Periodic Safety Reports and Literature Surveillance 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.