Medical Safety Lead, TDC, Shanghai [China]

 

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Job Description

OBJECTIVE:

• Local medical safety lead is the local medical safety expert for compound(s) both in clinical development and marketed in China, working in close collaboration with the Global GSL(s) and is responsible for conducting medical safety relevant tasks in order to safeguard patient safety.
• Provide product knowledge with focus on safety profiles, Therapeutic Area and Disease Pathway knowledge supporting the needs of the China BU (MA, BU, Access) for post-approval and TDC Asia (Clin Science and PV operation for pre-approval, etc.).
• Contribute to the scientific analysis and review of safety data from of various sources (eg, regulatory, clinical, submission, legal, product quality) using knowledge of the regulations.
• In partnership with Head of PVAR China, Global GSL and respective TAH, defines and implements the local PV strategies as appropriate.
• In collaboration with R&D cross-functions in TDC-Asia and China BU to support pre-marketing and post-marketing PV related activities.
• Collaborate and liaise with Head of PVAR China and other GPSE functions to ensure appropriate systems/processes are in place to support the local PV system.
• Manage the PV relationship within the Local Operating Company (LOC) to provide best Pharmacovigilance (PV) support and functional expertise to the LOC.
• Ensure compliance to applicable local legislations, company standards and procedures.

ACCOUNTABILITIES:

IND(CTA)/NDA Registration

• Provide safety input of regulatory submission dossier for CTA and NDA registration.
• Prepare required safety related document(s) for CTA and NDA registration.
• Set strategic direction for addressing safety issues in regulatory submission and communication/interaction.
• Collaborate with GSL(s) and SWG (submission working group) on CTA and NDA registration.

Study Review

• 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).
• Perform safety expert to local/global studies for safety related matters when required.

Safety Expert Inputs

• Review and provide safety inputs for safety related documents (DSUR, PBRER, RMP, PI, or other safety-related documents), as per local regulation/local health authority requirement for assigned products (IB, protocols, RMP, labelling), as appropriate.
• Provide inputs on cross-functional ad-hoc teams set up to address urgent and important safety issues. Like, participate in and facilitate the China local compensation issue discussion, as appropriate.
• Manage and oversee the identification of risks and prioritizes the mitigation actions that impacts value of patients.
• Monitor the implementation of RMP in local. Provide guidance and implementation of additional risk minimization materials (aRMM) to ensure local relevant colleagues have a clear idea on aRMM and promise to support PV to implement aRMM in China.
• Support local PV team on global/local authority required safety related documents.
• Conduct local safety signal detection or signal management activities, as appropriate.

Safety Communication

• Ensure that new safety information is available to HA and Healthcare Professionals (HCPs) in a timely manner, i.e. Direct Healthcare Professional Communication (DHPC), company core datasheet (CCDS) implementation into local label if applicable.
• Involve in DHPCs management, submit and track DHPCs to HAs/HCPs, as applicable.
• Provide strategic safety-related regulatory communication (e.g., response to request for information from local HA, including the provision of information about the volume of sales or prescription, as appropriate), as applicable.
• Support LOC stakeholders to communicate 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 concepts of special interest, as appropriate.

Audit & Inspection Readiness

• Act as one of the local PV contact persons for local PV audits and inspection and coordinate the audit and inspection preparations.

Locations

Shanghai, China

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

 

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