The Lead Surveillance Physician in association with more senior safety physician is responsible for continuous efficient evaluation of the adverse event and all other safety information in order to predict and manage the safety profile of marketed products through identifying the need for an update to reference safety information with global regulatory requirements with minimal supervision.
Responsible for medical review for aggregate regulatory documents, eg Periodic Benefit-Risk Evaluation Reports (PBRERs), ACO and (DSURs).
Proactively evaluates the clinical implications of safety data from pre-clinical studies, clinical studies, literature, and other information sources to predict / establish the safety profile of marketed compounds to manage the risk to patients with minimal supervision.
Understands the role of the QPPV and contributes to the maintenance of the pharmacovigilance system and processes.
The principal accountabilities/responsibilities for Safety Physician are summarized below. These may be in association with a senior physician as appropriate.
Signal Detection, Evaluation Risk Management activities, and Labelling
Involved in all safety surveillance activities, may include a medical review of individual safety cases (providing medical expertise and judgment), signal detection, evaluation and Safety Management Team activities for all established products in area of responsibility.
- Provides medical input into Identification and utilization of appropriate sources of information and database searches to retrieve relevant data for the evaluation of signals.
- Collaborates with external provider representatives in routine signal management activities.
- Discusses results of data evaluation with the Surveillance Team and/or appropriate key stakeholders, eg Senior PV Medical Director /Patient Safety VP TA, QPPV/Deputy QPPV.
- Provides medical input to deliver accurately 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.
- Provides medical input to regulatory supporting documentation for labeling updates
- Provides expertise to the medical content of the safety specification, pharmacovigilance plan, and risk minimization activities in the core PRMP globally reviewed LRMPs LRMPs for marketed products.
- Provides input on cross-functional ad-hoc teams set up to address urgent and important safety issues