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Pharmacovigilance

Agile, scalable pharmacovigilance services you can trust

Supporting Patient Safety and Product Longevity

Patient safety is your priority – and ours. We can help you look after patients and ensure you meet regulatory requirements, through a customized, integrated pharmacovigilance (PV) solution.

Designed to precisely meet your needs — with up/down scalability as requirements change. Your solution will be configured from our comprehensive range of pharmacovigilance services:

  • Adverse event reporting
  • Global case processing
  • Regulatory intelligence
  • Risk management
  • Literature searches
  • Trending and signal detection
  • Global aggregate reporting
      • PSURs. PBRERs, and PADERs
  • Medical reviews and writing
  • Pharmacovigilance consulting
  • Global Regulatory submissions
  • Clinical trial management
      • ICSR management
      • Medical review of ICSRs
      • Analysis of Similar Event writing
      • DSURs
      • Data trending and analysis
      • SUSAR unblinding
      • Database reporting
      • SAE reconciliation
      • Regulatory submissions
      • Preparation of Investigator / Ethics Committee letters and packets

The dedication and skills needed to successfully navigate pharmacovigilance

Ashfield Pharmacovigilance is a trusted advisor and the vendor of choice for quality and commitment to clients. Our established reputation and robust processes allow you to focus on your core business, while we operate as a true extension of it.

Your Ashfield PV solution can act as a full-service safety department, with flexibility and scalability to address evolving needs. To address more specialized needs, you may choose an Ashfield solution to augment your case management, signal detection, or medical writing. In every case, our solutions are tailored to fit each partner’s needs.

Complete capabilities and expertise for turn-key solutions

Ashfield has been focused on drug safety for almost 20 years. All Ashfield pharmacovigilance services are delivered by a highly qualified team, in strict accordance with the Ashfield Quality Management Framework and rigorous compliance processes. Our infrastructure and technology, ensure secure and consistent data capture, management, and reporting on all agreed measures of performance, including quality and productivity.

Your Ashfield PV solution will leverage the following capabilities and experience:

  • Experienced staff:
      • 66% HCPs
      • 95% science degrees
  • 99% of case managers are life science or healthcare professionals
  • 99% of cases submitted on time
  • 200,000+ cases processed annually
  • 1,000+ aggregate reports completed annually
  • 900+ generic and Rx products supported
  • No 483s or critical findings

Contact us

Speak to us about how we can provide tailor made solutions for you.

Ashfield offers a wide range of world-class, market leading services that include medical sales teams, inside sales, contact centers, clinical educators, patient support programs, medical communications, medical information, meetings and events, market research, pharmacovigilance and training.

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