Senior Executive

Business: Critical Care

Department: Pharmacovigilance

Location: Kurla, Mumbai

Travel: No

Reporting Structure

Reports to Manager

Essential Qualification

Bachelors/ Masters degree in Pharmacy

Experience

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• Overall 2-3 years of experience in Pharmacovigilance with at least 1 year of relevant work experience in ICSR processing,
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• Literature screening and authoring of aggregate safety reports like PADERs, PBRERs etc.
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Key Roles/Responsibilities

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• 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.
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• 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.
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• Perform and monitor literature for company molecules.
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• Maintain and update safety logs and safety files.
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• Prepare and share compliance data with QPPV.
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• Provide data for compliance representation/monthly information system.
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• Assist in handling of product complaints and reconciliation.
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• Assist in responding to queries and requests related to safety of products and Pharmacovigilance system from regulatory authorities.
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• Prepare for internal or external audits and inspections.
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• Preparation/Drafting of aggregate reports (PADER and PSURs).
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• Coordination with different stakeholders for data request etc. for fulfilment of Pharmacovigilance responsibilities.