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.
This role is an exciting opportunity to contribute to a dynamic, ambitious team in Pharmacovigilance. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.
Main Responsibilities:
- Supervise pharmacovigilance case management outsourced to assigned platform(s)
- Respond to case-related emails and inquiries from external service providers
- Monitor case processing timelines and investigate any delays in reporting or transmission
- Participate in weekly quality control of data entry, MedDRA coding, and narrative writing
- Support the review and validation of clinical study case narratives for inclusion in study reports
- Contribute to the reconciliation of PV cases with business partners per Safety Data Exchange Agreements (SDEAs)
- Oversee reconciliation of cases with clinical databases managed by outsourced providers
- Collaborate closely with cross-functional and global teams to ensure compliance and data integrity
Requirements
At Excelya, taking audacious steps is encouraged, so we're looking for individuals who are ready to grow with us and share our values.
- Experience: Proven ability to thrive in collaborative, fast-moving environment
- Skills: Solid understanding of global PV regulations and quality systems, experience in managing CAPAs, deviations, and regulatory compliance indicators, familiar with the preparation and conduct of audits and inspections (internal and external).
- Education: Doctor of Pharmacy (PharmD) degree required.
- Languages: Fluent in written and spoken English and French; strong communication skills with global teams.
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
- Doctor of Pharmacy (PharmD) degree
- Solid understanding of global PV regulations and quality systems
- Experience in managing CAPAs and regulatory compliance indicators
- Familiar with the preparation and conduct of audits and inspections
- Fluent in written and spoken English and French
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.
