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Safety and Leadership in FDA Division of Pharmacovigilance

Alicia Lopez, PharmD and Vicky Chan, PharmD, BCPS, US Food and Drug Administration's Office of Surveillance and Epidemiology Division of Pharmacovigilance, Silver Spring, MD

This article reflects the views of the authors and does not necessarily represent FDA’s views or policies.

The US Food and Drug Administration's Office of Surveillance and Epidemiology – Division of Pharmacovigilance (DPV) is staffed by clinical pharmacists, including psychiatric pharmacists, as Safety Evaluators (SEs), who have the unique opportunity to influence patient care at a magnitude not found in many other pharmacy practice settings. SEs are part of a multi-disciplinary team responsible for the surveillance of adverse drug events (ADEs) associated with FDA-regulated drugs by evaluating and interpreting information from the FDA Adverse Event Reporting System (FAERS [MedWatch reports from drug companies, clinicians, and patients]), medical literature, and other relevant data sources. SEs use postmarketing data to discover rare and serious ADEs that were not identified during the drug development process. This evaluation requires the SE’s clinical and scientific expertise in determining the adequacy of clinical documentation, the severity of the ADE, the possible drug-event causal relationship, and the potential risk to public health. Safety evaluations may lead to regulatory actions intended to improve public health outcomes by promoting the safe use of FDA-approved drugs (e.g., new boxed warnings, drug safety communications, drug recalls).

Most SEs are residency trained and many are board certified in specialty areas, including psychiatric pharmacy. SEs often serve as preceptors for pharmacy students nationwide with the goal of familiarizing the student with the role of DPV in postmarketing safety. Pharmacy students have the opportunity to assist DPV in the mission of protecting public health by detecting and analyzing postmarketing ADE data, identifying drug safety concerns, and recommending actions to improve drug safety.

Medical Science Liaison (MSL)

Amen I Ogunmekan, PharmD, BCPP, Medical Science Liaison, Alkermes, Lee Summit, MO

Usually when someone finds out that I am a pharmacist, they immediately assume that I work at a retail pharmacy such as CVS or Walgreens. Then I often respond by saying no, I work at XYZ as a Medical Science Liaison (MSL). Then I proceed to explain what a MSL does. Most times I get the same response, “pharmacists can actually do that?” My journey to becoming a MSL might be somewhat unique in the sense that I knew I always wanted to be in the industry, but I really wanted to experience residency training, clinical practice, then later in my career switch to industry. Most pharmacists who become a MSL or pursue any another industry role, often do an industry experimental rotation, pursue a summer internship with a biotech company, and then complete an industry focused fellowship.

There might be some negative stigma associated with the MSL role for students or clinicians who are not familiar with MSLs and often confuse MSLs with a sales executive. MSLs usually are scientific experts in both pre-clinical/clinical data and share their knowledge with the medical community in their respective therapeutic space. MSLs are also part of advisory boards, journal clubs, publications, conference planning, and so much more.

I encourage students who are interested in this nontraditional role of pharmacy to get involved in organizations such as Industry Pharmacists Organization, network with pharmacists currently in this role, and, most importantly, research the various job opportunities in biotech to find what matches your career goals.

Medical Education Director (MED)

Clinton W. Wright, PharmD, BCPP, Medical Education Director, Medscape Education, Nashville, TN

After a brief stint in prison (as the psychopharmacologist for the Texas prison/adjunct faculty at the University of Houston COP) and over 20 years in the pharmaceutical and device industries, I have settled into the adult learning/medical education space. As a Medical Education Director (MED) in CNS, I am responsible for all content for programs to which I am assigned. This includes the development of the presentation, including slides, to all steps leading up to the launch of the program. I have worked on individual programs and on large conferences with national and international experts. These programs have included text, audio, and video formats. Some unique roles I’ve had are casting director and animation consultant. I select actors who will portray clinicians and patients in clinical scenarios. There are two types of animation that may be incorporated into our programs, 2-D and whiteboard animations. I oversee the script and design of these animations from storyboard to production. Another role that I have added to my professional life is that of tutor, both privately and through an agency for candidates that will sit for the NAPLEX. I find this one of the most rewarding activities I have done in the last 30 years. I teach first time test takers and those who have failed numerous attempts. The learner must shift from a “cramming” mindset to that of an adult learner wishing to retain the material. My need for creativity and learning are fully sated. Although nothing is formalized yet, Medscape Education is currently working toward offering a rotation site for students interested in medical education. I am happy to hear from those who are interested and will pass that along to our management team.

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