Associate Director, Safety Scientist, Gds
hace 4 semanas
**Associate Director, Safety Scientist Location**: Barcelona, SpainReporting to: Executive Medical Director Onsite with flexibility (2 days remote) This is what you will do: The Associate Director, Safety Scientist plays a leadership role within Global Drug Safety to actively evaluate and manage risk in collaboration with the GDS Medical Director and crossfunctional team members within the global regulatory framework You will be responsible for: Represent global drug safety at regulatory inspections i.e. MHRA, FDA, EMA, etc.Lead gap analysis to ensure alignment with changes in global regulationsManage safety scientist activities across multiple product portfolios and/or indicationsStrategizing and drafting of responses to regulatory inquiries on product safety issues inclusive of defining MedDRA search strategyParticipate in ongoing safety data review and analysis for products in designated therapeutic areas.Responsible for Signal Review Meeting and Signal Management Team activities in collaboration with GDS Medical DirectorsResponsible for project managing and authoring of safety documents including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requests in collaboration with safety physicians.Authors highquality aggregate safety reports to meet regulatory and internal deadlines; ensures all safety regulatory documents are processed and submitted according to regulatory requirementsResponsible for authoring safety section in collaboration with team members on regulatory responses, IBs/CCDS, protocol, ICF review, Data Monitoring Committees reports and requests, and other documents, and provide the necessary quality control to ensure alignment with core safety position. Manage a portfolio of products/projects related to risk management; assists GDS Medical Directors in the development of risk management strategy and activities for assigned productsAssists GDS Medical Directors to oversee risk minimization activities including tracking of activities as neededAssists in the evaluation of risk minimization activityAssist with responses to regulatory inquiries related to risk management plans under the guidance of GDS Medical Directors.Supports activities related to new drug applications and other regulatory filingsContribute to ongoing process enhancement for safety analytics and reporting, such as developing standard procedures and templatesAssist in the review of Individual Case Safety Report (ICSR) and analysis of similar events (AOSE) as necessaryManage, train and/or support junior safety scientists and fellowsMay 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 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 preand postmarketingExperience with Risk Management and Minimization programsExperience preparing postmarketing safety regulatory documents including PSURs, PBRERs, and Risk Management PlansExperience with clinical development including risk/benefit analysis and safety assessmentStrong analytical, problemsolving 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 Excel 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 strategies
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Associate Director, Safety Scientist, Gds
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Barcelona, España Alexion Pharmaceuticals,Inc. A tiempo completoSome opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and...
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Barcelona, Barcelona, España AstraZeneca A tiempo completoAt AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe.Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal...
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Barcelona, Barcelona, España AstraZeneca A tiempo completoRole:Associate Director, Senior Patient Safety Scientist**At AstraZeneca, we work together to deliver innovative medicines to patients across global boundaries. We make an impact and find solutions to challenges. We do this with integrity, even in the most difficult situations, because we are committed to doing the right thing.This is an opportunity to...
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