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Open in new tab Strategic Pharmacovigilance Vendor Outsourcing
When it comes to Pharmacovigilance Vendor Outsourcing, successful due diligence is the first step toward a compliant partnership. As pharma companies scale, outsourcing becomes necessary, but it introduces significant regulatory risk if not managed correctly.
Key Steps in Due Diligence
Before signing a contract for Pharmacovigilance Vendor Outsourcing, you must evaluate:
Quality Management Systems: Does the vendor have a robust QMS?
Staff Qualifications: Are the medical reviewers properly trained?
Technical Infrastructure: Is their safety database validated?
Strong Pharmacovigilance Vendor Outsourcing relies on a clear Safety Data Exchange Agreement (SDEA) to ensure that the MAH (Marketing Authorization Holder) retains ultimate oversight.