Safety Physician TA Lead - Oncology

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.
• Monitor and forecast team workload to identify, mitigate and escalate potential resource and non-compliance issues.
• Support the head of safety science team to develop necessary processes and procedures to ensure compliance and efficiency.
• Support the head of safety science team to collaborate with local and global relevant teams for the update and review of safety related SOPs/guidelines to ensure the compliance with company policies and requirements of health authority.

Education, Qualifications, Skills and Experience

• Medical background
• At least 10 years of Drug Development/Patient Safety experience in MNC
• Strong people management and leadership capabilities
• Adequate understanding of the China and global regulations/guidances in order to have effective oversight of R&D China safety monitoring process
• Drug development experience and good understanding of Clinical Study Process
• Good medical knowledge in AZ Therapeutic Areas.
• Excellence in pharmacovigilance and Patient Benefit risk assessment
• Good organizational skills with the ability to multi-task and prioritize assignments (planning and organizing)
• Fluent in written and spoken English

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.