Data Analysts Officer

23 hours ago

Mysore, Karnataka, India beBeePharmacovigilance Full time ₹ 60,00,000 - ₹ 1,20,00,000
Senior Pharmacovigilance Specialist

We are seeking a highly skilled Senior Pharmacovigilance Specialist to join our team. As a key member of our pharmacovigilance department, you will be responsible for ensuring the quality and integrity of safety data received from clients.

Key Responsibilities:
  • Manage local safety case receipt, processing, and data entry, as well as quality control (QC) tracking and ICSR follow-up of all safety information received for clients.
  • Register, triage, assign, and coordinate the processing of vigilance cases.
  • Follow up with local reporters and respond to queries from clients and reporters.
  • Perform periodic reconciliations to confirm the proper handling of all vigilance reports for clients.
Requirements:
  • Bachelor's or Master's degree in Medicine, Pharmacy, nursing, or a science-related field, or equivalent experience.
  • 2+ years' experience in pharmacovigilance working for service providers performing data entry and QC of cases.
  • Previous experience working to deadlines.
  • Client communications.
  • 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.
Preferred Skills:
  • Excellent organizational and interpersonal skills.
  • Ability to work well within a team.
  • Excellent time management skills.
  • Accountability and autonomy with assigned tasks.
  • Process-oriented with good attention to detail.
  • Effective communications skills both written and verbal.
  • Flexibility and adaptability to handle a dynamic workload.

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