When new drugs enter the market, they need to be tested for safety. It has to be declared safe and competent and not just restricted to clinical trialsIn spite of FDA regulations and guidelines for the drug to be marketing the pharmacovigilance team needs to supervise and monitor the drug to label it safe for consumption to enhance better health. This pharmacovigilance or drug safety requires trained manpower to study the drugs and their safety. Drug safety associate studies the drug, its effects and depending upon the analysis, terms it safe or unsafe for patients.
Drug Safety Associate is a career in the field of Pharmacovigilance. This is a field that helps in discovering, estimating, comprehending adverse effects of drugs both long and short-term and also the side effects. It requires detailed compilation of clinical data, investigation, and estimation by Drug safety associate. He also Monitors and analyzes the drug and its effects.
Role of a Drug Safety Associate
- Monitors day to day activities of pharmacovigilance department
- Overview any adverse events occurred, identified or reported
- Liaise with healthcare service providers for detailed drug safety and efficiency aspects
- Ensure the identification of all safety reports received from investigational sites or from post marketing sector and these are reported according to ICH-GCP standards and standard operational procedures.
- Meticulously organizing collected reports based on seriousness and effectiveness of the drug initially.
- Consistency and accuracy, legibility in assessing adverse reaction reports
- Take appropriate decisions based upon thorough knowledge of FDA & ICH-GCP standard regulations.
- Clearly and effectively communicate with clinical physicians associated with drug safety and ability to evaluate case report forms
- Ability to distinguish and analyze the ratio of risks and benefits of any drug to be marketed
A career in drug safety and pharmacovigilance begins as a Drug Safety Associate, Coordinator, Scientist, and Officer. Most Drug Safety professionals excluding drug safety physicians begin the career as a Drug Safety Associate or Drug Safety Officer.
The drug safety associate is responsible for case processing. Case processing mainly involves recording patient reported side-effects of pharmaceutical products into a database. This database is evaluated by risk management teams.
Job options for Drug Safety Associates
After working as a Drug Safety Associate for some time, the next job progression for drug safety associates offers two options.
- The Line Management Route - senior drug safety officer, manager, and director
- Technical Route-this includes signal detection, risk management and epidemiology roles such as senior pharmacovigilance scientists, risk management specialists and senior vigilance managers.
Signal detection expertise requires higher scientific knowledge than processing roles. The aspiring candidates are expected to have the ability to identify trends in data reveal the fundamental reasons for drug side-effects. These skills require experience and training and pursuing courses conducted by Pharmacovigilance Association can be beneficial.
Risk management roles in drug safety are expert positions. They are responsible for detecting and evaluating health risks of pharmaceutical drugs identified by case processing and signal detection teams. They create drug reports based on risk/benefit analysis. They make recommendations to drug safety physicians on the course of action to be taken in prescribing drugs to patients.
However, the transition to specialized career options for drug safety associates can be challenging due to high competition for senior roles, lack of opportunity for correct exposure to required skills for technical roles. If a Drug Safety Associate is willing to put effort to gain knowledge and practical experience, then this could be an extremely rewarding career for him.