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Job Description

Objective / Purpose:

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 safetyProvide 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 activitiesContribute to scientific analysis and review of safety data from of various sources (e.g., regulatory, clinical, submission, legal, product quality) by utilizing local regulatory expertiseDefine 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 activitiesWork closely with the Head of PSPV-AM China and other PV functions to establish and maintain effective systems and processes supporting the local PV systemManage the PV relationship within the Local Operating Company (LOC) to provide optimal PV support and functional expertiseEnsure compliance to applicable local legislations, company standards and procedures

Accountabilities:

IND(CTA)/NDA Support

Provide safety input of regulatory submission dossierPrepare 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 documentsPresent safety information and input at clinical investigator meetings, as appropriatePerform 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 regulationsParticipate in cross-functional ad-hoc teams to address urgent safety issuesSupport risk identification and prioritize mitigation actions impacting patient valueMonitor RMP implementation locally and provide guidance on aRMM to stakeholders to ensure the execution.Support local PV team on global/local authority-required safety documentsConduct 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 applicableContribute to DHPCs management, submit and track DHPCs to HAs/HCPs, as applicableProvide strategic safety-related regulatory communication (e.g., response to local regulatory queries), as applicableSupport 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 experienceWith at least 5 years in clinical and/or medical safety experiencePrior experience with CTA/NDA/BLA or equivalent regulatory submissions, or experience working in a Regulatory Agency reviewing submission fileIndustry experience in clinical research and/or clinical drug safety (post-marketing pharmacovigilance and/or clinical development) would be an advantageGood global player in a global PV organizationExcellent communication and presentational skills with counterparts such as relevant department, regulatory agency and global relevant teamKnowledge with clinical trial methodology, pharmacovigilance regulations, safety profile and risk/benefit analysisFamiliar with the relevant regulatory guidelines of NMPA, ICH and major international regulatory authorities such as FDAAbility to review, analyze, interpret and present complex data to a high standardDecision making capability, and ability to independently resolve problems and conflicts

LocationsCHN - Shanghai - Research and Development

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time