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Piramal Finance logo

Executive - Pharmacovigilance

2 - 4 years

4 - 6 Lacs

Mumbai

Posted:3 weeks ago| Platform: Naukri logo

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Skills Required

Pharmacovigilance Regulatory Submission Mailbox Management Case Management Individual Case Safety Report Database Entry ICSR Reconciliation Case Receipt & Follow-up ICSR Processing Literature Monitoring

Work Mode

Work from Office

Job Type

Full Time

Job Description

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 Competent in use of desktop applications: Microsoft word, excel and PowerPoint

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Piramal Finance
Piramal Finance
www.piramal.com/finance

Financial Services

Mumbai

250+ Employees

144 Jobs

    Key People

  • Ajay Piramal

    Chairman

  • Shreyas Tiwari

    CEO

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