Pharmacovigilance Project Manager

Posted 4 Days Ago
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Boulogne-Billancourt, Hauts-de-Seine, Île-de-France, FRA
In-Office
Entry level
Biotech • Pharmaceutical
The Role
Manage pharmacovigilance case processing from receipt through reporting, including adverse event assessment, quality review, medical consistency checks, signal detection, literature surveillance, regulatory intelligence, periodic safety reporting, and inspection-ready documentation. Collaborate with global safety, medical, clinical, and external stakeholders while supporting PV process improvements, escalation, communication, and regulatory compliance throughout the product lifecycle.
Summary Generated by Built In

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

In this role, you will combine operational PV expertise with project coordination responsibilities to ensure patient safety and regulatory compliance throughout the product lifecycle.

Main Responsibilities:

  • Manage and oversee pharmacovigilance case processing activities from receipt to reporting.
  • Collect, assess, document, and follow up on adverse event reports from multiple sources.
  • Perform quality review and medical consistency checks of safety cases prior to submission.
  • Support local signal detection activities and contribute to safety monitoring initiatives.
  • Participate in literature surveillance and regulatory intelligence activities.
  • Contribute to periodic safety reports and monthly PV activity reporting.
  • Collaborate with Global Safety, Medical Information, Clinical Teams, and external partners.
  • Maintain complete and inspection-ready PV documentation, tracking, and archiving.
  • Support the review and continuous improvement of local PV procedures and processes.
  • Act as a key PV contact, ensuring clear communication, escalation, and stakeholder management.

Requirements

Experience: Pharmacovigilance experience within a pharmaceutical company, CRO, or regulatory environment, Strong hands-on experience in PV case processing, signal detection and safety data management

Education: Degree in Pharmacovigilance, Life Sciences, Clinical Development, Pharmacy, or related field.

Technical Skills: Experience with PV databases, ideally Argus Safety., Solid knowledge of MedDRA coding and terminology, Good command of Microsoft Office tools (Excel, Word, PowerPoint, Outlook).

Soft Skills: Proactive, autonomous, and highly organized.

Languages: Fluent in French & English, both written and spoken.


Benefits

Why Join Us?

At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.

Here's what makes us unique—

We are a young, ambitious health company representing 900 Excelyates, driven to become Europe's leading mid-size CRO with the best employee experience. Our one-stop provider service model—offering full-service, functional service provider, and consulting—enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey.

Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.

Skills Required

  • Pharmacovigilance experience within a pharmaceutical company, CRO, or regulatory environment
  • Strong hands-on experience in pharmacovigilance case processing, signal detection, and safety data management
  • Degree in Pharmacovigilance, Life Sciences, Clinical Development, Pharmacy, or a related field
  • Experience with pharmacovigilance databases, ideally Argus Safety
  • Knowledge of MedDRA coding and terminology
  • Good command of Microsoft Office tools, including Excel, Word, PowerPoint, and Outlook
  • Fluency in written and spoken French and English
  • Proactive, autonomous, and highly organized
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The Company
HQ: Boulogne-Billancourt
697 Employees
Year Founded: 2014

What We Do

Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of Full-service CRO, FSP, and Resourcing solutions guided by compassion, care, and excellence. Founded in 2014 and headquartered in Paris, France, and operating in 28 countries across Europe, USA and India, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas, with speciality focus on Oncology & Hematology, Rare Disease & Pediatrics, Infectious Disease, Inflammation & Immunotherapy, Pain Treatment & CNS, and Late Phase & RWE.

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