Data Integrity Specialist

2 weeks ago

Pushkar, Rajasthan, India beBeepharmacovigilance Full time ₹ 10,00,000 - ₹ 15,00,000
Pharmacovigilance Specialist

We are seeking a skilled Pharmacovigilance Specialist to join our team. The ideal candidate will have experience in pharmacovigilance, data entry and quality control.

  • Key Responsibilities:
  • Perform local safety case receipt, processing and data entry, quality control tracking and ICSR follow up of all safety information received for clients.
  • Manage generic or client-specific email boxes as necessary.
  • Register, triage, assign and coordinate vigilance cases for processing.
  • Follow up on requests from local reporters.
  • Respond to queries from clients and reporters.
  • Conduct periodic reconciliations to confirm proper handling of vigilance reports for clients.
  • Support local pharmacovigilance activities performed by the Local Safety/PV department when needed.
  • Participate in audits/inspections and resulting action plans.

Requirements:

  • Bachelor's or Master's degrees in Medicine, Pharmacy, nursing, or a science-related field or equivalent experience.
  • Minimum 2+ years' experience in pharmacovigilance working for service providers performing data entry and QC of cases.
  • Previous experience meeting deadlines.
  • Strong client communication skills.
  • Knowledge of US and EU PV regulations.
  • Pharmaceutical background with a strong understanding of GVP, GCP, FDA, and regulatory requirements related to drug safety.
  • Deep knowledge of pharmacovigilance principles, adverse event reporting, and 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 written and verbal communication to explain complex concepts and address team queries.
  • Flexibility and adaptability to handle dynamic workloads.
  • Ability to work under pressure while meeting timelines.
  • Safety database experience.

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