Pharmacovigilance Specialist
3 weeks ago
Company: Piramal Critical Care
Location: Kurla, Mumbai
Job Type: Full-time
About Us:
Piramal Critical Care is a leading manufacturer of critical care products. We are seeking an Executive Pharmacovigilance to join our team.
Job Summary:
We are looking for a highly motivated and detail-oriented Executive Pharmacovigilance to manage 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.
Key Responsibilities:
Manage 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.
Requirements:
Overall, - years of experience in Pharmacovigilance with at-least 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
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