Key Responsibilities:
- Collect and review individual case safety reports (ICSRs) from various sources.
- Perform data entry and quality checks in safety databases.
- Conduct medical coding using MedDRA and WHO-DD.
- Assist in preparation and submission of regulatory safety reports (e.g., PSURs, DSURs, expedited reports).
- Monitor signal detection and risk assessment activities.
- Ensure compliance with SOPs, regulatory guidelines (e.g., ICH, EMA, FDA), and company policies.
- Support audits and inspections related to pharmacovigilance.
Job Type: Full-time
Pay: ₹20,000.00 - ₹54,000.00 per month
Work Location: In person
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