The Sanofi Pasteur / Wilkes University two-year Industry Pharmacy fellowship program is a comprehensive experience for Doctor of Pharmacy graduates to gain exposure in pharmacovigilance for vaccines.
Sanofi Pasteur, the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines. Our driving goal is to protect people from infectious diseases by creating safe and effective vaccines.
The Swiftwater, PA, site offers a beautiful campus in the scenic Pocono Mountains and a unique opportunity to encounter the full life cycle of a vaccine from early stages of research and development to manufacturing and post-marketing surveillance. With headquarters in Lyon, France, the Fellow will interact with colleagues at a global level. The Fellow will also gain exposure to other functional areas based on individual interest including Pharmacoepidemiology, Signal Detection, Regulatory Affairs, Medical Affairs, Clinical, and Biostatistics. The Fellow is appointed as adjunct faculty at Wilkes University. Academic opportunities include didactic teaching, precepting pharmacy students, distinct presentations, and projects. The Fellow will be a primary resource to the student chapter of Industry Pharmacists Organization (IPhO).
The pharmaceutical industry is responsible for the monitoring, assessment and communication of safety information throughout a product’s lifecycle. The activities associated with this responsibility are referred to as pharmacovigilance. At Sanofi Pasteur, the Global Pharmacovigilance and Epidemiology (GPE) Department is responsible for these activities. The aims of pharmacovigilance are to enhance patient care and safety in relation to the use of pharmaceutical products by ensuring that emerging safety signals are proactively identified and appropriate actions are taken to ensure the benefit/risk profile remains favorable. Pharmacovigilance is a growing and thriving field within the pharmaceutical industry as regulations continue to expand and evolve and the need for knowledgeable and qualified personnel increases.
To provide the Fellow with training and experiences in global pharmacovigilance that will prepare them for a challenging and rewarding career in the pharmaceutical industry.
During this two-year program, the Fellow will:
- Understand the mission of a pharmacovigilance department and the role of GPE in clinical development and product lifecycle management
- Become knowledgeable in current global pharmacovigilance regulations and guidelines, including US and European regulations
- Develop the ability to think strategically with a global pharmacovigilance and regulatory perspective
- Expand his or her medical and scientific knowledge of products within various therapeutic areas
- Actively participate in:
- Safety surveillance and signal detection
- Risk management
- Preparation of various regulatory documents (e.g. Periodic Safety Reports, Product Label Updates, and Risk Management Plans)
Transition & Integration
An on-boarding period is provided early in the fellowship to ease the transition of the Fellow into a pharmaceutical company with global reach. Once the learning objectives are met and initial trainings are completed, the Fellow will have the opportunity to gain knowledge on topics ranging from Audit Readiness to Zika Virus. Throughout the program, the Fellow is mentored by a dedicated team.
The Fellow will acquire a comprehensive foundation of the major concepts of pharmacovigilance, including global regulations and guidelines applicable to adverse event reporting, signal detection, and risk management. The Fellow will be able apply their newly acquired knowledge to make visible and meaningful contributions to professional project teams.
The Fellow will contribute to global projects involving multi-disciplinary teams.
The Fellow will have opportunities to strengthen interpersonal skills by interacting with colleagues of diverse backgrounds. The Fellow’s ability to clearly articulate thoughts and concepts effectively will be fortified through these interactions, as well as through regular professional presentations at Sanofi Pasteur and Wilkes University.
The Fellow will learn about globally recognized pharmacovigilance tools. The Fellow will also become familiar with the company safety database, signal tracking system, and electronic document archival system. Their ability to critically analyze and interpret scientific and clinical information, as well as their medical writing skills, will be refined.
The Fellow will be introduced to Sanofi colleagues in Bridgewater, NJ, and Genzyme colleagues in Cambridge, MA, and encouraged to foster professional connections, both locally and globally.
Natalya Romanyak, PharmD
Judith L. Kristeller, PharmD
Stark Learning Center
Philip Loscombe, PharmD
PV Science Manager
Melissa Rossi, MHP
Global PV Science Lead
Fellowship Program Lead
Tamala Mallett Moore, MD
Therapeutic Area Lead
Owen Haney, PharmD
Michal Borawski, PharmD
Periodic Reports Manager
- Applicants must have a Doctor of Pharmacy degree from an ACPE accredited school of pharmacy. Candidates must have strong written and verbal communication skills and an interest in pursuing a career in the biopharmaceutical industry. The fellowship will commence in July of each year.
- All candidates must have authorization to work in the United States throughout the duration of the two-year fellowship. No visa sponsorship will be provided.
- The application period for the 2018-2020 Fellowship program is closed.
- For more information, please contact Philip Loscombe, PharmD, Fellowship Director at email@example.com.