Local Pharmacovigilance Head (LSO)
Excelya
Job description
About the role
Join Excelya, where Audacity, Care, and Energy define who we are and how we work. This role offers an exciting opportunity to contribute to a dynamic, ambitious team and to drive innovation in the clinical research space while enjoying a stimulating professional environment that encourages personal and intellectual growth.
Key responsibilities
- Lead and maintain the local Pharmacovigilance function, ensuring full compliance with regulatory requirements and company standards.
- Serve as the primary PV contact for Health Authorities, leading 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, covering compliance monitoring, investigations, CAPAs, training and inspection readiness.
- Partner with cross‑functional teams and external vendors to implement robust PV processes and maintain safety governance.
- Drive continuous improvement of local PV operations through proactive risk identification, regulatory intelligence and stakeholder engagement.
Required profile
- Degree in Life Sciences, Pharmacy, Medicine or a related field.
- Based in Slovakia with fluency in Slovak (native preferred) and English (spoken and written).
- Minimum of 5 years experience in pharmacovigilance; prior head‑level experience is an asset.
- Strong knowledge of local and global PV regulations.
- Experience with audits, inspections and vendor management.
- Excellent organizational and leadership abilities.
- Strong communication and collaboration skills across cross‑functional teams.
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