Senior Safety Professional

1 day ago

Belgaum, Karnataka, India beBeeData Full time ₹ 8,00,000 - ₹ 12,00,000
Pharmacovigilance Officer

Our organization is seeking a detail-oriented and organized Pharmacovigilance Officer to contribute to our team. This role will be responsible for ensuring timely and accurate processing of safety information for our clients.

Key Responsibilities:
  • Perform local safety case receipt, processing, and data entry, as well as quality control tracking and ICSR follow-up of all safety information received from clients.
  • Manage email boxes as appropriate.
  • Register, triage, assign, and coordinate the processing of vigilance cases.
  • Follow up on requests with local reporters.
  • Respond to queries from clients and reporters.
  • Carry out periodic reconciliations to confirm proper handling of all vigilance reports for clients.
  • Support and contribute to local pharmacovigilance activities performed by the department as needed.
  • Participate in audits/inspections and resulting action plans.
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 under deadlines.
  • Client communications skills.
  • Knowledge of US and EU PV regulations.
  • 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.
  • Able 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 dynamic workload.
  • Ability to work well under pressure and meet timelines.
  • Safety database experience.

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