Your new role
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.

What you'll need to succeed
Medical Doctor, Pharmacist, Health Sciences PhD, MPh or Master Degree with three or more years of pharmacovigilance/clinical development experience.
Experience with pharmacovigilance systems and safety related product management in both clinical development and marketed products,
Appropriate experience with Regulatory Agency interactions
Knowledge of regulatory requirements for drug safety in China
The country Safety Risk Management manager must demonstrate proficiency in English (verbal and written)

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career. #1228242


Job Type
Life Sciences

Talk to a consultant

Talk to Lunah Wang, the specialist consultant managing this position, located in Shanghai
Unit 1205-1212, HKRI Centre One, HKRI Taikoo Hui, 288 Shimen Road (No.1)


Similar jobs to PVP

  • PVP AD

    This is a PV Physician position, which needs you to lead projects independently.