Medical Vigilance Solutions
Pharmacovigilance

A Comprehensive Suite of Safety Surveillance and Regulatory Compliance Services

One of your top priorities is ensuring safety for every product you manufacture and every clinical trial you run. You can count on the Medical Vigilance Solutions pharmacovigilance team to help you achieve that goal with reliable, accurate safety surveillance from phase 1 clinical trials to the postmarket arena.

Our highly trained pharmacists, nurses and allied health professionals provide comprehensive Pharmacovigilance services for drugs and devices, biologics and consumer product goods in both the clinical trial and postmarket arenas. These healthcare professionals expertly handle all aspects of case processing activities, from adverse event intake and assessment/triage to data entry, narrative writing and coding, through follow-up and medical and quality reviews.

Pharmacovigilance team members can utilize a variety of systems, including our own in-house validated safety database or client platforms, such as ARGUS, iMedidata Rave and REDCap.

Our seasoned professionals have industry experience and deep therapeutic expertise in many medical subspecialty areas, which include but are not limited to:

  • Bone health
  • Cardiovascular health
  • Dermatology
  • Gastrointestinal medicine
  • Immunology
  • Infectious diseases
  • Nephrology
  • Neurology
  • Oncology
  • Organ transplantation
  • Rheumatology
  • Women’s health

Our Comprehensive Pharmacovigilance Suite of Services

  • On-time, accurate reporting of periodic and ICSR regulatory submissions and preparation of aggregate reports (PADER, PSUR, etc.)
  • SUSAR submission to FDA for clinical trials 
  • Data analysis and signal detection 
  • Regulatory agency pharmacovigilance audit support (PV auditing) 
  • Surveillance and analysis of global medical literature 
  • Specialized clinical trial services, including MedDRA and WHODrug coding 
  • Pharmacovigilance risk management services for high-risk pharmaceutical drugs 

If your partnership with MVS includes our Medical Information Contact Center, you’ll benefit from creative, efficient collaborations that add value to your company and customers. Whatever surveillance and compliance challenges your company faces, MVS has customized solutions to propel your business forward.