Job description

Business: Critical Care

Department: Pharmacovigilance

Location: Kurla, Mumbai

Travel: No

Reporting Structure

Reports to Manager

Essential Qualification

Bachelors/ Masters degree in Pharmacy

Experience

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

Key Roles/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.

Senior Executive