Pharmacovigilance Data Specialist

3 days ago

Dombivli, Maharashtra, India beBeeData Full time ₹ 90,00,000 - ₹ 1,20,00,000
Job Title: Data Officer

As a Data Officer, you will play a crucial role in the successful operation of our Pharmacovigilance (PV) department. You will be responsible for managing and processing safety information received from our clients, ensuring timely and accurate entry of data into our systems.

Key Responsibilities:

  • Local Safety Case Management: Perform local safety case receipt, processing, and data entry, quality control (QC) tracking, and ICSR follow-up of all safety information received for PLG clients.
  • Email Management: Manage generic or client-specific email boxes as appropriate.
  • Vigilance Case Coordination: Register, triage, assign, and coordinate the processing of vigilance cases.
  • Client Communication: Follow up requests with local reporters and respond to queries from clients and reporters.
  • Reconciliation and Reporting: Carry out periodic reconciliations to confirm proper handling of all vigilance reports for PLG clients and support pharmacovigilance activities performed by the Local safety/PV department as needed.

Requirements:

  • Education: Bachelor's or Master's degrees in Medicine, Pharmacy, nursing, or science-related field, or equivalent experience.
  • Experience: 2+ years' experience in pharmacovigilance working for service providers performing data entry and QC of cases.
  • Communication Skills: Previous experience working to deadlines and excellent client communications skills.
  • Knowledge and Skills: Knowledge of US and EU PV regulations, pharmaceutical background understanding GVP, GCP, FDA, and regulatory requirements related to drug safety, and deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment.

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