Opportunities for a Fellow
The Fellow will have the opportunity to develop expertise in various pharmacovigilance operational activities including Periodic Safety Report (PSR) planning, PSR coordination and Literature Surveillance. The Fellow will also gain exposure to other functional areas based on individual interests and rotate across various Sanofi Global Business Units.
The Fellow is appointed as adjunct faculty at ÐÓ°ÉÖ±²¥app. Academic opportunities include didactic teaching, precepting pharmacy students, global presentations and projects. The Fellow will be a primary resource to the student chapter of Industry Pharmacists Organization (IPhO).
About the Fellowship
- The Fellow will develop expertise in various pharmacovigilance operational activities including Periodic Safety Report (PSR) planning, PSR coordination and Literature Surveillance.
- The Fellow will develop a strong understanding of worldwide regulatory requirements for PSRs and be able to guide product teams and stakeholders to ensure the Patient Safety & Pharmacovigilance (PSPV) department remains in regulatory compliance.
- The Fellow will lead and manage the cross-functional coordination of PSRs and work with worldwide affiliates for PSR planning activities.
- The Fellow will gain a strong understanding of how the global literature is surveilled for relevant safety information on Sanofi products including individual case safety reports and safety information impacting the benefit-risk profile of global products.
- The Fellow will have the opportunity to rotate across the various Sanofi Global Business Units within PSPV.
- The Fellow will have the opportunity to gain exposure to other functional areas based on individual interest.
To become a valuable member of the PSPV team through technical training and hands-on experiences in various PSR and Literature Surveillance areas ensuring PSPV is meeting worldwide regulatory periodic report requirements and ensuring patient safety.
During this two-year Pharmacovigilance Fellowship, the Fellow(s) will be involved in the following functions:
Periodic Reports Expert
- Is the centralized PSPV expert on the regulatory framework for Global PSRs.
- Leads and manages the cross-functional coordination and authoring of PSRs through project management activities.
- Participate in Health Authority assessment report responses through collaboration with the transversal stakeholders.
Periodic Report Planning Regulatory Expert
- Will be the expert on worldwide regulatory requirements concerning PSRs working with worldwide affiliates to build the global PSR planning schedule.
Literature Surveillance
- Oversees the screening and adjudication of global literature relevant to Sanofi products.
- Coordinates ad-hoc requests for literature in support of various safety analyses.
Periodic Safety Reports and Literature Surveillance Fellowship
Michal Borawski, PharmD
Steven Baldwin, PharmD
Elizabeth Shih, PharmD, RPh
