Senior Safety Physician Oncology

Job Description

Location: Cambridge Competitive Salary & BenefitsAt AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s outstanding skills with those of people from all over the globe.We focus on advancing the science of oncology to deliver life-changing medicines to patients with a pipeline that exploits the power of six scientific platforms (Tumour Drivers and Resistance, DNA Damage Response, Immuno-Oncology, Antibody-Drug Conjugates, Epigenetics and Cell Therapy).We currently have nearly 100 Phase 1, 2, 3 and Lifecycle Management Oncology projects in our robust pipeline.We have an exciting opportunity for a Senior Patient Safety Physician - Oncology to join our team in Cambridge, UK. The role will be based in our Central Cambridge City House offices, close to Cambridge Train Station.In this role, you will be responsible for the Clinical Safety strategy for assigned drug projects and products throughout all stages of development and/or when on the market, including implementation and communication of the strategy at the project team/governance level.You will focus on continued safety assessment, evaluation and risk management of AZ products or product groups in various stages of clinical development and/or the post-marketing setting.You are responsible for continuous efficient evaluation of adverse event and all other safety information in order to predict and manage the safety profile of compounds in clinical development and marketed products through identifying the need for update to reference safety information and drive proactive implementation of risk management initiatives in accordance with global regulatory requirements.You will communicate consistently on safety topics across all regulatory safety documents, eg Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), and Development Safety Update Reports (DSURs). for assigned product(s)/programs(s).You will also proactively evaluate the clinical implications of safety data from pre-clinical studies, clinical studies, literature and other information sources in order to predict / establish the safety profile of compounds in clinical development, including employing expert groups and methodologies such as Safety Knowledge Groups (SKG’s), Safety Science, Informatics expertise, modelling and simulation to manage the risk to patients.You will work collaboratively with experts from across AZ (e.g. Pre-clinical safety, SKGs, Safety Informatics Scientists and Safety Science) or as a member of other cross-functional project teams, thereby promoting high quality evaluation of safety data.You will understand the role of the QPPV and contributes to the maintenance of the pharmacovigilance system and processes.You will support key contacts with opinion leaders, as needed. Safety Governance and Risk Management activities Activities include, but are not limited to: definition of identified and potential risks, proposals for mitigation and minimisation measures,, safety go-no-go criteria for the clinical programme, input to TPP/TPC,, safety submission strategies, response to regulatory safety queries and definition of risk component of the benefit/risk assessmentReviews and endorses the core Patient Risk Management Plan (PRMP)/Core Patient Risk Log (CPRL).Provides expertise to the medical content of the safety specification, pharmacovigilance plan and risk minimisation activities in the core PRMP,, CPRL and globally reviewed LRMPs.Represents PS on cross-functional Clinical Teams and/or Project Teams for developmental and/or marketed products.Leads medical input to ensuring that risk-minimisation strategies are implemented appropriately in relevant documents such as product reference safety information.Leads strategic clinical safety input into Clinical Development planning activities in accordance with PS Operating Model and Science Unit Service Level agreements.Leads 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/MedImmune Safety Review Team as necessary. Signal Detection, Evaluation and Labelling Involved in all safety surveillance activities, may include medical review of individual safety cases (providing medical expertise and judgement), signal detection, evaluation and SERM activities (or Medimmune equivalent) for all products in area or responsibility.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.Sets the strategy for routine signal management activities.Presents the results of data evaluation with the Surveillance Team and/or appropriate key business partners, 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 documentationIn consultation with the PS scientist and Clinical representatives, prepares the Developmental Core Safety Information (DCSI) for assigned development products. Regulatory Reports and Submissions Provides medical input and review of periodic reports (eg PBRERs, PSURs, DSURs) and renewal documentation submitted to regulatory agencies.Leads the patient safety contribution to global regulatory submissions (NDA, BLA, MAA etc) for new products, formulations or indications. Essential Requirements