Piramal Group has interests in a portfolio of businesses including financial services (Piramal Enterprises Limited), pharmaceuticals (Piramal Pharma Limited), and real estate (Piramal Realty). With operations in 30 countries and brand presence in over 100 markets, the Group’s turnover is ~1.9 billion usd in FY 2022. Driven by its core values, the Group pursues inclusive growth, while adhering to ethical and value-driven practices.
Post : Executive Pharmacovigilance
Job Overview
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.
Job Description
• 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.
Candidate Profile
• B.Pharm / M.Pharm
• 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
• 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
Additional Information
Experience : 2-3 years
Qualification : B. Pharm / M.Pharm
Location : Kurla, Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Pharmacovigilance
End Date : 30th April 2024
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