About the Job
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 and ambitious team. 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
- Lead and maintain the local Pharmacovigilance function, ensuring full compliance with applicable regulatory requirements and company standards.
- Serve as the primary PV contact for Health Authorities and lead PV inspections, audits, and regulatory interactions.
- Oversee local safety monitoring activities, including case management, signal detection, risk management, and reporting obligations.
- Ensure the effectiveness of local PV quality systems, including compliance monitoring, investigations, CAPAs, training, and inspection readiness.
- Partner with cross-functional teams and external vendors to implement robust PV processes and ensure appropriate safety governance.
- Drive continuous improvement of local PV operations through proactive risk identification, regulatory intelligence, and stakeholder engagement.
Requirements
-Degree in Life Sciences, Pharmacy, Medicine, or related field.
- Based in SK with Fluency in Slovak language (ideally native speaker) and fluency in English (spoken and written) is required.
- At least 5 years of experience in pharmacovigilance, prior experience in a similar position will ne considered an asset
- Strong knowledge of local and global PV regulations.
- Experience with audits, inspections, and vendor management.
- Excellent organizational and leadership skills.
- Strong communication and collaboration skills across cross-functional 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.
Skills Required
- Degree in Life Sciences, Pharmacy, Medicine, or a related field
- Based in Slovakia
- Fluency in Slovak and English, spoken and written
- At least 5 years of pharmacovigilance experience
- Strong knowledge of local and global pharmacovigilance regulations
- Experience with audits and inspections
- Experience with vendor management
- Excellent organizational and leadership skills
- Strong communication and cross-functional collaboration skills
- Previous experience in a similar position
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.
