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Executive Pharmacovigilance

2 weeks ago

Mumbai Maharashtra, India Piramal Pharma Solutions 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 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

**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.