Alexion Pharmaceuticals, Inc.
Associate Director, Safety Scientist
Alexion Pharmaceuticals, Inc., Boston, Massachusetts, us, 02298
Associate Director, Safety Scientist
Alexion Pharmaceuticals, Inc.
The Associate Director, Safety Scientist plays a leadership role within Global Patient Safety (GPS) to actively evaluate and manage risk in collaboration with the GPS Medical Director(s) and cross‑functional team members within the global regulatory framework.
Date Posted: 18-Dec-2025
Closing Date: 04-Jan-2026
Responsibilities
Managing safety scientist activities across multiple product portfolios and/or indications
Organizing, training and/or supporting junior safety scientists and fellows
Supporting activities related to new drug applications and other regulatory filings
Representing global patient safety at regulatory inspections (e.g., MHRA, FDA, EMA, etc.)
Leading gap analysis to ensure alignment with changes in global regulations
Strategizing and drafting responses to regulatory inquiries on product safety issues, including defining MedDRA search strategy
Representing GPS in global program teams and associated cross‑functional teams and/or projects as needed
Proactively providing guidance and educational training to GPS therapeutic teams
Responsible for Signal Review Meeting and Signal Management Team activities in collaboration with GPS Medical Directors
Performing signal surveillance activities for respective programs in collaboration with GPS Medical Directors
Project‑managing and authoring safety documents including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad‑hoc requests in collaboration with GPS Medical Directors
Authoring safety sections, in collaboration with team members, on regulatory responses, IBs/CCDS, protocols, ICFs, Data Monitoring Committee reports and requests, and other documents, and providing the necessary quality control to ensure alignment with core safety position.
Managing a portfolio of products/projects related to risk management; assisting GPS Medical Directors in the development of risk management strategy and activities for assigned products
Contributing to ongoing process enhancement for safety analytics and reporting, such as developing standard procedures and templates
Assisting GPS Medical Directors to oversee risk minimization activities, including tracking of activities as needed
May be directed by the line function to support initiatives outside of their projects
Qualifications
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 clinical, analytical, problem‑solving and scientific writing and communication skills
Ability to interact effectively with people of multiple disciplines and cultures both within and outside the company on a global basis
Expertise with Microsoft Word, PowerPoint, SharePoint and Excel
Nice to Have
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
Excellent, independent judgment based on knowledge and expertise
Strong personal time‑management and project‑management skills
Knowledge of Power BI and other visualization tools
Compensation & Benefits The annual base pay ranges from $126,000 to $190,000. Positions offer eligibility for various incentives—short‑term incentive bonuses, equity‑based awards for salaried roles and commissions for sales roles. Benefits include qualified retirement programs, paid time off (vacation, holiday, and leaves), and health, dental, and vision coverage in accordance with applicable plans.
EEO Statement 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.
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The Associate Director, Safety Scientist plays a leadership role within Global Patient Safety (GPS) to actively evaluate and manage risk in collaboration with the GPS Medical Director(s) and cross‑functional team members within the global regulatory framework.
Date Posted: 18-Dec-2025
Closing Date: 04-Jan-2026
Responsibilities
Managing safety scientist activities across multiple product portfolios and/or indications
Organizing, training and/or supporting junior safety scientists and fellows
Supporting activities related to new drug applications and other regulatory filings
Representing global patient safety at regulatory inspections (e.g., MHRA, FDA, EMA, etc.)
Leading gap analysis to ensure alignment with changes in global regulations
Strategizing and drafting responses to regulatory inquiries on product safety issues, including defining MedDRA search strategy
Representing GPS in global program teams and associated cross‑functional teams and/or projects as needed
Proactively providing guidance and educational training to GPS therapeutic teams
Responsible for Signal Review Meeting and Signal Management Team activities in collaboration with GPS Medical Directors
Performing signal surveillance activities for respective programs in collaboration with GPS Medical Directors
Project‑managing and authoring safety documents including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad‑hoc requests in collaboration with GPS Medical Directors
Authoring safety sections, in collaboration with team members, on regulatory responses, IBs/CCDS, protocols, ICFs, Data Monitoring Committee reports and requests, and other documents, and providing the necessary quality control to ensure alignment with core safety position.
Managing a portfolio of products/projects related to risk management; assisting GPS Medical Directors in the development of risk management strategy and activities for assigned products
Contributing to ongoing process enhancement for safety analytics and reporting, such as developing standard procedures and templates
Assisting GPS Medical Directors to oversee risk minimization activities, including tracking of activities as needed
May be directed by the line function to support initiatives outside of their projects
Qualifications
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 clinical, analytical, problem‑solving and scientific writing and communication skills
Ability to interact effectively with people of multiple disciplines and cultures both within and outside the company on a global basis
Expertise with Microsoft Word, PowerPoint, SharePoint and Excel
Nice to Have
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
Excellent, independent judgment based on knowledge and expertise
Strong personal time‑management and project‑management skills
Knowledge of Power BI and other visualization tools
Compensation & Benefits The annual base pay ranges from $126,000 to $190,000. Positions offer eligibility for various incentives—short‑term incentive bonuses, equity‑based awards for salaried roles and commissions for sales roles. Benefits include qualified retirement programs, paid time off (vacation, holiday, and leaves), and health, dental, and vision coverage in accordance with applicable plans.
EEO Statement 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.
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