
PV Department Head
2 weeks ago
Pharmacovigilance Manager Job Overview
">- Project Management: Coordinate and allocate resources for PV projects efficiently to ensure a smooth workflow.
- Staff Development: Train, mentor, and guide PV department staff as needed.
- Financial Administration: Generate and distribute monthly invoices to all PV clients regularly.
- Regulatory Compliance: Maintain up-to-date departmental CVs, job descriptions, and training records in accordance with regulatory requirements.
- Compliance Oversight: Ensure that PV staff comply with all training requirements at all times.
- Audit Representation: Represent the PV department during client audits and regulatory authority inspections.
- Document Review: Prepare 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 necessary.
- Case Documentation: Complete and document cases accurately.
Requirements
">- Qualification: Bachelor's degree in Pharmacy (B.Pharm), Dentistry (BDS), Pharm D, or Master's degree in Pharmacy (M.Pharm).
- Experience: Minimum of 5-8 years in pharmacovigilance experience.
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