Job Description
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.
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.