Executive Pharmacovigilance

Business: Piramal Critical Care
Department: Pharmacovigilance
Location: Kurla, Mumbai
Travel: Low

The Executive Pharmacovigilance will be responsible 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.

This role reports to the Manager - Pharmacovigilance

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.
• Good communication and interpersonal skills, both written and verbal
• Ability to manage multiple concurrent tasks
• Proven ability to meet strict deadlines
• Ability to work independently and in a team environment
• Competent in use of desktop applications: Microsoft word, excel and PowerPoint

Key Role and 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 .