Job Description
Serve as the local medical safety lead, acting as the expert for compounds in both clinical development and marketed in China. Collaborate closely with Global Safety Leads (GSLs) to execute medical safety tasks and ensure patient safety.
About This Role
* 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 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).
Responsibilities
* 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.
* Safety Expert Inputs: Review safety-related documents (DSUR, PBRER, IB, protocols, RMP, PI, etc.) in compliance with local regulations.
* Safety Communication: Ensure the availability of new safety information to HA and Healthcare Professionals (HCPs) in a timely manner through Direct Healthcare Professional Communication (DHPC), Company Core Datasheet (CCDS) implementation into local label if applicable.
Requirements
* Clinical physician with clinical experience.
* 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.
Audiitorium - Shanghai - Research and Development
Full Time Employee Opportunity