Lead Pharmacovigilance Specialist
5 days ago
The ideal candidate will have a strong understanding of pharmacovigilance principles and be able to demonstrate excellent case management skills.
Key Responsibilities:
- End-to-end case management, including case receipt, facilitation of case follow-up, case download from regulatory authority websites, database entry, peer review and submission to applicable regulatory authorities within stipulated timelines.
- Mailbox management and tracking of incoming individual case safety reports (ICSRs). Reconciliation of ICSRs. Enter and/or submit cases to applicable regulatory authority safety databases.
- Perform and monitor literature for company molecules.
- Maintain and update safety logs and safety files.
- Prepare and share compliance data with QPPV.
- Provide data for compliance representation/monthly information system.
- Assist in handling of product complaints and reconciliation.
- Assist in responding to queries and requests related to safety of products and pharmacovigilance system from regulatory authorities.
- Prepare for internal or external audits and inspections.
- Preparation/drafting of aggregate reports (PADER and PSURs).
- Coordination with different stakeholders for data request etc. for fulfilment of pharmacovigilance responsibilities.
Bachelor's/Master's degree in Pharmacy is required. Minimum 2-3 years of experience in pharmacovigilance with at least one year of relevant work experience in ICSR processing, literature screening and authoring of aggregate safety reports.
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