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

1. 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.

2. 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.

3. 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