Safety Physician TA Lead - Oncology

About the Company

Responsibilities

• ● Typical Accountabilities: Safety Governance and Risk Management Activities (30%)
• ● Be responsible for the development and implementation of China Clinical Safety strategy for assigned projects and products throughout all stages of development, and ensure CN alignment for Project Specific Safety Requirements (PSSR).
• ● Represents PS on cross-functional Clinical Teams and/or Project Teams for developmental and/or marketed products.
• ● Be responsible for the development of LRMPs, collaborate with MC PV physicians and key stakeholders to ensured aRMM/aPV aligned in final LRMPs
• ● 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.
• ● 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.
• ● Signal Detection, Evaluation and Labelling (10%)
• ● Collaborates with global PS in safety surveillance activities including but not limited to 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.
• ● Team leader (60%)
• ● Oversight of the full disease area product portfolio, and link with local management and key stakeholders.
• ● In responsible disease area, collaborate closely with China product teams and corresponding global patient safety teams, develop/implement relevant safety strategies to support product clinical development and lifecycle safety management.
• ● Accountable for mentoring, performance evaluation and career development of the team members.