Senior Data Integrity Specialist

2 days ago

Mangalore, Karnataka, India beBeeDataOfficer Full time ₹ 8,00,000 - ₹ 12,00,000
Data Officer Job Description

As a Data Officer, you will play a crucial role in ensuring the quality and integrity of safety information received from clients. You will be responsible for performing local safety case receipt, processing and data entry, quality control (QC) tracking and ICSR follow up.

This is an excellent opportunity to join our team and make a meaningful contribution to the field of pharmacovigilance. If you are a detail-oriented individual with excellent organizational skills and a strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety, we encourage you to apply.

Responsibilities
  • Perform local safety case receipt, processing and data entry, quality control (QC) tracking and ICSR follow up of all safety information received from clients.
  • Manage generic or client-specific email boxes as appropriate.
  • Register, triage, assign and coordinate 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 all vigilance reports from clients.
Requirements
  • Bachelor's or Master's degrees in Medicine, Pharmacy, Nursing, or science-related fields, 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.
  • Client communications.
  • Knowledge of US and EU PV regulations.
  • Pharmaceutical background - strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety.
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 communication skills both written and verbal to explain complex concepts and address queries from the team.
  • Flexibility and adaptability to handle a dynamic workload.
  • Safety database experience.

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