Piramal Critical care is hiring B. Pharma/ M. Pharma as a Executive Pharmacovigilance – Apply Now

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Attention B.Pharm and M.Pharm graduates! Piramal Critical Care is actively seeking talented individuals to join us as Executive Pharmacovigilance. If you’re passionate about ensuring the safety and efficacy of pharmaceutical products, this could be the perfect opportunity for you. Join our team and play a crucial role in maintaining pharmacovigilance standards. Apply now to take the next step in your pharmaceutical career!

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:
1. 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.
2. Mailbox management and tracking of incoming Individual case safety reports (ICSRs). Reconciliation of ICSRs.
3. Enter and/ or submit cases to applicable regulatory authority safety databases.
4. Perform and monitor literature for company molecules.
5. Maintain and update safety logs and safety files.
6. Prepare and share compliance data with QPPV.
7. Provide data for compliance representation/monthly information system.
8. Assist in handling of product complaints and reconciliation.
9. Assist in responding to queries and requests related to safety of products and Pharmacovigilance system from regulatory authorities.
10. Prepare for internal or external audits and inspections.
11. Preparation/Drafting of aggregate reports (PADER and PSURs).
12. Coordination with different stakeholders for data request etc. for fulfilment of Pharmacovigilance responsibilities.

Business: Piramal Critical Care

Location: Kurla, Mumbai

Travel: Low

APPLY NOW

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