This is a PV Operation position, which needs you to lead projects independently.
Your new role
Coordinating and supervising all PV activities in clinical trials to ensure regulatory compliance, including but not limited to PV vendor management, contributing to preparation and submission of expedited safety reports, supporting preparation and review of safety related documents.
Ensure collection and reporting of product safety events in post-marketing settings in good quality and in compliance with governing laws and legislations.
Coordinate preparation and submission of aggregated safety reports, DSUR, PUSR/PEBRE, etc.
Contribute to identification, evaluation and management of safety signals in collaboration with Safety Physician and other applicable functional specialists.
Contribute to the development of safety surveillance and risk management plans for drug development programs.
Support internal and external PV audits or inspection.
Perform PV trainings to relevant personnel according to the safety activities assigned.
Contribute in negotiations with business partners on Pharmacovigilance agreements; Interface with business partners as needed in accordance with applicable Pharmacovigilance agreements.
Support PV head on the PV capability establishment, including but not limited to the PV procedure and SOPs establishment, etc.
What you'll need to succeed
Bachelor's degree or above in life sciences, pharmacy, nursing or medical
Minimum 2 years experiences in safety operation
Familiar with PV processes and safety management in clinical study and post-marketing phase
Thorough understanding of the regulations and guidance applicable to PV
Experience in PV database management or audits/inspections is a plus
Excellent organizational skills, learning skills and ability to prioritise and multi-task
Excellent communication and interpersonal skills
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. #1221995
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)