Sanofi Group Pharmacovigilance & Medical Quality Documents Coordinator in Waltham, Massachusetts
Manage the Global Pharmacovigilance (GPV) and Global Medical Quality Documents (QDs) to enhance compliance with applicable Regulations in line with the quality Strategy and Vision of Sanofi. Deliver the necessary expertise, processes to ensure proper management of the Global Quality Documentation. The role ensures transversal interactions with the Sanofi organization (GPV, Global Medical, Global Business Units (GBUs), Countries, Quality groups from Clinical, Regulatory, Countries, Global Quality).
Ensure the preparation and maintenance of Global Pharmacovigilance (GPV) and Medical Quality documents (QDs) in line with global quality standards
Promote a single consistent approach in Sanofi processes
Contribute to the establishment and monitoring of the annual QD plan.
Ensure Sanofi architecture of QDs is applied
Manage Quality Documentation with data consistency across different tools
Foster simplification and avoid redundancy of Quality Documents
Manage Quality Documentation with data accuracy and compliance to writing rules
Ensure timeliness and quality of Quality documents in the Electronic Document Management System:
Ensure documents are following the correct workflow steps
Perform a QC step of each document
Monitor workflow steps of each document until approval. Remind authors, reviewers and approvers as needed.
Communicate on the approval and effective dates of Quality Documents
Ensure required or essential quality documents are authored in due time in collaboration with respective Subject Matter Experts (SMEs).
Ensure the delivery of training of the concerned QDs by creating training link in the Learning Management Systems(s) and preparing e-learning material with SMEs
Contribute to the preparation of Quality Documents metrics and Key Performance Indicators
Support inspections and audits by providing required data on due time, participating to interviews, contributing to root cause analysis and CAPA proposal
Seek further understanding of the customers' requests to ensure provision of correct information
Coordinate or participate to specific projects related to process or tools improvements
Collaborate with the Quality Document network with associates from other functions
Certified health professional degree, examples: Pharmacist, Health Science degree, Bachelor of nursing degree
English fluent required
Minimum of 5 years experience required in:
GxP Quality system management
Quality Documentation or Medical writing
Electronic Data Management System (EDMS)
Pharmacovigilance and/or Medical activities
Knowledge and experience in:
International Pharmaceutical Regulations e.g. GVP, GCP, ICH
The role holder is details oriented, results-driven and can-do-attitude. He/she is required to cooperate transversally and committed to customer satisfaction.
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.
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.
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