PV Manager
1. Responsible for the receipt, processing, reporting and follow-up of individual safety reports from clinical trial sources. Ensure that the reported information is accurate, and submit it to domestic and foreign regulatory authorities within the time limit required by regulations
2. Maintain and update product safety-related documents as required; write pharmacovigilance related work procedures and specifications
3. Write training materials, arrange pharmacovigilance knowledge training for relevant personnel of the company, and archive and maintain training records
4. Participate in internal and external drug safety audits
5. Lead the analysis and identification, investigation and evaluation of individual adverse drug reactions/events
1. Bachelor degree or above, major in medicine and pharmacy or biomedicine
2. Master the relevant laws and regulations of pharmacovigilance, national requirements for monitoring and reporting of adverse drug reactions, and domestic and foreign PV inspection requirements, etc.
3. 5+ years pharmacovigilance related work experience
4. Proficiency in using ARGUS software