R&D- PSPV - Senior PV Manager - SH

Role Summary

Be responsible for safety risk management related to specified therapeutic areas (I & I) for products under development and marketed in China.

Responsibilities

• 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
• 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