Support quality oversight across countries on the country PV deliverables
Promote harmonization of quality standards at region and country level
Liaison between PV Quality team and Regional Safety Leads
Highlight PV Quality risks, issues and mitigation plan to Regional Quality Heads
Support CSLs to create and maintain robust PV components of the local quality system
Potential Specific Domains
Requires in-depth knowledge and experience in own discipline and the environment
Develop strong network with key stakeholders
Recognized as an expert in own area within the organization
Organized and detail oriented, efficient time management
Analytic, pro-active and effective problem solving skills.
Key Contributions & Activities
Serves as Regional PV Quality Liaison
Being the primary point of contact with the Regional PV Head for quality PV aspects
In case of specific SDEAs partnership, provide deep knowledge of the organization and points for attentions
Provide quality advice to PV Region team in case of questions related to PV system from HA to understand the request and validate the response strategy
Participate actively for PV inspections and audits
Country Quality Oversight :
Country quality metrics : Work in close collaboration with the Region Transverse Coordination office in providing inputs on quality items to development of tools to be used by all regions (i.
e. Affiliate Governance tool) and in using common tools / templates to allow a consistent oversight of the PV activities / data across regionsCreate Quarterly Quality dashboards to deliver to Region Leads / countries providing oversight on country quality PV milestones / KPIs
Quality Risk management : Contribute to the development of a risk based profile grid for country quality PV system to assess situation of the International networkCollect PV deviations across regions through diverse repository and tools,Analyze PV trends across regions or mature / emerging markets through QR profileDevelop continuous improvement plans across countries for recurrent PV deviations / findingsPerform prioritization of CAPA based on risk based approachProvide recommendations to country PV systems in accordance with global processes in collaboration with Region Safety leads and QTC managersProvide guidance to CSL to track and assess impact assessment of deviations at local levelCollaborate with Country Quality Head and CSL on RQN impacting country PV activities, ensuring timely resolution of CAPAs
Audits / Inspections : Lead collaboration with CSL in the preparation of GQA country office audits, definition of root-
cause analysis and CAPA follow-up
Contribute to the application of principles of good PV practice and ethical standards at country level, ensuring PV components of local quality system are in place and monitored Provide support for the development and maintenance of the LPSMFSupport compliance of quality documents with local PV regulations and global sanofi proceduresEstablish interfaces and align activities with MCCQ teams to ensure consistent implementation of local quality system strategy
Country PV trainings : Contribute to the country PV training strategy based on risk based approach and support development of educational materials
Scope of Responsibility :
Responsibilities cover PV activities across all BUs. Works in very close collaboration with the Region Safety Leads, Quality GPV managers, QPPV, and Country Quality Heads, to allow robustness of the Sanofi Country PV system.
Management Responsibilities :
No direct line management responsibilities
Latitude of action
The role holder is required to work autonomously and to take decisions in line with Sanofi Global Quality Policy, Standards and Processes.
It is a key role in ensuring coherent application of Sanofi Quality requirements across the MCCQ network supported.
The role holder works directly with GBU Medical, Pharmacovigilance, Regulatory, and Clinical and across the local sanofi commercial offices (all sanofi legal entities) as well as with colleagues from other Quality operational units as required.
Education & Experience :
Pharm D or Master Degree in Human Health Sciences
Minimum 5 years’ experience in managing Pharmacovigilance activities in close collaboration with key departments (Medical Affairs, Regulatory, Clinical, Quality Assurance, etc.)
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