Data Case Manager

3 days ago

Thoothukudi, Tamil Nadu, India beBeePharmacovigilance Full time ₹ 9,00,000 - ₹ 12,00,000
Pharmacovigilance Officer

We are seeking a skilled Pharmacovigilance Officer to join our team. As a key member of the Local Safety department, you will be responsible for processing and managing pharmacovigilance cases.

Responsibilities:

  • To perform local safety case receipt, processing and data entry, quality control (QC) tracking and ICSR follow up of all safety information received from clients.
  • Management of generic or client-specific email boxes as required.
  • Registration, triage, assignment and coordination for the processing of vigilance cases.
  • Follow-up requests with local reporters.
  • Responding to queries from clients and reporters.
  • To carry out periodic reconciliations aimed at confirming the proper handling of all vigilance reports for PLG Clients.
  • Support/Contribute to local pharmacovigilance activities performed by the Local Safety/PV department as needed.
  • To participate in audits/inspections and resulting action plan.

Requirements:

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

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.
  • Works well under pressure and working to timelines.
  • Safety database experience.

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