Alexion Pharmaceuticals, Inc. · 23 hours ago
Director, Safety Scientist
Boston, MA
Full-time
Onsite
Director/Executive
$175K/yr - $263K/yr
7+ years expAlexion Pharmaceuticals, Inc. is seeking a Director, Safety Scientist to lead in Global Patient Safety. The role involves organizing and mentoring safety scientists, managing risk evaluation, and collaborating with cross-functional teams within the regulatory framework.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
Leading risk management evaluation and resolution for assigned products and projects
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 i.e. MHRA, FDA, EMA, etc
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 safety physicians
Responsible for 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 provide the necessary quality control to ensure alignment with core safety position
Manage portfolio of products/projects related to risk management; assists Safety Physicians in the development of risk management strategy and activities for assigned products
Qualification
Required
Advanced degree in a biologic/medical/clinical/nursing field: Pharmacist/PharmD, Nurse Practitioner or PhD with at least 7 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
Preferred
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
Benefits
Qualified retirement programs
Paid time off (i.e., vacation, holiday, and leaves)
Health, dental, and vision coverage in accordance with the terms of the applicable plans
Company
Alexion Pharmaceuticals, Inc.
Alexion, AstraZeneca Rare Disease is focused on pioneering new possibilities for the rare disease community.
1001-5000 employees
H1B Sponsorship
Alexion Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (49)
2024 (57)
2023 (51)
2022 (29)
2021 (27)
2020 (17)
Funding
Current Stage
Public CompanyTotal Funding
$5.8M2020-12-12Acquired
1999-02-12Post Ipo Equity· $5.8M
1996-02-29IPO
Leadership Team
Frederic Chereau
SVP, Strategy and Business Development
Imran Shakur
Director, IRT and Technology Lead
Recent News
bloomberglaw.com
2025-12-20
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