Data Safety Specialist

2 weeks ago

Agra, Uttar Pradesh, India beBeeRegulatory Full time ₹ 50,00,000 - ₹ 75,00,000
Pharmacovigilance Officer

The role of a Pharmacovigilance Officer is crucial in ensuring the safety and quality of pharmaceutical products. As a member of our team, you will be responsible for processing local safety cases, performing quality control tracking, and following up on adverse event reports.

Responsibilities:

  • To receive, process, and enter data into our safety database, adhering to agreed timelines and requirements
  • Management of email boxes as appropriate
  • Registration, triage, assignment, and coordination of vigilance case processing
  • Follow-up requests with local reporters
  • Responding to queries from clients and reporters
  • Periodic reconciliation to confirm proper handling of all vigilance reports
  • Supporting local pharmacovigilance activities as needed

Requirements:

  • Bachelor's or Master's degrees in Medicine, Pharmacy, Nursing, or Science related field, or equivalent experience
  • 2+ years' experience in pharmacovigilance, including data entry and QC of cases
  • Proven track record of working to deadlines
  • Excellent client communication skills
  • Knowledge of US and EU PV regulations
  • Strong understanding of GVP, GCP, FDA, and regulatory requirements

Skills:

  • Excellent organizational and interpersonal skills
  • Ability to work well within a team
  • Excellent time management skills
  • Accountability and autonomy with assigned tasks
  • Process-orientated with good attention to detail
  • Effective written and verbal communication
  • Flexibility and adaptability to handle a dynamic workload

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