Associate Director, Safety Scientist, Global Patient Safety

Job title:

Associate Director, Safety Scientist, Global Patient Safety

Company:

Alexion Pharmaceuticals

Job description

Location: Barcelona, Spain (on-site) 3 days working from the office.The Associate Director, Safety Scientist plays a leadership role within Global Patient Safety (GPS) to actively evaluate and manage risk in collaboration with the GPS Medical Director(s) and cross-functional team members within the global regulatory frameworkYou will be responsible for:Managing safety scientist activities across multiple product portfolios and/or indicationsOrganizing, training and/or supporting junior safety scientists and fellowsSupporting activities related to new drug applications and other regulatory filingsRepresenting global patient safety at regulatory inspections e.g., MHRA, FDA, EMA, etc.Leading gap analysis to ensure alignment with changes in global regulationsStrategizing and drafting of responses to regulatory inquiries on product safety issues inclusive of defining MedDRA search strategyPresenting GPS in global program teams and associated cross functional teams and/or projects as neededProactively providing guidance and educational training to GPS therapeutic teamsParticipating in ongoing safety data review and analysis for products in designated therapeutic areas.Performing Signal Surviellance activities for respective programs in collaboration with GPS Medical DirectorsProject managing and authoring of safety documents including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requests in collaboration with GPS Medical DirectorsAuthoring safety sections, in collaboration with team members, on regulatory responses, IBs/CCDS, protocols, ICFs, Data Monitoring Committee 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 GPS Medical Directors in the development of risk management strategy and activities for assigned productsContribute to on-going process enhancement for safety analytics and reporting, such as developing standard procedures and templatesAssisting GDS Medical Directors to oversee risk minimization activities including tracking of activities as neededMay be directed by the line function to support initiatives outside of their projectsYou will need to have:Bachelors degree in a biologic/medical/clinical/nursing fieldAt least 5 years experience in drug safety and risk management within the pharmaceutical, biotech or CRO industryKnowledge and understanding of US and EU safety regulations pre- and post- marketingExperience with Risk Management and Minimization programsExperience preparing post marketing safety regulatory documents including PSURs, PBRERs and Risk Management PlansExperience with clinical development including risk/benefit analysis and safety assessmentStrong clinical, analytical, problem solving and scientific writing and communication skillsAbility to interact effectively with people of multiple disciplines and cultures both within and outside the company on a global basisExpertise with Microsoft Word, PowerPoint, SharePoint and ExcelThe duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.We would prefer for you to have:Advanced degree in a biologic/medical/clinical/nursing field preferred: Pharmacist/PharmD, Nurse Practitioner or PhDExpertise with clinical and safety databasesExperience in MedDRA coding and search strategiesExcellent, independent judgment based on knowledge and expertiseStrong personal time-management and project-management skillsMastery of Microsoft Word, PowerPoint and ExcelDate Posted 01-jul-2025Closing Date 30-jul-2025Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact . Alexion participates in E-Verify.

Expected salary

Location

Barcelona

Job date

Wed, 02 Jul 2025 22:35:28 GMT

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