Job Title
Executive Pharmacovigilance
Department
Pharmacovigilance
Qualification
B. Pharma/ M. Pharma
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.
Reporting Structure
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 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 ICSPR.
* 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.
Business
Piramal Critical Care
Location
Kurla, Mumbai
Travel
Low
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