Pharmacovigilance Data Analysis
Puteaux, FR
Job Purpose
The purpose of this role is to support the Pharmacovigilance department in the management of cases in the safety database (Argus), ensuring efficient handling of case-related data and workflows.
The PV Case Processing Associate is part of the Case Processing team and plays a key role in maintaining data quality, supporting operational activities (including mailbox monitoring and reporting), and acting as a bridge between Pharmacovigilance, IT, service provider and external partners.
Key Responsibilities
Database & Argus Expertise
- Generate listings and reports from the safety database
- Support the daily use of Argus Safety, including user support for product and study configuration
Operational Support & Mailbox Monitoring
- Monitor PV mailboxes
- Support ICSR monitoring and coordination with internal stakeholders and vendors
Cross-Functional Collaboration & IT Interface
- Act as a key point of contact between PV and IT teams for system and data flow topics
- Work closely with PV teams, affiliates, service provider and external partners to ensure smooth operations
Quality & Inspection / Audit readiness
- Assist with the preparation of the audit/inspection and participate in the audit/inspection when appropriate
- Support the reconciliation process
- Create or update the quality documents to reflect the actual processes in place.
- Participate in the periodic QC and any other QC-related activities when appropriate
Process Improvement & Compliance
- Contribute to continuous improvement of PV systems and processes
- Ensure activities are performed in compliance with internal procedures and regulatory requirements
Required Education
- Scientific degree (Life Sciences or equivalent)
Required Skills and Experience
- 2-years of experience in Pharmacovigilance
- Strong hands-on experience with Argus Safety
- Good understanding of ICSR workflows and PV operations
- Experience in data management, reporting, or database administration.
Technical Competencies
- Proficiency in Argus Safety
- Ability to extract, analyze, and interpret database listings
- Good knowledge of MS Office tools
Required Behaviours and Competencies
- Strong team spirit and collaborative mindset
- Ability to work cross-functionally in an international environment
- Strong organizational skills and ability to manage multiple priorities
- Rigorous, proactive, solution-oriented, and adaptable
Required Languages
- English (written and spoken and reading comprehesion - international environment)
Travel required in %