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Piramal Pharma

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4.0

based on 851 Reviews

255 Piramal Pharma Jobs

Executive Pharmacovigilance

Piramal Pharma Limited

4.0

based on 851 Reviews

2-3 years

Mumbai

1 vacancy

Executive Pharmacovigilance

Piramal Pharma

posted 7hr ago

Job Role Insights

Flexible timing

Key skills for the job

Pharmacovigilance Supply Chain Management Microsoft Power BI Database Management English Literature Compliance

+ 4 more

Job Description

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 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

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 .