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PV Assistant Manager

5 - 8 years

8 - 13 Lacs

Remote India

Posted:22 hours ago| Platform: Foundit logo

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Skills Required

pharmacovigilance SDEAs Sops PharmaLex QA documents

Work Mode

On-site

Job Type

Full Time

Job Description

  • Project Management:

    Coordinate and allocate resources for PV projects, ensuring efficient workflow.

  • Staff Training:

    Train and mentor PV department staff as needed.

  • Invoicing:

    Ensure that monthly invoices for all PV clients are generated and distributed regularly.

  • Compliance Oversight:

    Maintain up-to-date departmental CVs, job descriptions, and training records in accordance with SOPs.

  • Training Compliance:

    Ensure that PV staff are compliant with training requirements at all times.

  • Audit Representation:

    Represent the PV department during client audits and regulatory authority inspections.

  • Document Review:

    Write and review QA documents, including SDEAs, Working Instructions, SOPs, and templates for PharmaLex PV projects.

  • Training Organization:

    Organize and conduct training on the aforementioned documents.

  • Case Processing:

    Handle case processing, including data entry and quality control (QC).

  • Follow-Up Requests:

    Prepare and send follow-up requests as needed.

  • Case Documentation:

    Complete and document cases accurately.

Your Profile:

  • Qualification:

    B.Pharm, BDS, Pharm D, or M.Pharm.

  • Experience:

    Minimum of 5-8 years in pharmacovigilance.

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