Job Description

- Performing activities in the scope of ICSR management unit within agreed extent and timeframe (including, but not limited to):
- Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines
- Performing ICSR follow up
- SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review)
- Reconciliation (clinical, partners)
- Intake, triage, assessment, data entry, follow-up and processing of medical device safety / incident reports.
- Performing quality review/QC of medical device cases, ensuring completeness, accuracy, consistency, coding and adherence to SOPs.
- Personal data protection
- Product Quality Complaint handling and interaction with Quality Assurance
- MedDRA and WHO coding
- Database Outputs and Reports (including data for monthly reporting to clients)
- Workflow & resource management
- Mentoring and training of recent and more junior employees within the department

📌 PV Officer (Medical Device & Product experience required) (Pune)
🏢 PrimeVigilance
📍 Pune