TRANSCENTA HOLDING - A global Fully Integrated Biotherapeutics Company

Transcenta, biologics, antibody

TRANSCENTA HOLDING - A global Fully Integrated Biotherapeutics Company

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PV Manager

Department :  CD&RA
Working place :  Beijing
Recruitment :  1
Nature of work :  Full-Time
Working years of :  5+ years experience
Minimum academic :  Bachelor
Release time :  08 Jul, 2021
Job Responsibilities
  • 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

Job Requirements
  • 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