Associate Director, Safety ScientistLocation: Barcelona, SpainReporting to: Executive Medical DirectorOnsite with flexibility (2 days remote)This is what you will do: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.You will be responsible for:Representing global drug safety at regulatory inspections (i.e., MHRA, FDA, EMA, etc.).Leading gap analysis to ensure alignment with changes in global regulations.Managing safety scientist activities across multiple product portfolios and/or indications.Strategizing and drafting responses to regulatory inquiries on product safety issues, including defining MedDRA search strategy.Participating in ongoing safety data review and analysis for products in designated therapeutic areas.Managing Signal Review Meeting and Signal Management Team activities in collaboration with GDS Medical Directors.Project managing and authoring safety documents including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requests in collaboration with 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 sections in collaboration with team members on regulatory responses, IBs/CCDS, protocol, ICF review, Data Monitoring Committees reports and requests, and other documents, providing necessary quality control to ensure alignment with core safety position.Managing a portfolio of products/projects related to risk management; assisting GDS Medical Directors in the development of risk management strategy and activities for assigned products.Assisting GDS Medical Directors to oversee risk minimization activities, including tracking of activities as needed.Assisting in the evaluation of risk minimization activity.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 ongoing process enhancement for safety analytics and reporting, such as developing standard procedures and templates.Assisting in the review of Individual Case Safety Report (ICSR) and analysis of similar events (AOSE) as necessary.Managing, training and/or supporting 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, 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.
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