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2 weeks ago
The primary objective of this role is to collect, process and analyze safety information from various sources.
Main Responsibilities:
- Managing the receipt, processing and entry of local safety case data in accordance with agreed timelines.
- Performing quality control (QC) tracking and follow up of all safety information received for clients.
- Registering, triaging, assigning and coordinating the processing of vigilance cases.
- Responding to queries from clients and reporters, carrying out periodic reconciliations to confirm proper handling of vigilance reports.
- Participating in audits and inspections to ensure compliance with regulatory requirements.
Requirements:
- Bachelor's or Master's degree in Medicine, Pharmacy, Nursing, or a related field.
- Minimum 2 years' experience in pharmacovigilance, including data entry and QC of cases.
- Excellent organizational and interpersonal skills, ability to work well within a team.
- Familiarity with US and EU PV regulations, pharmaceutical background and GVP principles.
Key Skills:
- Pharmacovigilance principles, adverse event reporting, causality assessment.
- Excellent communication and problem-solving skills.
- Able to work in a dynamic environment with multiple priorities and deadlines.
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