Location: Barcelona, Spain
Job reference: R-211271
Date posted: 10/21/2024
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 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)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 strategyRepresenting GPS in global program teams and associated cross-functional teams and/or projects as neededProactively providing guidance and educational training to GPS therapeutic teamsResponsible for Signal Review Meeting and Signal Management Team activities in collaboration with GPS Medical DirectorsPerforming Signal Surveillance 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 positionManage 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 ongoing process enhancement for safety analytics and reporting, such as developing standard procedures and templatesAssisting GPS 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:Bachelor's 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 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/Pharm D, 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 ExcelAstraZeneca 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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