Case Management and Process Expert

Job description

In this transversal role, the Case Management and Process Expert (CMPE) is in charge of the following roles, responsibilities and activities:

·  Subject Matter Expert (SME) for specific products and studies and point of contact for case processing processes
·  Performs Medical Review (MR) activities as per pre-defined activity and job-role in AEGIS safety database, for specific products and/or clinical trials defined in their scope.
·  Case Management Audit and inspection representative, in close collaboration with GPV Audit and Inspection Readiness group.
·  Key contact for Clinical Studies Operations – for processes, tools and related QDs inputs
·  Support to vendors on DECA/MR, and medical queries ad hoc with the support of the Case Management and Flow Expert (CMFE).
·  Provides answers to the questions on process coming from all other entities / vendors, in coordination with Case Management units.
·  Safety data Exchange Agreement and PV Intelligence interface.
·  Point of contact for Coding activities – review of coding discrepancies during reconciliation, update of MedDRA dictionary version and implementation, autocoding functionality in AEGIS
·  Elaboration and maintenance of case processing related Quality Documents. Involved in the review of all Case Management related QDs.
·  AEGIS User manual ownership, maintenance and communication
·  Case management representative for CAPA elaboration related to case processing, in collaboration with the Case Quality group and GBUs.
·  Development and delivery of training on case management and key related processes to vendors (as well medical and technical, as necessary, with the GBUs representative)
·  AEGIS Super User: strong knowledge of AEGIS and ability to understand the workflow and the regulatory requirements.
·  Participation to operational meetings internal or with vendors
·  Ensure the case processing and related activities homogeneity within GBU, and adequate communication as necessary.
·  Preparation of products/studies transition to GBU

Qualifications:

Minimum Qualifications:

·  Degree requirement: PhD in a scientific field, Bachelor's of Pharmacy, PharmD, or MD (or international equivalent)
·  Requires 3+ years of pharmacovigilance experience in industry

Preferred Qualifications:

·  Experience working at FDA is a plus
·  Experience working with third party vendors and licensing partners desirable
·  Specialization knowledge of medical terminology, diagnosis and treatment
·  Robust experience with pharmacovigilance databases, WHODrug and MedDRA coding
·  Strong knowledge of Clinical Development environment and tools
·  Able to communicate, verbally and in writing in English, and to understand complex medical concepts.
·  Ability to present and lead meetings in English
·  Able to prioritize workload to ensure individual and group compliance with regulatory timelines
·  Ability to conduct projects in a regulatory and constraint environment
·  Ability to adapt to a moving environment and provide high standard of quality
·  Ability to work in a multicultural environment

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.