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Careers
Position: PV Physician (Director/AD/Sr Manager)
Location: Shanghai/Beijing, China
Report Line: PV Head

Job Summary

This role is to take primary responsibility for clinical safety and risk management. Maintain an environment of strict compliance standards. Promote and ensure full adherence as well as applicable worldwide health authority regulation.

Key Responsibilities

Responsible for ensuring capabilities are in place to perform safety physician activities including but not limited to:

•Be responsible for the implementation of the Clinical Safety strategy for assigned projects and products throughout all stages of development, including implementation and communication of the strategy at the project team/governance level.

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

•Collaborate with clinical physicians and key stakeholders to ensured the development of RCP

•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.

•Provides strategic and medical input to project specific safety requirements.

•Reviews and provides technical input and approval for protocols, informed consents, clinical study reports and safety relevant content of clinical technical documents as appropriate.

•Sets strategic direction for addressing safety issues in regulatory submission and communication/interaction

•Provides input on cross-functional ad-hoc teams set up to address urgent and important safety issues.

•May present safety information at clinical investigator meetings.

•Provides medical review of ICSR, signal detection and evaluation , activities relevant to Safety Information Review Committee (SIRC);

•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 in routine signal management activities.

•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.


Requirements

•Medical or Life Science degree

•5+ years of experience in PV area from international Pharmacovigilance environment

•Experience with PV databases and systems admin

•Proficient in regulatory guidance and legislation

•Fluency in English