Job title:Case Intake Expert

About the job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate Progress. Join our Patient Safety and Pharmacovigilance (PSPV) Operations team, as Case Intake expert within the Regional Intake & Submission team, to ensure the collect, registration and submission of French Pharmacovigilance (PV) cases.

This function is key to ensure the business continuity and the proper registration into the PV database of any safety information received locally, that is the basement for the assessment of the safety profile of the Company products. The team interacts with multiple stakeholders at local and corporate level and the case Intake Expert, as key contact, works in close collaboration with the French PSPV Team and with vendors for outsourced activities.

The French PV operation team is a dedicated and engaged team, with the ambition to support new programs, new product launches, new partnerships and the local implementation of global projects, to ensure that safety information is properly transmitted and registered for further analysis.

Main responsibilities:

The primary function of the Case Intake Expert (CIE) is to

• Manage Safety Vigilance information received at the point of intake by reviewing the source document (if applicable) and extracting the PV data before sending the cases to the vendor for handling (translation/registration/distribution)

• Answer questions from the stakeholders received at the point of intake regarding PV cases

• Perform or oversee the accurate management of the intake mailbox and handling of PV cases if outsourced to the vendor and oversee the submission activities specific to the country they support. The CIE is  responsible for ensuring guidance and oversight of intake and submission activities performed by the vendors

• Ensure any administrative activity related to the intake and other case management process is performed, including electronic archiving when appropriate

• Interact with the French PSPV team as well as with other departments such as affiliate Medical Information, Quality, Legal, etc… or global departments in order to ensure that safety Vigilance data is accurately received and processed in the global PV database

• Contribute to the lateness investigations when needed or oversight of vendor

• Provides support to the Case Intake and submission Manager in relation to project management

About you

Experience:

• 3+ years of experience in healthcare-related field and/or in patient-care activities, experience in pharmacovigilance and working with third party vendors and licensing partners desirable

Education:

• Registered Nurse, Pharmacist, PharmD or other advanced medical/scientific/pharmacovigilance degree

Soft and technical skills:

• Broad knowledge of pharmacovigilance, regulatory and medical terminology, medical-related skills, robust experience within pharmacovigilance, the PV databases, computer literacy, especially Microsoft Office programs. Able to work in a high volume, fast paced environment and independently prioritize workload to ensure individual and group compliance with regulatory timelines

Languages:

• French bilingual; English: able to communicate, verbally and in writing, complex medical concepts in English

PursueProgress.DiscoverExtraordinary.

Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover Extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

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