Data Officer Specialist

2 weeks ago

Tiruchi, Tamil Nadu, India beBeeSpecialist Full time ₹ 9,00,000 - ₹ 12,00,000
Pharmacovigilance Specialist

We are seeking a skilled Pharmacovigilance Specialist to join our team in the Easter USA Time Zone. As a member of our safety and pharmacovigilance team, you will play a crucial role in ensuring the safe use of medications by managing and monitoring adverse events.

Key responsibilities include:

  • Managing local safety case receipt, processing and data entry, quality control (QC) tracking and ICSR follow up of all safety information received for clients.
  • Registering, triaging, assigning and coordinating vigilance cases for processing.
  • Following up with local reporters and responding to queries from clients and reporters.
  • Conducting periodic reconciliations to confirm proper handling of vigilance reports for clients.
  • Supporting local pharmacovigilance activities performed by the Local Safety/PV department as needed.

Requirements include:

  • Bachelor's or Master's degrees in Medicine, Pharmacy, nursing, or science-related fields, or equivalent experience.
  • 2+ years of experience in pharmacovigilance working for service providers, including data entry and QC of cases.
  • Previous experience meeting deadlines and managing client communications.
  • Knowledge of US and EU PV regulations and a strong pharmaceutical background.
  • Deep understanding of pharmacovigilance principles, adverse event reporting, causality assessment, and GVP/GCP/FDA requirements.

Skills required:

  • Excellent organizational and interpersonal skills.
  • Ability to work well within a team.
  • Effective time management and accountability for assigned tasks.
  • Attention to detail and adaptability in a dynamic environment.
  • Strong communication skills for explaining complex concepts and addressing team queries.

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