Pharmacovigilance

With years of experience delivering regulatory support for our clients’ pharmacovigilance needs, our highly qualified team of safety professionals adheres to good pharmacovigilance practices with timely regulatory screening and reporting of adverse events and product complaints.

  • Complete initial screening for adverse events and product complaints
  • Prepare case narratives of Individual Case Safety Reports (ICSRs) from clinical trial and postmarketing sources
  • Provide detailed and systematic follow-up for all cases
  • Enter data into client’s safety database including:

    Evaluation of serious criteria

    Coding using MedDRA, WHO Drug, Company Drug Dictionary

    Expedited submission of ICSRs

  • Conduct medical review of cases
  • Conduct quality control activities
  • Conduct quality assurance activities
  • Pharmacovigilance consulting

  • Patient safety activities supporting pharmacovigilance regulations: case processing, periodic reports, signal detection, IND reports

  • Detect, track, investigate, and evaluate signals and risk-benefit of product

  • Prepare regulatory safety reports (eg, PADERs, PSURs, PBRERs)

  • Conduct systematic review of medical literature

  • Provide metric reports on compliance, quality, and other key performance indicators

  • Write/revise standard operating procedures based on good pharmacovigilance practices

  • Provide support for Risk Management Plans (RMPS) and Risk Evaluation Mitigation Strategies (REMS)

  • Include comprehensive MedDRA upgrades, in both English and Japanese, utilizing BKP Technologies’ BKP Codex Up-Versioning tool

  • Conduct audit inspection/readiness

Pharmacovigilance

Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem.1

Patient safety is always a priority for pharmaceutical companies. Making medicines to improve lives requires monitoring all aspects of safety and assessing the data associated with the patient experience for the life of the product. The tasks associated with the collection, input, and assessment of the adverse event information are performed by skilled health care professionals. Across the industry, these professionals are technically proficient. They recognize the importance of staying current, given the dynamic regulatory environment around the world.

The collection and processing of adverse event information requires many steps by individuals with special training in pharmacovigilance. The manner in which these steps are executed are dictated by regulations. Each country or geographical area are governed by regulatory authorities. Each of these regulatory authorities, where a product is marketed, determine how and when qualifying adverse event information gets reported. Pharmaceutical companies often rely on external vendors to perform daily or periodic regulatory reporting tasks on their behalf.

Med Communications has a global pharmacovigilance team ready to serve your company’s needs. Physicians, pharmacists, nurses, and other health care professionals are fully trained in all aspects of pharmacovigilance and provide outstanding support.

The Pharmacovigilance department within Med Communications is able to assist your company in all facets of pharmacovigilance to ensure you meet your regulatory obligations. We can guide your company on the type of pharmacovigilance services needed, from specific pieces of the case management process to our “white glove” full-service activities. We pride ourselves on maintaining an inspection-ready approach for all tasks performed and support our clients during inspection, taking responsibility for our outsourced work. We welcome the opportunity to discuss your company’s pharmacovigilance needs. Pharmacovigilance will continue to evolve and our Med Communications team is committed to keeping current with industry and regulatory trends and guidelines to keep patient safety a priority!

References:

1 World Health Organization. The importance of pharmacovigilance: safety Monitoring of medicinal products. [Internet]. 2002. [cited 14 Oct 2020]. Available from: http://whqlibdoc.who.int/hq/2002/a75646.pdf?ua=1&ua=1

Risk Management

Risk management activities within pharmacovigilance have evolved in the last several years. The development of new products outside of the traditional small and large molecules require broader views of how to obtain adverse event information and use current technologies to assess this data. The industry must keep an eye to the future and be prepared to anticipate how best to capture and evaluate this data.

According to the Drug Information Association (DIA), “Today’s safety and pharmacovigilance professionals assess and manage risk of a broad and changing scope of therapeutic products. Their ability to apply best practices in current daily operations while anticipating coming changes associated with new therapies and technologies is key to putting safe products on the market and optimizing benefits to patients.”1

Health care professionals working in pharmacovigilance understand this changing landscape and are trained to navigate through the data points to guide companies in determining safety profiles for their product. This information helps populate the reference safety information / product label and helps guide the architecture of future trials to further learn about safety and the patient experience.

The pharmacovigilance team at Med Communications are highly skilled in the assessment and evaluation of safety information. The benefit-risk profile of a product is reviewed per regulatory guidelines. Our global pharmacovigilance team works cohesively with our clients to provide robust assessment and documentation. We remain inspection-ready as we perform our work and support our clients during inspection, taking responsibility for our outsourced work.

We welcome the opportunity to discuss your company’s pharmacovigilance needs. Risk Management will continue to evolve and our Med Communications team is committed to keeping current with industry and regulatory trends and guidelines to keep patient safety a priority!

Reference:

1 Drug Information Association. Pharmacovigilance and risk management in 2020: A global perspective. 2020 [Internet]. 2015 [cited 14 May 2020]. Available from: http://engage.diaglobal.org/2020-Global-PV-eBook.html

Contact Us Today

A Total Medical Affairs Solution

With over 20 years of medical affairs experience in the pharmaceutical, biotech, and medical device industries, Med Communications has emerged as a leading medical affairs service provider.
Contact Us Today

Our Partners