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Pharmacovigilance Consulting

Drug safety, also known as pharmacovigilance (PV), is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical or device products. Ultimately, drug safety is concerned with identifying the hazards associated with pharmaceutical products and with minimizing the risk of any harm that may come to patients.

Our highly skilled consultants typically fill the roles of Safety Physicians or Medical Leads, Safety Specialists, and Safety Scientists in the areas of:

  • Case processing
  • Oversight of CRO of pharmacovigilance activities
  • REMS and risk/benefit analysis
  • SOP/Work instructions development for pharmacovigilance activities
  • Clinical trial and post market case processing
  • CRO oversight of safety related activities
  • Global aggregate safety report preparation
  • Development of Risk Management Plans/REMS and Risk/Benefit analysis
  • SOP/Work instructions development for clinical trial safety/pharmacovigilance activities
  • Strategic consulting

Contact Us
For help managing your next clinical trial, contact BioBridges today.

    At BioBridges, we have highly skilled consultants with extensive experience in the biotech, pharmaceutical, and medical device industry. With a wide range of expertise, these life science consultants are incredibly well suited to step in and immediately provide valuable contributions to your development programs. Whether you are an emerging start-up or an established company, looking for individuals or functional teams, BioBridges' consultants provide guidance and support to accomplish the objectives across all areas of clinical development. You can accomplish the work with experienced professionals whose passion is to focus on programs that inspire them, move important work forward, and make an impact. Engaging BioBridges gives you the ability to accomplish the work at hand.

    Over the past few years, I have been contacted by an number of agencies regarding projects. Most turn out to be “black holes” where I submit a resume and never hear anything back. BioBridges has reached out to me with a number of opportunities. I am now working with a gene editing company who plans to file their first IND later this year. I appreciate all of the attention and guidance I receive from BioBridges, and highly recommend them.

    William Heydon

    | BioBridges Professional