Associate Director, Safety Scientist, Global Patient Safety

hace 6 días

España AstraZeneca GmbH A tiempo completo

This is what you will do: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 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 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 providing the necessary quality control to ensure alignment with core safety position.Managing portfolio of products/projects related to risk management; assisting GPS Medical Directors in the development of risk management strategy and activities for assigned products.Contributing to ongoing 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: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 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.AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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