This is what you will do:The Associate Director, Safety Scientistplays 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 framework.You will be responsible for:Managing safety scientist activities across multiple product portfolios and/or indications.Organizing, training and/or supporting junior safety scientists and fellows.Supporting activities related to new drug applications and other regulatory filings.Representing global patient safety at regulatory inspections e.g., MHRA, FDA, EMA, etc.Leading gap analysis to ensure alignment with changes in global regulations.Strategizing and drafting of responses to regulatory inquiries on product safety issues inclusive of defining MedDRA search strategy.Representing GPS in global program teams and associated cross functional teams and/or projects as needed.Proactively providing guidance and educational training to GPS therapeutic teams.Responsible for Signal Review Meeting and Signal Management Team activities in collaboration with GPS Medical Directors.Performing Signal Surveillance activities for respective programs in collaboration with GPS Medical Directors.Project managing and authoring safety documents including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requests in collaboration with GPS Medical Directors.Authoring 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 products.Contribute to on-going process enhancement for safety analytics and reporting, such as developing standard procedures and templates.Assisting GPS Medical Directors to oversee risk minimization activities including tracking of activities as needed.May be directed by the line function to support initiatives outside of their projects.You will need to have:Bachelors 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 clinical, 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.The 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 PhD.Expertise with clinical and safety databases.Experience in MedDRA coding and search strategies.Excellent, independent judgment based on knowledge and expertise.Strong personal time-management and project-management skills.Mastery of Microsoft Word, PowerPoint and Excel.Date Posted: 21-oct-2024Closing Date:Alexion 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.
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