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Pharmacovigilance- Drug Safety Associate or Scientist Jobs vacancies from TCS, Accenture, Wipro, IQVIA, Cognizant, Sciformix and etc

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Job Title: PV Coordinator

Company: Syneos Health Clinical Solutions

Qualification: B Pharm/ Pharmacy

Location: Asia Pacific - IND-Gurgaon-Cyber-City

Job Responsibilities: PV Coordinator

  • Monitors and routes incoming information to the appropriate project
  • Records all ICSR documentation and tracks in accordance with Sponsor/customer specifications; distributes incoming mail and faxes.
  • Redacts patient identifying information/ images in accordance with data protection guidelines, ICH GCP and GVP.
  • Enters data into the safety database in accordance with Sponsor/customer specific guidelines and Company standards.
  • Ensures current conventions are followed when entering cases into the Safety database.
  • Performs file creation, tracking, retention, and maintenance (paper and electronic).
  • Manages the translation process for any source documents requiring translation.
  • Performs or assist with query follow up process as instructed
  • Assists with submission processes as required
  • Assists with daily workflow reconciliation
  • Maintains understanding of Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, Good Pharmacovigilance Practice (GVP) modules, study/program plans and the drug development process.

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