Safety Case Coordinator

17 hours ago

Udaipur, Rajasthan, India beBeeDataOfficer Full time US$ 70,000 - US$ 98,000

Job Opportunity:

Are you a detail-oriented and organized individual with a passion for pharmacovigilance?

The ProductLife Group is seeking a dynamic Pharmacovigilance Data Officer to join our team in the Hub.

Key Responsibilities:

  • Perform local safety case receipt, processing and data entry, quality control (QC) tracking and ICSR follow-up of all safety information received for clients
  • Manage generic or client-specific email boxes as required
  • Register, triage, assign and coordinate for the processing of vigilance cases
  • Follow-up requests with local reporters
  • Respond to queries from clients and reporters
  • Conduct periodic reconciliations to confirm proper handling of all vigilance reports for clients
  • Support local pharmacovigilance activities as needed
  • Participate in audits/inspections and resulting action plans

Requirements:

  • Bachelor's or Master's degree in Medicine, Pharmacy, Nursing, or Science related field, or equivalent experience
  • 2+ years' experience in pharmacovigilance, including data entry and QC of cases
  • Previous experience working to deadlines and meeting targets
  • Strong knowledge of US and EU PV regulations, pharmaceutical background, and GVP, GCP, FDA and regulatory requirements
  • Excellent communication, organizational, and interpersonal skills

Skills:

  • Process-oriented with good attention to detail
  • Effective written and verbal communication to explain complex concepts
  • Flexibility and adaptability to handle a dynamic workload

Benefits:

  • Opportunity to work with a dynamic team
  • Professional growth and development opportunities

Work Environment:

The ProductLife Group offers a collaborative and dynamic work environment, with opportunities for professional growth and development.

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