Medical Director, Patient Safety Physician

The Medical Director, Patient Safety Physician is responsible for the Clinical Safety strategy for assigned AstraZeneca-MedImmune drug projects and products throughout all stages of development and/or when on the market. This includes the implementation and communication of the strategy at the project team/governance level. You will ensure the 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. Your role will involve continuous efficient evaluation of adverse events and all other safety information to predict and manage the safety profile of compounds in clinical development and marketed products. You will also provide consistent communication of safety topics across all regulatory safety documents and proactively evaluate the clinical implications of safety data from various sources to establish the safety profile of compounds in clinical development.

Safety Governance and Risk Management activities

• Working with the Safety Team, be responsible for the Clinical Safety strategy for assigned AstraZeneca-MedImmune 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.

• Reviews 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 minimization activities.

• Represents PS on cross-functional Clinical Teams and/or Project Teams for developmental and/or marketed products.

• Provides medical input to ensuring that risk-minimization strategies are implemented appropriately in relevant documents such as 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.

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.

• 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.

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 (NDA, BLA, MAA etc) for new products, formulations or indications.

Essential Skills/Experience

• Medical degree (MD, MBBS)

• Minimum of 3 years of clinical experience

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

• 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 discipline

• Able to work across Therapy Areas and Functions

• Experience supervising Patient Safety colleagues

• A demonstrated ability to understand epidemiological data