In this series, we highlight specific functions or departments within typical pharmaceutical company organizations. We also feature the perspectives of women working in these different functions and their career journeys.
The Safety Science function within pharma companies is charged with safeguarding patient safety along the entire lifecycle of a medicine. While the safety of a medicine can be studied in a clinical trial, much of the knowledge about the safety of a medicine is gathered after it is launched in the marketplace as patients are using the medicine in routine care.
This function is responsible for implementing a pharmacovigilance system to monitor suspected adverse events or side effects reported in conjunction with the company’s medicines. Adverse events reported to the pharma company may need to be investigated, and regulatory bodies may also request that companies investigate adverse events.
Safety Scientists initiate steps to address and remediate situations in which patients taking the medicines may be at risk. Identified new side effects may result in a label update so that patients and providers are aware of the risk.
Safety Science departments may be called by some of the following names:
- Pharmacovigilance and Risk Management
- Drug Safety
- Clinical Safety and Pharmacovigilance
Some of the people working within Safety Science may hold position titles such as:
- Drug Safety Associate
- Medical Safety Physician
- Drug Safety Scientist
- Safety Operations Specialist
- Drug Safety Coordinator
- Pharmacovigilance Scientist
- Medical Director
The education of people in the Safety Science function may include degrees in:
- Pharmacy
- Medicine
- Pharmacology
- Nursing
- Health/Biomedical/Life Sciences
Function Feature:
Jill Martin, MD, MPH
Associate Group Medical Director, Safety Science, Genentech
1. Please describe your educational and professional background up to your current role.
I graduated from Boston University School of Medicine with a US Navy scholarship. I then spent 5 years with the US Navy as a General Medical Officer repaying my commitment. During that time, I completed a transitional internship chosen so that I could learn about a number of different specialties. I was then a physician to a Marine unit of about 250 with whom I deployed in 2004-2005. My final 2 years with the Navy was spent at our Preventive Health clinic where I also completed my Master’s in Public Health at night from San Diego State University. I moved away from patient care due to my interest in public health policy. I then completed the practicum portion of a General Preventive Medicine/Public Health residency within the Los Angeles Department of Public Health. I worked at the California Department of Public Health for 1.5 years, focusing on public health training programs. I lost my funding, which happens frequently in public health, and then moved to the east coast to complete a pharmacovigilance fellowship through Merck. After that, I accepted a position in California with Genentech. I started as an entry-level safety scientist on an oncology program and then moved to an ophthalmology product after about 18 months. Over a period of 3 years, I was promoted twice and became the safety science manager for the product. Then, after disappointing PhIII results, the program was closed, and I looked for a new role. The department was going through a redesign and my new role was a chance to assist with developing the vision for the new organization.
2. Briefly describe your current role (responsibilities, day-to-day tasks, etc.).
About 18 months ago, our department moved towards a matrix management organization. The main focus of my role is on the development of my direct reports within the safety science organization along with working closely with the safety science managers of products in a specific therapeutic area in order to allot adequate resources so that they are able to complete designated tasks for the product. The resourcing needs could be urgent, such as in the case of a health authority question, or projected over a longer period of time, such as when a filing is scheduled for next year. Because the experience of my direct reports span new-to-industry to industry veterans, the training I provide to my direct reports can span from how to define an event as an adverse event to helping teams assess the best data source for their signal evaluations.
3. What skills/attributes are needed for a candidate to excel in your function?
While I do not think it is necessary to have been a safety science product manager to fill my current role, I do think that having a good understanding of drug development is helpful. Knowing what types of reports or event surveillance is needed at each step of a molecule’s lifecycle, from first-in-human to post-marketing, is necessary to guide the development of our scientists and to understand the varying resourcing needs a team may have now or in the future. To work within a safety science department, having clinical experience is helpful, whether that be as an MD, RN, or PharmD. Understanding how patients experience medical treatment and their access to medicines is beneficial when reviewing adverse events that are submitted or when determining what type of data can be retrieved as you help develop a clinical trial.
4. What do you find most challenging about your current role?
For this current role, balancing the needs of a team with the currently available resources, or lack of resources, has been difficult. However, when working as a safety science product lead, my challenges at times were when I had to be the bearer of bad news to a team, in that the safety profile of the product had to be changed to incorporate a possible adverse drug reaction. This news was, of course, important to our patients but could be tough for the team as it could change filing or marketing strategies. I found that relying on strong data to support my decision as well as providing the team with possible risk mitigation options for that adverse event could facilitate a smoother conversation.
5. What do you know now that you wish you knew earlier in your career journey?
I wish that I had the understanding that one’s career is a journey. I felt a lot of pressure to know what I wanted to do with my life when I graduated college and even more so when I graduated medical school. It took me years to find a field with which I connected. Drug pharmacovigilance combines my clinical experience with my knowledge of epidemiology. But, after being in this field for a few years, I also realize that my journey does not necessarily end here. Many of my colleagues have been able to translate their skills and experiences to new roles within the company or externally successfully.