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Medical Director, Patient Safety Physician
hace 2 semanas
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, including implementation and communication of the strategy at the project team/governance level.
Responsible for 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.
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.
Provides consistent communication of 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)/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 as Safety Knowledge Groups (SKG’s), Safety Science, Informatics expertise, modeling and simulation to manage the risk to patients.
Works collaboratively with experts from across AZ-MedImmune (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)/ MedImmune 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.
Supports key contacts with opinion leaders, as needed.
The principal accountabilities/responsibilities are summarized below.
**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. Activities include, but are not limited to: definition of identified and potential risks with high level mitigation and minimisation; proposals for mitigation minimisation measures; safety go-no go criteria for the clinical programme; input to TPP/TPC; s safety submission strategies; response to regulatory safety queries and definition of the risk component of the benefit/risk assessment.
- 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 minimisation activities in the core PRMP, MedImmune 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 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.
- 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.
- Collaborates with external provider representatives in routine signal management activities.
- Discuss
