CHC PV Systems/DB Operations Lead - All Gender at Sanofi

Our Team

• This position is responsible for supporting Consumer Healthcare Pharmacovigilance team with lifecycle support of PV Database and it’s supporting systems
• As an Operations lead, responsibilities include managing PV Database hosting vendor, system functionality, user requirements and configuration specifications, system releases and service management tasks
• Provide system and administration support to business users within the Consumer Health PV organization including Consumer Healthcare PV Operations, PV Affiliates, PV Compliance, Safety Signal & Risk Management, Global Medical, Regulatory, Quality and other business functions
• This position is responsible for managing GxP validated systems including PV Database, Signal & Risk Management, Reporting system etc. and ensuring Agency Regulations are appropriately configured

Key results/accountabilities

• This position is Accountable for resolving and escalating incidents, managing user requests in collaboration with Digital teams and PV Database hosting Vendor
• Initiate discussions with business stakeholders to understand business requirements, document user requirements and ensure these are included on the Backlog List and addressed in collaboration with Vendor & Digital teams
• Communicate important messages relevant to all levels of stakeholders, including content and plan of systems releases, issues, etc.
• Plan for scheduled/ad-hoc releases by developing and execution of test scripts. Work in close collaboration with Vendor/Digital teams for the implementation of all releases in ensuring GxP validation requirements are met
• Ensure training materials are updated as releases move through the development and deployment process. Facilitate support and training sessions for system users
• Maintain systems access and assessing any impact to systems security due to the introduction of new system features. Conduct regular access management reviews to remain in compliance with corporate security policies
• Responsible for supporting Audit/Assessment/Inspection readiness and lead or participate in system internal audits and/or external inspections as needed
• Support oversight of vendor assigned staff for existing safety database during transition period, monitoring of KPIs, assist with incidents and escalations as needed as part of governance structure

Key working relationships

• This role will be the key contact point for peers in CHC PV organization for all topics related to the usage of shared systems and databases, ensuring that the CHC PV needs are met
• This position requires multiple interfaces with partners and customers within and outside of the Company
• It requires experience in managing complex issues in a global environment

About You

• The person can be based anywhere in the world where CHC has a Legal Entity.

Education

• Degree in Science or or relevant Academic qualification is desirable with 8 years experience in GxP systems preferably in PV databases

Required Knowledge And/or Experience

• Experience in PV Databases like ARGUS, ARISG, VAULT Safety etc.
• Experience in a systems operations support role within safety/pharmacovigilance as business analyst, configuration manager or business relationship manager
• Experience with leading safety systems
• Experience and understanding of the safety/pharmacovigilance process and regulations, ICH GCP and GxP regarding systems validation and documentation
• Knowledge of IT systems in the pharmaceutical industry with an emphasis on PV systems. Knowledge of validation processes
• Good knowledge of PL/SQL and MS Office
• Minimum 8 years of pharmaceutical industry experience with a focus on pharmacovigilance. Strong experience in IS and validation is required. Incumbent should have experience in Process Improvement practices

Language skills

• Fluent spoken and written English
• An Additional language is desirable

Key Dimensions

• Teamwork and Management skills
• Good interpersonal and negotiator skills
• Strong decision making skills

Play to Win Behaviours:

• Stretch
• Take action
• Act for patients & customers
• Think Sanofi first