Associate Director, Safety Scientist
Posted on Apr 5, 2021 by Alexion Pharmaceuticals
The Associate Director, Safety Scientist plays a leadership role within Global Drug Safety to actively evaluate and manage risk in collaboration with the GDS Medical Director and cross-functional team members within the global regulatory framework
Job Duties & Responsibilities
Represent global drug safety at regulatory inspections ie 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 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 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 on-going process enhancement for safety analytics and reporting, such as developing standard procedures and templates
Assist in 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
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
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