Drug Safety & Pharmacovigilance

Drug safety and pharmacovigilance are extremely important functions throughout the development, marketing and continued use of any medication. People in these roles are responsible for monitoring, controlling, processing and reporting the adverse event data obtained from various clinical trials and post-marketing safety. A career in drug safety and pharmacovigilance starts with a position as a drug safety associate, officer, scientist or coordinator. Responsibilities then progress to senior specialist or management roles, often with an in-depth knowledge of a specialty area. Post-marketing pharmacovigilance programs remain a vital part of any biopharmaceutical company’s overall pharmaceutical risk management strategy. Because Phase III clinical trials typically enroll no more than a few thousand patients, they cannot answer every question about a product’s risks and side effects, such as:

  • Are there rare events that will only manifest themselves when more people use the product? 
  • Are there specific risks for certain populations, such as younger or older people, or those with other conditions? 
  • Are the risks different if a drug is taken over a long period of time for a chronic condition?

Following are some main responsibilities of pharmacovigilance professionals:

  • Attend and accurately document the important telephone calls or faxes from various investigative sites

                     Report adverse events spontaneously and on time

  • Monitoring, collecting and processing the obtained data in a safe database according to the applicable standards, regulations and guidelines
  • Prioritize the event or case according to the applicable guidelines and project requirements
  • Ensuring quality by following various standards, guidelines, regulations and project requirements
  • Completing projects before or on time and within budget Ensure integrity, accuracy and completeness of data
  • Understand and communicate the budget and scope of the assigned project
  • Arranging for various clinical trial investigator and client meetings accordingly

                                             
Phase IIIb and Phase IV post-marketing pharmacovigilance programs typically monitor the use of a product in a larger population and over a longer period of time – gathering data on reported adverse events and other safety concerns to ensure that a product’s benefit/risk profile remains acceptable.  Many biopharmaceutical companies are also bolstering their pharmacovigilance efforts by expanding their Phase IIIb clinical trial programs, which are conducted during the regulatory review process.  This approach gives companies the opportunity to gather additional safety and efficacy data – allowing them to gain a greater understanding about their products’ characteristics in real-world settings so they can work with the agency throughout the review process to refine a product’s safety profile. 

Clinical pharmacovigilance and risk management experience
ORICENT also has specific regulatory expertise in pharmacovigilance, including the European Union Risk Management Plan (EU-RMP) and the FDA’s guidances on Premarketing Risk Assessment, the Development and Use of Risk Minimization Action Plans (RiskMAP), and Good Pharmacovigilance Practices.Pharmacovigilance is essentially risk assessment and management. Ethics is at the core of this function because it is the Company’s responsibility to share the data on adverse reactions with regulatory authorities.

The Pharmacovigilance practice spans two key areas:

  • Post marketing surveillance
  • Clinical trials

Post marketing surveillance is meant to be carried out amongst a huge population. In comparison, Clinical Trials are within a controlled population and are therefore easier to be recorded and monitored.

Drug Safety encompasses all aspects of drug reaction right from side effects, adverse effects, lack of efficacy, or any response reported once a medication is administered to a patient. 

The Pharmacovigilance team works closely with the Regulatory and Quality Assurance teams to address any product related issues and, if need be, conduct health hazard assessment. 

Oricent has a Drug Safety Assessment and Reporting team in keeping with global regulatory requirements.
Subsequently, the reports are submitted to regulatory authorities as per the necessary requirements.Oricentpractices recording of adverse events, which is based on the standard adverse event format, which includes the CIOMS form which is based on global standards in reporting. The adverse events are collected through various media like the toll-free number at our call center, emails, faxes, and other communication channels. 

We are setting up training processes to ensure that all employees who may be in a position to capture Adverse Drug Reactions are well equipped to do so. Besides, the proactive component of Pharmacovigilance is to continuously monitor and conduct signal detections for certain adverse events which may get reported on a frequent basis