PV Operation Manager or Director
Job Title: PV Operation Manager or Director
Report to: PV Senior Director
- Supervision and management of collection, processing, documentation, reviewing, reporting and follow-up of all adverse event reports for products from clinical trials, non-interventional studies, literature, Spontaneous Reports, etc.
- Manage reporting/submission/distribution of safety reports/updates/information (e.g., SAE, SR, SUSAR,) to Local Health Authorities and/or clinical operations
- Managing all safety operation activities in clinical trial globally, including trial safety operation related documents preparation, trial study start-up, trial safety operation training, query management, SAE reconciliation, support trial data clean activities, trial closure activities and global inspection readiness to ensure trial safety operations are continuously met
- Protocol and ICF review, to ensure compliance with the pharmacovigilance requirements.
- To prepare the DSUR and PSUR/PBRER in collaboration with PV lead, and other functional team and send it to the HA according to the pharmacovigilance regulatory requirements
- Oversight outsourcing PV activities including training, oversight monitoring, performance metrics review of vendor activities
- Assist in the development of department-specific SOPs and Work Instructions
- At least 5 years of drug safety operation experience in pharmaceutical company
- Knowledge of China, US and EU’s regulations for pharmacovigilance
- Knowledge of pharmacological and medical terminology
- Experience working with Argus, EDC and MedDRA coding dictionary
- Good team player and excellent communications, interpersonal skills
- Medical, biology, pharmacology, or healthcare related bachelor’s degree, or above
- Fluent in both written and spoken English and Chinese
- Computer literacy; MS Office suite, Excel, PowerPoint, etc.