Pharmacovigilance Operations


The PV Operations include Case Management, Alliance and Vendor Management, and Quality and Document Management. Individual have to manage the operation infrastructure required to oversee all aspects of adverse event collection, processing, and reporting from clinical trials. Responsible for development and preparation of the safety sections of protocols, investigator brochures, clinical study reports, and other documents to ensure that the documents are appropriate, feasible, operational and accurately reflect the safety and/or risk-benefit profile.



 


  • Pharmacovigilance outsourcing
  • Standard operating procedures
  • Post-marketing case processing

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