with clinical and safety databases
Experience in MedDRA coding and search strategies
Excellent, independent judgment based on knowledge and expertise
Strong personal time‑management and project‑management skills
Mastery of Microsoft Word, PowerPoint and Excel
Compensation & Benefits The annual base pay for this position ranges from $175,000 to $263,000. Our positions offer eligibility for various incentives—including short‑term incentive bonuses, equity‑based awards for salaried roles, and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (vacation, holidays, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
Application Dates Date Posted: 18‑Dec‑2025
Closing Date: 04‑Jan‑2026
EEO Statement 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.
Additional Information Seniority Level: Director
Employment Type: Full‑time
Job Function: Management and Manufacturing
#J-18808-Ljbffr