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Global Patient Safety Physician
hace 2 semanas
Location: Barcelona, Spain (3 days/week working from the office) Join us at AstraZeneca in the Vaccines and Immune Therapies therapeutic area as a Global Patient Safety Physician. This roleروب...we need your expertise to help us turn our ambition into a reality.We are at an exciting frontier of medicine, and we need your expertise to help us turn our ambition into a reality. Main responsibilities: Working with transportation Provides expertise to the medical content of the safety specification, pharmacovigilance plan and risk minimisation activities in the core PRMP, dRMP, CPRL and globally reviewed LRMPs. Represents PS on cross-functional Clinical Teams and/or Project Teams for developmental and/or marketed products. Provides medical input to ensuring that risk‑minimisation strategies are implemented.Beginning in relevant documents such as the product reference safety information. Provides strategic clinical safety input into Clinical Development planning activities in accordance with PS Operating Model and Science Unit Service Level agreements. Provides strategic and medical input to project specific safety requirements (PSSR). Reviews and provides technical input and approval for investigator brochures, protocols, informed consents, final study reports and external data monitoring committees as appropriate. Provides input on cross-functional ad‑hoc teams set up to address urgent and important safety issues. May present safety information at clinical investigator and commercial meetings. Facilitates establishment of a Safety Management Team as necessary. Provides medical input to regulatory supporting documentation for labelling updates. Provides medical input into Identification and utilization of appropriate sources of information and database searches to retrieve relevant data for evaluation of signals. Collaborates with external provider representatives in routine signal management activities. Discusses the results of data evaluation with the Surveillance Team and/or appropriate key stakeholders, eg Patient Safety VP TA, QPPV/Deputy QPPV. Provides medical input to deliver accurate and fit for purpose safety evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data. Provides strategic input into responses to regulatory requests for local label deviations from the company core safety documentation. In consultation with the PS scientist and Clinical representatives, prepares the Developmental Core Safety Information (DCSI) for assigned development products. Provides medical input and review of periodic reports (eg PBRERs, PSURs, DSURs) and renewal documentation submitted to regulatory agencies. Provides the patient safety contribution to global regulatory submissions (NDA, BLA, MAA etc) for new products, formulations or indications. Essential Skills/Experience: Medical degree (eg MD, MBBS) At least 2 years of clinical experience post-registration High level of medical competence At least 2 years of Drug Development/Patient Safety experience (the majority of which should be in industry in Patient Safety) with clear evidence of delivery Desirable Skills/Experience: MSc/PhD in scientific死亡discipline Able to work across TAs and Functions Experience of supervising Patient Safety colleagues A demonstrated ability to understand epidemiological data When we put unexpected teams in theεπSame room, we unleash boldatek... At AstraZeneca, we are changemakers on the world stage. We are helping to transform healthcare and build pandemic preparedness to protect against future health crises. Join us and be a part of the excitement and success of a global team with the brightest minds. Here you will find a dynamic community where diversity is our strength... Are you ready to make a meaningful and lasting difference? Apply now Date Posted 14-Jan-2026 Closing Date 15-Jan-2026 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. קללועWe 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. #J-18808-Ljbffr
