Mirza I. Rahman, MD, MPH, FACPM, is the Senior Vice President & Chief Global Pharmacovigilance (GPV) Officer, Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC).
Six years ago, the American College of Preventive Medicine (ACPM) started a collaboration with Otsuka Pharmaceutical Development & Commercialization, Inc., to create the ACPM – Otsuka Pharmacovigilance Physician Program (PPP). This two-year pharmacovigilance training program for physicians, was designed to develop a broad expertise in clinical drug safety and pharmacovigilance (PV) in recent to mid-career Preventive Medicine physicians.
Our philosophy at Otsuka is “Learning by Doing”, and the keys for success are compliance, collaboration, & continuous growth. In the ACPM – Otsuka PPP, trainee physicians use their preventive medicine skills (See ACGME Competencies & Milestones) to support the research and development of pharmaceutical drugs and device products worldwide. In addition, these trainee physicians are encouraged to seize the initiative and explore opportunities outside of PV that are of interest to them and are of benefit to Otsuka.
Select ACGME Preventive Medicine Competencies & Milestones:
- Work in inter-professional teams to enhance patient safety
- Work effectively as a member or leader of a health care team
- Act in a consultative role to other physicians and health professionals
- Communicate effectively – good interpersonal and communication Skills
- Inform and educate populations about health threats and risks
- Evaluate population-based health services
- Analyzes surveillance data to identify appropriate targets for individual, community, and/or systems interventions.
- Independently analyzes large data sets
The World Health Organization’s (WHO) definition of Pharmacovigilance is “The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem”. In the PPP, the trainee physicians seek to develop expertise in risk management and safety surveillance of assigned products, including assessing safety information, performing safety signaling and data mining, developing aggregate reports & risk management plans, and preparing health authority responses.
Currently, there are seven trainee physicians in the PPP, with another four expected to join in the third quarter of 2020. Additionally, eight physicians have completed the program and have obtained senior roles in PV at the FDA or in various pharmaceutical companies, while three have pursued careers outside of PV.
With the advent of the COVID-19 pandemic, given their Preventive Medicine & Public Health training, the ACPM – Otsuka PPP trainee physicians were asked to join the Medical Safety COVID-19 Team, to help the company manage its response to this crisis. They took the initiative to fulfill this unmet need, along with their colleagues in a similar developmental program for pharmacists, and meet twice-weekly with a group from Human Resources, Facilities Management, and Communications, while being coordinated by Ms. Michelle Lebo in the PV department, and supervised by the Global Head of Medical Safety, Dr. Vinu George, and myself.
The team immediately got to work conducting a needs assessment and in less than a week, they had prepared a comprehensive COVID-19 FAQs document. These FAQs addressed several of the unanswered questions as this pandemic started, and it is updated on a weekly basis. We are now several weeks into this quarantine, with a resultant working from home (WFH) policy, and this FAQ document has grown to be a 15-page missive that is shared with all of Otsuka Pharmaceutical sister companies around the world.
Additionally, the Medical Safety COVID-19 Team has begun to participate in the early planning of the Otsuka Return to Work Task Force, which is helping to ensure that employees can return to work safely. The team is also responsible for helping to prepare me to present the medical updates that I give on a regular basis to our North American affiliates and to the Otsuka Executive Leadership Team, chaired by our President & CEO, Mr. Kabir Nath. The willingness of these Preventive Medicine physicians to take up the challenge of proactively dealing with this difficult COVID-19 pandemic’s impact on the organization, truly embodies the Otsuka philosophy of “Learning by Doing”.
The work of the Otsuka Global PV team continues unabated, even as we work from home, because regulatory agencies around the world continue to expect total compliance with case reporting, responses to their requests, and inspection readiness, as some countries are starting virtual inspections. Thus, in addition to urgent responses required by COVID-19, the trainee physicians have continued their usual duties in the Global PV department to protect patient safety and public health.
They do this by evaluating the collected safety data to ensure that there is a positive Benefit:Risk ratio of the products they work on, and by appropriately managing the safety profile of those products, under the guidance and direct mentorship of more experienced physicians in the department, while developing expertise in the following Global PV competencies.
Select GPV Competencies:
- Signal Detection
- Medical Review
- Labeling Changes
- Aggregate Reports
- Health Authority Responses
- Risk Management & Minimization Plans
At Otsuka we are on a mission to create new products for better health worldwide. We are dedicated to patient safety and emphasize that “Drug Safety is Everyone’s Business”. We also have a unique culture that includes:
- Thinking Differently
- We challenge people to think unconventionally, to be creative, innovative and unorthodox in trying to address unmet needs.
- Having the commitment, vision, and fortitude to never give up.
- We foster diversity of thought, cultural background, experience, and above all, diversity of discussion and debate.
We frequently note that the keys to success here in Otsuka’s Pharmacovigilance Department include seizing the initiative, along with:
- Compliance: Completion of all work in a compliant and timely manner, especially regulatory and training activities
- Collaboration with team members to perform activities required to manage global product safety
- Continuous growth and improvement by learning through doing, training courses, mentoring, and coaching
Despite the pain, suffering and loss that the COVID-19 pandemic has brought to the world, it has created an opportunity for growth and development and for thinking and doing our jobs differently. When preparation collides with opportunity, the resultant release of energy, when efficiently harnessed, leads to a successful outcome.
I would like to thank the ACPM-Otsuka PPP trainee physicians, Drs. Zachary Williamson, Celia Ezidiegwu, Michael Jan, Lia Kostiuk, Lahila Ojeda, & Alisha Thomas for their perseverance and for seizing the initiative and responding to this crisis with grace under pressure, which is the Hemingway definition of courage! And they are most certainly building the foundation for a rewarding career in the pharmaceutical industry.