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-fu...