R&D - PSPV - Associate PV Director - SH

1. Be responsible for safety risk management related to specify therapeutic areas (I & I) for product under development and marketed in CHINA

• Setting safety strategy of related TA products, i.e.

• • Provide and accumulate TA-specific PV expertise, contribute PV expert to support new launch.

  • Provide safety input to studies by reviewing study outline, protocol and CSR, etc. 

  • As medical reviewer for safety submission documents to health authority

    q  Develop and communicate monthly safety review report

  • Give PV input in due diligence for business development purpose

  • Help GSO to understand local regulation requirements.

  • Validate Chinese translation of EU RMP, DSUR, CSR, CCDS, Risk control plan, etc. for CTA and CTW/NDA.

  • Support to prepare slides and other submission dossier during CTA

  • Work out China risk management plan to specific products, and lead the cross-functional team to implement, manage the product safety risks in China market.

  • Serve as contact person, provide valuable inputs to partners from safety perspective (e.g. safety management plan) to support pipeline development and clinical study implementation.

• Implement and assessment as well as risk management to optimize benefit/risk profile of related products

• • Continuous and efficient evaluation of available safety information at local level

  • Drive proactive implementation of risk management in accordance with regulation requirement

  • Support CSH on signal detection in responsible TA and communicate the potential safety signal with GPV

  • Write local Periodic Safety Report if applicable.

• Management of safety related queries from external and internal stakeholders

• • Give PV input for regulatory related activities, e.g. labeling, license renewal, new application

  • Support CSH to response safety queries from HA, HCP and other external customers

  • Involved in various projects as PV expertise for responsible TA or products

  • Provide input on cross-functional ad-hoc teams set up to address urgent and important safety issues

2. Be responsible for business Development Project Management

• Lead pharmacovigilance workstream for China only business development initiatives including in-licensing, out-licensing, acquisitions, and strategic partnerships

• Coordinate comprehensive PV due diligence assessments for potential products, evaluating safety profiles, regulatory compliance status, and resource requirements as DD coordinator.

• Contribute and negotiate pharmacovigilance agreements (PVAs) and safety data exchange agreements (SDEAs) with business partners

• Coordinate cross-functional teams to ensure smooth transition of safety responsibilities and data during business transactions

• Establish and maintain relationships with PV counterparts at partner organizations