Executive Pharmacovigilance

2 weeks ago

Mumbai, Maharashtra, India Piramal Group Full time

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

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
 

Key Stakeholders: Internal Quality, Sales, Supply Chain, and Regulatory Affairs teams Key Stakeholders: External  Vendors and auditors
Reporting Structure: This role reports to the Manager - Pharmacovigilance
Experience: 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 Competencies:
•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.

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