Safety Surveillance Physician
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 results of data evaluation with the Surveillance Team and/or appropriate key partners, eg Senior PV Medical Director /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.
Provides medical input to regulatory supporting documentation for labelling updates.
Provides medical input to ensuring that risk-minimisation strategies are implemented appropriately in relevant documents such as product reference safety information
Provides input on cross-functional ad-hoc teams set up to address urgent and important safety issues
Regulatory Reports and Submissions
Provides medical input and review of periodic reports (e.g. PBRERs, PSURs, DSURs) and renewal documentation submitted to regulatory agencies.
Supports the maintenance of pharmacovigilance and Risk Management Planning (RMP) for designated established products, in partnership with the scientist as appropriate.
ESSENTIAL SKILLS REQUIRED
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.
Up to 2 to 4 years of Patient Safety experience (with clear evidence of delivery)
Total of 9 to 12 years of experience.
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