Job Opportunities

PV Operation Manager or Director

Department: PV
Job Title: PV Operation Manager or Director
Report to: PV Senior Director
Location: China

MAIN REPONSIBILITIES:

  • 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

QUALIFICATIONS:

  • 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.