Data Officer Role

2 weeks ago

Malappuram, Kerala, India beBeeData Full time ₹ 8,22,510 - ₹ 11,44,750

We are seeking highly motivated professionals to join our team as Data Officers. The successful candidate will contribute to the activities performed in the Hub, working closely with a dynamic team.

Job 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 appropriate.
  • Register, triage, assign and coordinate for the processing of vigilance cases.
  • Follow up requests with local reporters.
  • Respond to queries from clients and reporters.
  • Carry out periodic reconciliations to confirm proper handling of vigilance reports for clients.
  • Support local pharmacovigilance (PV) activities performed by the Local Safety/PV department as needed.
  • Participate in audits/inspections and resulting action plan.
Key Skills and Qualifications:
  • Bachelor's or Master's degree in Medicine, Pharmacy, nursing, or science related field, or equivalent experience.
  • At least 2 years' experience in pharmacovigilance working for service providers performing data entry and QC of cases.
  • Previous experience working to deadlines.
  • Strong knowledge of US and EU PV regulations.
  • Pharmaceutical background - strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety.
  • Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment.

The ideal candidate should have excellent organizational and interpersonal skills, ability to work well within a team, and effective communication skills both written and verbal.

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