Data Information Specialist

2 days ago

Nagpur, Maharashtra, India beBeePharmacovigilance Full time ₹ 8,00,000 - ₹ 12,00,000

Job Overview:

  • We are seeking highly skilled professionals to join our team in data management. As a Data Information Specialist, you will be responsible for processing and verifying safety information received for clients.
  • You will also be required to manage email boxes, registration, triage, assignment and coordination for the processing of vigilance cases, follow-up requests with reporters, and responding to queries from clients and reporters.
  • An additional responsibility will be to carry out periodic reconciliations aimed at confirming the proper handling of all vigilance reports for clients.
  • Support and contribute to local pharmacovigilance activities as needed.
  • Participate in audits/inspections and resulting action plan.

Key Responsibilities:

  • Bachelor's or Master's degrees in Medicine, Pharmacy, nursing, or science related field, 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 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.

Requirements:

  • Excellent organizational and interpersonal skills.
  • Ability to work well within a team.
  • Excellent time management skills.
  • Accountability and autonomy with assigned tasks.
  • Process orientated with good attention to detail.
  • Effective communications skills both written and verbal to be able to explain complex concepts and address queries from the team.
  • Flexibility and adaptability to handle a dynamic workload.
  • Works well under pressure and working to timelines.
  • Safety database experience.

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