What is Pharmacovigilance (PV)

According to the American Society of Pharmacovigilance, every year 1 million emergency department visits, 2.2 million hospital admissions, and 3.5 million physician office visits are caused by adverse drug effects. To prevent these tragedies, there is a special department in clinical research called pharmacovigilance. Pharmacovigilance, or drug safety, is the study of a drug’s adverse effects. PV professionals determine a drug’s safety and effectiveness before it is released into the market. 

PV is a vast and complex discipline that requires diverse skill sets. Some roles may require administrative expertise, while others require firm understanding of statistics. Regardless, the PV department’s teams and divisions all collaborate towards one goal: to improve drug safety. Some common PV positions include: 

Although there are many different positions within PV, many share common responsibilities such as:

  • Medical evaluation, 

  • Assessment of expectedness and drug-ADR associations, 

  • Casualty assessment, 

  • Case narratives and processing, 

  • Use of medical dictionaries, 

  • Data mining and signal detection, 

  • Medication error related activities 

  • Specialized services (writing, compliance, global PV, ect)

To work in PV, you need at least a bachelor’s degree in the health sciences as well as relevant experience. Many professionals from nursing, pharmacy, and medicine find successful careers in PV. However, it is a competitive field. In PV, technical qualifications and a well rounded understanding of the human body are everything. At CCRPS, we offer a pharmacovigilance certification course that will help you better understand the industry and improve your qualifications.

Explore Career Advancements in Pharmacovigilance

Pharmacovigilance Certification
This certification will equip you with the necessary skills to effectively manage and report adverse drug reactions and ensure compliance with regulatory laws.

  1. Clinical Research Coordinator Certification
    Learn the fundamentals of clinical research coordination, enhancing your ability to manage clinical trials and patient care effectively.

  2. CRA Certification
    As a Clinical Research Associate, gain expertise in monitoring clinical trials and ensuring adherence to established guidelines and regulations.

  3. ICH-GCP Certification
    This certification provides thorough training in the International Conference on Harmonisation - Good Clinical Practice guidelines, crucial for anyone involved in clinical trials.

  4. Clinical Trials Assistant Training
    Prepare for a role as a Clinical Trials Assistant, where you will support the administration and operational aspects of clinical trials.

  5. Advanced Clinical Research Project Manager Certification
    Develop advanced skills in managing complex research projects, overseeing trial progress, and ensuring projects meet their objectives.

  6. Advanced Principal Investigator Physician Certification
    This course is designed for physicians who wish to lead clinical trials, focusing on the intricacies of trial management and regulatory compliance.

  7. Medical Monitor Certification
    Gain specialized skills in monitoring and overseeing the medical aspects of clinical trials, ensuring patient safety and the integrity of clinical data.

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What is the Role of Pharmacovigilance in Clinical Research