This is a PV Physician position, which needs you to lead projects independently.
Your new role
Be responsible for the Clinical Safety monitoring and management plan.
Reviews and endorses the core Patient Risk Management Plan/Core Patient Risk Log.
Provides expertise to the medical content of the safety specification, Pharmacovigilance plan and risk
Represents safety on cross-functional Clinical Teams and Project Teams for developmental and marketed products.
Provides medical input to ensuring that risk-minimisation strategies are implemented appropriately in relevant documents such as product reference safety information.
Provides strategic and medical input to project specific safety requirements. Reviews and provides technical input and approval for investigator brochures, protocols, informed consents, final study reports and external data monitoring committees as appropriate.
Present safety information at clinical investigator and commercial meetings.
Provides medical input to regulatory supporting documentation for labelling updates.
Provides medical input into Identification and utilisation of appropriate sources of information and database searches to retrieve relevant data for evaluation of signals.
Provides medical input to deliver accurate and fit for purpose safety evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data.
What you'll need to succeed
At least 2 years of clinical experience
At least 5 years of Drug Development experience with clear evidence of delivery
Drug Development Experience and Application of Disease and Disease knowledge
Excellence in Pharmacovigilance Patient Benefit risk assessment
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. #1221996
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)