Work alongside experienced pharmacovigilance specialists to support clinical trial and post-marketing safety surveillance throughout the clinical trial and post-marketing/commercialization phases of your product lifecycle.

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Pharmacovigilance Staff Augmentation

Our safety and pharmacovigilance experts utilize a deep knowledge of regulatory legislation and a focus on quality safety to provide effective solutions for compliant global pre- and post-approval pharmacovigilance.

Our pharmacovigilance specialists can manage a variety of safety, quality, and compliance activities including, but not limited to:

  • Clinical trial safety

    • Phase I-IV, from data entry to case closure, full processing, including expedited/periodic reporting
  • Post-marketing safety

    • AE case processing, reporting, signal detection, product complaints, EU QPPV, and litigation case processing
  • Regulatory submissions for safety

    • Expertise in safety regulatory legislation and submissions
  • Safety physicians

    • Expertise throughout the lifecycle of safety and pharmacovigilance

Our resources can be utilized to meet the wide range of drug safety and pharmacovigilance requirements throughout the life sciences, as well as to support staffing assignments, lead and manage related activities, bridge staffing gaps, and provide long-term or interim leadership.

Please contact us to learn more about fulfilling specific pharmacovigilance staffing needs. We help clients secure a wide variety of drug safety specialists with the perfect combination of qualifications, experience, and motivation for succeeding in challenging and demanding projects.

Why work with The FDA Group?

  • Get quick, easy access to industry resources.

  • Fulfill short or long-term staffing needs at a competitive rate.

  • Get a flexible alternative to traditional full-time hiring.

  • Receive dedicated project management and a Total Quality Guarantee.

Brochure Learn more about our staff augmentation services.

Read our brochure to learn more about staff augmentation and our full range of life science resourcing capabilities.

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Contact us today to learn more about our pharmacovigilance staff augmentation services.