Executive - Pharmacovigilance

3 days ago

Mumbai Maharashtra, India Piramal Pharma Solutions Full time

Business: Critical Care

Department: Pharmacovigilance

Location: Kurla, Mumbai

Travel: No

**Reporting Structure**

Reports to Manager

**Key Roles/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 responding to queries and requests related to safety of products and Pharmacovigilance system from regulatory authorities.
- Prepare for internal or external audits and inspections.

Coordination with different stakeholders for data request etc. for fulfilment of Pharmacovigilance responsibilities.

**Essential Qualification**

Bachelors/ Masters degree in Pharmacy

**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

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