Job Description
This is what you will do: The Associate Director, Safety Scientist plays a leadership role within Global Patient Safety to actively evaluate and manage risk in collaboration with the GPS Medical Director and cross-functional team members within the global regulatory framework
You will be responsible for: - Represent global drug safety at regulatory inspections i.e. MHRA, FDA, EMA, etc.
- Lead gap analysis to ensure alignment with changes in global regulations
- Manage safety scientist activities across multiple product portfolios and/or indications
- Strategizing and drafting of responses to regulatory inquiries on product safety issues inclusive of defining MedDRA search strategy
- 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 GDS 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.
- Authors high-quality aggregate safety reports to meet regulatory and internal deadlines; ensures all safety regulatory documents are processed and submitted according to regulatory requirements
- 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 a portfolio of products/projects related to risk management; assists GDS Medical Directors in the development of risk management strategy and activities for assigned products
- Assists GDS Medical Directors to oversee risk minimization activities including tracking of activities as needed
- Assists in the evaluation of risk minimization activity
- Assist with responses to regulatory inquiries related to risk management plans under the guidance of GDS Medical Directors.
- Supports activities related to new drug applications and other regulatory filings
- Contribute to ongoing process enhancement for safety analytics and reporting, such as developing standard procedures and templates
- Assist in the review of Individual Case Safety Report (ICSR) and analysis of similar events (AOSE) as necessary
- Manage, train and/or support junior safety scientists and fellows
- May be directed by the line function to support initiatives outside of their projects
You will need to have: - 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 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
We would prefer for you 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
Date Posted 12-Sep-2025
Closing Date 29-Sep-2025
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Job Tags
Full time,