Job Title: Associate Director, Safety Scientist, Global Drug Safety
Location: Boston, Massachusetts, United States
Job ID: R-219509
Date posted: 21/03/2025
About the Company:
AstraZeneca is a global biopharmaceutical company driven by the desire to make a real difference in patients’ lives. We focus on areas of high unmet medical need and harness the latest advancements in science and technology to deliver life-changing medicines.
Job Responsibilities:
Regulatory Inspections & Gap Analysis:
Represent global drug safety at regulatory inspections (MHRA, FDA, EMA, etc.)
Lead gap analysis to ensure alignment with global regulatory changes
Manage safety scientist activities across multiple product portfolios/indications
Safety Data Review & Risk Management:
Participate in ongoing safety data review and analysis for designated therapeutic areas
Responsible for Signal Review Meeting and Signal Management Team activities in collaboration with GDS Medical Directors
Oversee risk minimization activities, including tracking of activities
Safety Documentation & Reporting:
Project manage and author safety documents, including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requests
Ensure all safety regulatory documents meet internal deadlines and are processed and submitted according to regulatory requirements
Author safety sections for regulatory responses, IBs/CCDS, protocol, ICF review, Data Monitoring Committees reports, etc.
Regulatory Filings & Risk Management Strategy:
Support activities related to new drug applications and other regulatory filings
Assist in the development of risk management strategies for assigned products in collaboration with GDS Medical Directors
Contribute to process enhancement for safety analytics and reporting, including developing standard procedures and templates
Team Development & Mentorship:
Manage, train, and/or support junior safety scientists and fellows
Assist with responses to regulatory inquiries related to risk management plans under the guidance of GDS Medical Directors
Required Qualifications:
Education:
Bachelor’s degree in a biologic/medical/clinical/nursing field
Experience:
At least 5 years of 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 preparing post-marketing safety regulatory documents (e.g., PSURs, PBRERs, Risk Management Plans)
Strong analytical, problem-solving, scientific writing, and communication skills
Skills:
Proficient in Microsoft Word, PowerPoint, SharePoint, and Excel
Ability to interact effectively with global teams and stakeholders across multiple disciplines and cultures
Preferred Qualifications:
Advanced Education:
Advanced degree in a biologic/medical/clinical/nursing field (Pharmacist/PharmD, Nurse Practitioner, or PhD)
Experience:
Expertise with clinical and safety databases
Experience in MedDRA coding and search strategies
Compensation and Benefits:
Salary:
Salary will be based on experience and qualifications
Benefits:
AstraZeneca offers a comprehensive benefits package including health coverage, retirement plans, paid leave, and more
Andra Pradesh :
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Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
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