Location: Barcelona, Spain
Job reference: R-208727
Date posted: 09/11/2024
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 of responses to regulatory inquiries on product safety issues inclusive of defining MedDRA search strategy. Presenting 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. Participating in ongoing safety data review and analysis for products in designated therapeutic areas. Performing Signal Surveillance activities for respective programs in collaboration with GPS Medical Directors. Project managing and authoring of 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 ongoing process enhancement for safety analytics and reporting, such as developing standard procedures and templates. Assisting GDS 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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