Title Pharmacovigilance Data Analysis

Recordati
Puteaux, France
2 months ago

Role details

Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Experience level
Experienced
Experience required
2 years minimum
Working hours
Regular working hours
Languages
English
Job source

Tech stack

Data Analysis Databases Data Streaming Data Management

Job description

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., 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

Requirements

  • Scientific degree (Life Sciences or equivalent), * 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)

About the company

At Recordati, we are united by a clear purpose: unlocking the full potential of life. With a century of history behind us, we are building the next chapter of our journey, continuing to grow while keeping patients at the centre of all we do.

What drives us is a shared belief that health, and the opportunity to live life to the full, should be within reach for everyone. This brings energy to our work, shaping how we support each other and show up every day. Our values - Better Together, Never Settle and Always Deliver - reflect this mindset, helping us to keep improving and make a meaningful difference.

Above all, these values bring to life our promise to everyone at Recordati, you can unlock your full potential. We know that people thrive when they can be themselves, are trusted and supported, and are given the opportunity to grow and make a meaningful contribution., At Recordati we believe in people! Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential.

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