Senior Manager, Safety Scientist

Boston, NH - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

This is what you will do:
The Senior Manager Safety Scientist plays a pivotal role within Global Drug Safety to ensure safety assessment for all Alexion products. The Senior Manager Safety Scientist in collaboration with Medical Directors Global Drug Safety are responsible for safety surveillance and risk management activities pertaining to Alexion products.

You will be responsible for:
Leading risk management evaluation and resolution for assigned products and projects. Accountability for the following:
Participating in ongoing safety data review and analysis for products in designated therapeutic areas
Signal Review Meeting and Signal Management Team activities in collaboration with GDS Medical Directors
Project managing and authoring of safety documents including PSUR PBER PADER RMP REMS CSRs and ad hoc requests in collaboration safety physicians
Authoring high quality aggregate safety reports to meet regulatory and internal deadlines; ensuring all safety regulatory documents are processed and submitted according to regulatory requirements
Authoring safety section in collaboration with team members on regulatory responses IBs/CCDS protocol ICF review Data Monitoring Committees reports and requests and other documents and providing the necessary quality control to ensure alignment with core safety position
Managing portfolio of products/projects related to risk management; assisting Safety Physicians in the development of risk management strategy and activities for assigned products
Assisting GDS Medical Directors to evaluate and oversee risk minimization activities including tracking of activities as needed
Assisting with responses to regulatory inquiries related to risk management plans under the guidance of GDS Medical Directors
Supporting activities related to new drug applications and other regulatory filings
Contributing to on-going process enhancement for safety analytics and reporting such as developing standard procedures and templates

You will need to have:
Bachelors degree in a biologic/medical/clinical/nursing field
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

The duties of this role are generally conducted in an office environment. As is typical of an office-based role employees must be able with or without an accommodation to: use a computer; engage in communications via phone video and electronic messaging; engage in problem solving and non-linear thought analysis and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:
Advanced degree in a biologic/medical/clinical/nursing field preferred: Pharmacist/PharmD Nurse Practitioner or PhD with at least 3 years of experience in pharmaceutical industry in drug safety/pharmacovigilance
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

Date Posted

10-Dec-2025

Closing Date

11-Dec-2025

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and 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.

Required Experience:

Senior Manager

This is what you will do:The Senior Manager Safety Scientist plays a pivotal role within Global Drug Safety to ensure safety assessment for all Alexion products. The Senior Manager Safety Scientist in collaboration with Medical Directors Global Drug Safety are responsible for safety surveillance and...