Main responsibilities:

Manage the PV Configuration Standards, Distribution Rules, Study Configurations in LSMV, LSR & EV triage module

Perform User Accept Testing for Configuration Changes on behalf of the PV Systems Business Team

Work with Business Users to understand the Configuration changes and document them

Participate in updating training materials as releases move through the development and deployment process. Facilitate support and training sessions for system users

Support Safety Team during Audits & Inspections for providing Safety Data and Ad-hoc reports on urgency basis

Analyze the impact of changes to the system not just limited to Upgrades, Config Changes, Introduction of new features, and any other potential changes to the PV System

Implement relevant action items to mitigate any potential issues arising based on the Impact Analysis

Responsible for PV System Configurations of PV database-

Clinical & Post marketed Studies

​Company Products

Business user Roles & Data Privacy

Code Lists, Libraries, MedDRA, WHO

Distribution Rules

Accounts & HA Destinations

E2B Profiles

SDEA profiles & gateway

Manage E2B gateway with Health authorities & Business Partners

Implement Data Migration & Ingestion requests

Actively participate and contribute to the growing needs of Drug Safety PV Regulations

Support digital vendor teams in Configuration Changes needs, Testing & Deployments

Work with Business Users to understand the Configuration change needs and document them

Work in an Agile environment

About you

Experience:

Experience in PV Databases like ARGUS, Aris-G, VAULT Safety, LSMV etc.

Experience in a systems operations support role within safety/pharmacovigilance as configuration analyst, configuration manager

Hands-on in Case Processing to support the Business User for troubleshooting and problem solving

Experience in configuration of Products, INNs, Salts and their variations, MedDRA Events

Hands-on experience in dealing with Local Affiliates and understanding their Regulatory needs

Experience and understanding of the safety/pharmacovigilance process and regulations, ICH GVP 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 SQL, PL/SQL and MS Office

Minimum 5 years of pharmaceutical industry experience with a focus on pharmacovigilance

Strong experience in Computer System Validation is required

Incumbent should have hands-on in Process Improvement practices

Soft skills:

Stakeholder management, Strong negotiation and communication skills, and ability to operate effectively in a global environment and across-line functions.

Attention to details, Analytic, pro-active and effective problem-solving skills. Excellent organizational and project management abilities.

Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams.

Excellent team-work and interpersonal skills

Ability to work in cross-functional teams

Excellent oral and written communication skills

Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams.

Technical skills:

Regulatory Standards, Good Pharmacovigilance Practices (GxP), PV Configurations, Safety risk management, Safety Reporting Requirements.

Database Management: Familiarity with safety databases and systems (e.g., Aris-G / LSMV, Argus Safety, VigiBase, or similar systems) used for collecting, analyzing, and reporting adverse event data.

Software Testing/Validation: Knowledge of user acceptance testing (UAT) for pharmacovigilance software and familiarity with data migration processes during system upgrades

Good depth understanding of Quality Risk Management and Quality systems

Education:

Bachelor’s degree in pharmacy / Life Sciences / Engineering or equivalent Academic qualification is desirable with 5  years’ Technical Experience in GxP systems preferably in PV databases

Languages: Fluent in English (verbal and writt

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