Physicians can play a crucial role in helping to identify and report side effects and adverse events as a result of medication usage. Those that oversee this work and investigate the risks and the safety of drugs currently on the market and in clinical trials are professionals in the field of pharmacovigilance.
It used to be that once a drug was approved by the FDA and hit the market, the safety checkpoints were considered met. However, now with so many drugs on the market and the potential for drug interactions, as well as the possibility of adverse effects that may not have been observed during clinical testing, there is the need for continued drug surveillance.
The field is expected to continue to grow rapidly with the growth of the pharmaceutical and biomedical industries. Physicians in this field collect more information regarding adverse outcomes or side effects of drugs and report them so that additional clinical studies can be designed, drug labeling can be revised, or the drugs can be pulled from the market if necessary.
There are positions working for research organizations overseeing side effects in clinical trials, as well as monitoring for adverse effects for drugs currently being prescribed. Positions in the field include more laboratory facing positions such as drug safety scientists or medical directors of clinical trials, as well as physician and patient facing positions, such as medical advisors.
Drug Safety Scientist
▪ Monitor the safety of medications currently in clinical trials or ‘real world’ use
▪ Ensure that medication labels appropriately display medication side effects
▪ Discuss drug side effects or concerns with physicians
▪ Conduct continuing medical education activities regarding drug action and side effects
▪ Handle patient enquiries on drug safety issues
▪ Pharmaceutical company
▪ Contract Research Organization
▪ Biotech company
|▪ Pharmaceutical company|
Job responsibilities in the field of pharmacovigilance can include positions as a drug safety scientist, medical director, or medical advisor, among other roles. For physicians who wish to maintain contact with clinical providers or work in particular areas, such as clinical research, pharmacovigilance and drug safety positions provide a diversity of options of varying supervisory levels.
Various job responsibilities may include:
- Reporting adverse side effects of medications via entry of data into drug safety reporting databases
- Identifying hazardous medications for removal from the market
- Monitoring the safety of medications currently in post-marketing trials
- Examining adverse events in clinical trials to determine patterns or design flaws
- Protecting patients against harm due to medication adverse effects
- Investigating risks associated with particular medication usage or drug interactions
- Ensuring that medication labels appropriately display medication side effects and potential risks and benefits
- Following up on drug safety concerns reported by other physicians, including collection of details of adverse outcomes for report to regulatory bodies
- Traveling to conferences to learn about new areas of drug discovery and development
- Handling patient enquiries on drug safety issues
- Conducting continuing medical education activities regarding drug action and side effects
Work Environment and Schedule
The work schedule and environment of pharmacovigilance physicians can vary widely depending on which sector of drug safety the work is focused on. Medical advisors may have more travel and time outside of the office communicating with other healthcare professionals and attending educational events, while those working in clinical trials may have more set hours evaluating adverse effects and submitting reports for review by regulatory bodies.
Physicians with subspecialty training may find that working for a contract research organization investigating a particular drug in their former area of practice may allow them to most effectively use their expert knowledge. Positions can vary in supervisory and administrative skills necessary, and the environment can vary from working in an office environment to more of a clinical or laboratory setting. In many positions, there may be a great deal of data analysis and review, report writing, and collaboration with others including fellow physicians, scientists, pharmacists, technicians, or government officials.
Required Skills and Training
There is a hierarchy of skills and training in pharmacovigilance, and therefore those that wish to obtain the most supervisory roles need years of experience in the field. Even young physicians should not have a problem obtaining a position in the field, but may have to work their way up to senior level director positions.
Required skills include:
- Knowledge of pharmacologic principles including pharmacokinetics and pharmacodynamics
- Understanding of clinical trial design and the drug development process
- Familiarity with FDA processes and regulations
- Logical thinking with an ability to review and interpret medical data
- Communication and leadership skills
- Clear understanding of biostatistics
Residency, Licensure, and Training Requirements
Board certification and licensure are generally required for medical supervisory or consulting roles. For other roles in pharmacovigilance, a degree in health-related field is generally required, with preference for advanced degrees including PhDs, MDs, and PharmDs.
Is This a Career for You?
Physicians with an interest in serving as a type of public safety officer, protecting the public from drugs that could be potentially harmful, may find a career in pharmacovigilance very satisfying. Instead of advising patients on an individual basis, these physicians have taken on the role of protecting the public at large by investigating medications that may be causing adverse effects or risks that the public should be made aware of. Physicians with a strong understanding of pharmacology, ability to review data, and those that enjoy working in the realm of healthcare regulation may find this job very fulfilling.
Physicians who prefer to avoid the administrative or data tasks required to analyze side effects, follow up on them, and ensure that they are reported to regulatory bodies may find jobs in pharmacovigilance are not a solid fit for them. Those that prefer to avoid hierarchical structures or very regimented work guided by protocols would not be well suited for drug safety or pharmacovigilance.
The field can be rewarding for those with matched talents who feel they are contributing to overall societal safety and who see the value in healthcare providers being involved in ongoing drug safety.