Medical Director, Patient Safety Physician

Responsible for the Clinical Safety strategy for assigned AstraZeneca 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.

Responsible for the continued safetyassessment evaluation and risk management of AZ products or product groups in various stages of clinical development and/or the post-marketing setting.
Responsible for continuous efficient evaluation of adverse event and all other safety informationin order topredict and manage the safety profile of compounds in clinical development and marketed products throughidentifyingthe need for update to reference safety information and drive proactive implementation of risk management initiativesin accordance withglobal regulatory requirements.
Providesconsistent communication of safety topicsacrossallregulatorysafetydocumentseg.Periodic Benefit Risk Evaluation Reports (PBRERs) Periodic Adverse Drug Experience Reports (PADERs)andDevelopment Safety Update Reports(DSURs) for assigned product(s)/program(s).

Proactively evaluates 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 asSafety Knowledge Groups (SKGs) Safety Science Informatics expertise modeling and simulation to manage the risk to patients.

Works collaborativelywith experts from across AZ (e.g. Pre-clinical safety Safety Knowledge Groups Safety Informatics Scientists and Safety Science) as well as colleagues from all three Science Units as leader/member of a Safety Management Team)/ Safety Review Team or as a member of other cross-functional project teams thereby promoting high quality evaluation of safety data..

Understands the role of the QPPV and contributes to the maintenance of the pharmacovigilance system and processes.

Supportskey contacts with opinion leaders as needed.

The principalaccountabilities/responsibilitiesare summarized below.

Safety Governance and Risk Management activities

• Working with the Safety Teambe responsible forthe Clinical Safety strategy for assigned AstraZeneca 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.Activitiesinclude butarenot limited to: definition of identified and potential risks with high level mitigation and minimisation;proposals for mitigationminimisationmeasures;safetygo-nogo criteria for the clinical programme; input to TPP/TPC;ssafety submission strategies;response to regulatory safety queries and definition ofthe risk component of the benefit/risk assessment.

• Reviews and endorses the core Patient Risk Management Plan (PRMP)/Core Patient Risk Log (CPRL).

• Providesexpertiseto the medical content of the safety specification pharmacovigilanceplanand risk minimisation activities in the core PRMPdRMPCPRL and globally reviewed LRMPs.

• RepresentsPS 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 appropriately in relevant documents such as product reference safety information.

• Provides strategic clinical safety input into Clinical Development planning activitiesin accordance withPS 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 studyreportsand external data monitoring committees asappropriate.

• 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 ofa Safety Management Team/Safety ReviewTeamas necessary.

Signal Detection Evaluation and Labelling

Involved in all safety surveillance activities may include medical review of individual safety cases (providing medicalexpertiseand judgement) signal detectionevaluationand 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 andutilizationofappropriate sourcesof 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/orappropriate keystakeholdersegPatient Safety VP TA QPPV/Deputy QPPV.

• Provides medical input to deliveraccurateand fit for purpose safety evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data.

• Provides strategic input intoresponses toregulatory requests for local labeldeviations from the company core safety documentation.

• In consultationwith the PS scientist and Clinicalrepresentatives 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.

• Provides the patient safety contribution to global regulatory submissions (NDABLAMAA etc) for new products formulations or indications.

Other Activities
Contributes to and/or reviews the PS component of Safety Agreements

Advises on the preparation of licensing agreements in therapeutic area of responsibility. Participates in AZ internal meetings with project focus.

Participates in externalregulatory andnon-regulatory meetings including those with consultants and other companies such as licensing partners.

May assistin due diligence activities.

May provide support to AZLegal for product liability litigationasappropriate

Accountable for maintaining personal readiness in response to internal audit or regulatory inspection.

Participates in and may lead a process improvement initiative team within PS.

May contribute to advancement of methodology and process by generating new ideas and proposals for implementation.

Raises concerns/issues to senior management in a timely open and appropriate manner; ensures quality and integrity of issue/event being escalated.

May mentor and train juniormembers of the teamin signal evaluation methodology risk management and preparation of safety reports and otherdocuments.

Collaborateseffectively in cross-functional and cross-cultural project teams and environments and work with external providers.

Requirements Education and Experience

Essential

• Medical degree(eg MD MBBS)

• At least 2 years of clinical experience post-registration

• High level of medical competence with an ability to balance this with industry standards to achieve business goals

• Atleast2years of Drug Development/Patient Safety experience (the majority of which should be in industry in Patient Safety) with clear evidence of delivery

NB: It is not mandatory to meet the minimum requirements for length of experience or to have completed the UK Higher Medical Training in Pharmaceutical Medicine; these details are intended to be indicative of the level of knowledge expertise and recognition required of an individual in this job.

Desirable

• UK physicians will generally be expected to have completed Higher Medical Training in Pharmaceutical Medicine

• MSc/PhD in scientific discipline

• Able to work across TAs and Functions

• Experience of supervising Patient Safety colleagues

• A demonstrated ability to understand epidemiological data