- Serve as the local medical safety lead, acting as the expert for compounds in both clinical development and marketed in China, collaborating closely with Global Safety Leads (GSLs) to execute medical safety tasks and ensure patient safety - Provide product knowledge focusing on safety profiles, therapeutic areas and disease pathways to support the China BU (MA, BU, Access) for post-approval activities and TDC Asia (Clinical Science and PV operation) for pre-approval activities - Contribute to scientific analysis and review of safety data from of various sources (e.g., regulatory, clinical, submission, legal, product quality) by utilizing local regulatory expertise - Define and implement local pharmacovigilance (PV) strategies in collaboration with the Head of PSPV-AM China, Global GSL, and respective Therapeutic Area Heads (TAH) - Collaborate with R&D cross-functions in TDC-Asia and China BU to support premarketing and post-marketing PV activities - Work closely with the Head of PSPV-AM China and other PV functions to establish and maintain effective systems and processes supporting the local PV system - Manage the PV relationship within the Local Operating Company (LOC) to provide optimal PV support and functional expertise - Ensure compliance to applicable local legislations, company standards and procedures
Accountabilities:
IND(CTA)/NDA Support - Provide safety input of regulatory submission dossier - Prepare required safety related document(s) - Set strategic direction for addressing safety issues in regulatory submission and communication/interaction. - Work closely with GSL(s) and SWG (submission working group) on CTA and NDA registration
Clinical Study Support - Provide input into safety sections of local/global study proposal, protocols, informed consents, or study reports (including pre-marketing clinical trials by TDC Asia, local sponsored studies, IITs, CRs) reports and safety relevant content of clinical technical documents - Present safety information and input at clinical investigator meetings, as appropriate - Perform concept and protocol review related to data generation activities - clinical and post-marketing studies and local Safety Monitoring Plan (SMP) - Serve as the local safety expert to local/global studies for safety related matters when required
Safety Expert Inputs - Review safety-related documents (DSUR, PBRER, IB, protocols, RMP, PI, etc.) in compliance with local regulations - Participate in cross-functional ad-hoc teams to address urgent safety issues - Support risk identification and prioritize mitigation actions impacting patient value - Monitor RMP implementation locally and provide guidance on aRMM to stakeholders to ensure the execution. - Support local PV team on global/local authority-required safety documents - Conduct local safety signal detection and management activities as necessary Safety Communication - Ensure the availability of new safety information to HA and Healthcare Professionals (HCPs) in a timely manner through, i.e. Direct Healthcare Professional Communication (DHPC), Company Core Datasheet (CCDS) implementation into local label if applicable - Contribute to DHPCs management, submit and track DHPCs to HAs/HCPs, as applicable - Provide strategic safety-related regulatory communication (e.g., response to local regulatory queries), as applicable - Support LOC stakeholders in communicating with HCPs on safety related inquiries as appropriate
Safety Training/Sharing Support - Perform PV training/sharing for LOC employees, covering safety aspects of products and follow-up process for safety concepts of special interest, as appropriate
Audit & Inspection Readiness - Act as a local safety SME for local PV audits/inspection and support the preparations Education & Competencies (Technical and Behavioral):
- Clinical physician with clinical experience - With at least 5 years in clinical and/or medical safety experience - Prior experience with CTA/NDA/BLA or equivalent regulatory submissions, or experience working in a Regulatory Agency reviewing submission file - Industry experience in clinical research and/or clinical drug safety (post-marketing pharmacovigilance and/or clinical development) would be an advantage - Good global player in a global PV organization - Excellent communication and presentational skills with counterparts such as relevant department, regulatory agency and global relevant team - Knowledge with clinical trial methodology, pharmacovigilance regulations, safety profile and risk/benefit analysis - Familiar with the relevant regulatory guidelines of NMPA, ICH and major international regulatory authorities such as FDA - Ability to review, analyze, interpret and present complex data to a high standard - Decision making capability, and ability to independently resolve problems and conflicts
