Periodic Safety Reports and Literature Surveillance Fellowship

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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 Wilkes University. 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).

Application Process

The Periodic Safety Reports and Literature Surveillance Fellowship will be recruiting one Fellow.

Eligibility

Fellows for the Wilkes University Pharmaceutical Industry Fellowship Program are selected on a nationally competitive basis.

Applicants must have a Doctor of Pharmacy degree from an ACPE accredited college of pharmacy before the beginning of the Fellowship.
Candidates must have strong written and verbal communication skills and an interest in pursuing a career in the pharmaceutical industry.
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.

Application Procedure

Please submit all application materials to PeriodicReportsFellowship@sanofi.com.

Interview requests will be accepted on a rolling basis from Oct. 23 through Dec. 13. Early submission is preferred.

Applicants must include the following application materials:

Letter of Intent (LOI)
Curriculum Vitae (CV)
Two letters of recommendation (LOR) must be submitted directly by the letter writer to PeriodicReportsFellowship@sanofi.com no later than Dec. 15.

Address your LOI & LOR to:

Sanofi Vaccines Patient Safety & Pharmacovigilance
1 Discovery Drive
Swiftwater, PA 18370

Interviews and Selections

Interviews for selected candidates will be conducted virtually in October and November.

Recognizing that the choice of a Post-Doctoral PharmD Industry Fellowship is an important decision, Wilkes University in conjunction with the Academic Industry Fellowship Alliance (AIFA), has agreed to extend offers for Fellowships no earlier than Dec. 13.

About the Fellowship

Overview

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.

Goal

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.

Objectives

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.