CHC PV Analytics & Reports Lead - All Gender at Sanofi

About The Job
Our Team

• This position is responsible for supporting Consumer Healthcare Pharmacovigilance team with lifecycle support of PV Reporting and Analytics systems
• As a PV Reporting & Analytics lead, your responsibilities include managing 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 PV Reporting & Analytics system and developing and maintenance of all Regulatory reports

Key results/accountabilities

• This position is Accountable for resolving and escalating incidents, managing user requests in collaboration with Digital teams and the hosting Vendor
• Initiate discussions with business stakeholders to understand reporting requirements, document user requirements and ensure these are included on the Backlog List and addressed in collaboration with Vendor & Digital teams
• Communicate effectively to all stakeholders, including content and plan of systems releases, issues, etc.
• Collect Business/Regulatory requirements, plan, design and develop reports and ensure the reports meets both Regulatory and GxP requirements
• 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
• Provide Audit support by providing ad-hoc reports and lead or participate in system internal audits and/or external inspections as needed
• Support oversight of vendor assigned staff for PV Reporting system and monitor KPIs and 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 Computer Science or Information Technology or relevant Academic qualification is desirable with at least 5 years' experience in GxP systems

Required Knowledge And/or Experience

• Experience in PV Databases like ARGUS/ARISG and Cognos Reports
• Experience in a PV reporting systems operations within safety/pharmacovigilance as business analyst, configuration manager or business relationship manager
• Experience with leading PV Reporting systems
• Experience and understanding of 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 10 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