Local PV Head (LSO)

Excelya; Österreich; Vor Ort; EUR 70.000 - 110.000; Vollzeit

Zusammenfassung

Excelya is seeking a Pharmacovigilance Lead to manage the local PV function and ensure regulatory compliance across activities. You will serve as the main PV contact for Health Authorities, lead inspections and audits, and guide safety monitoring and reporting with cross-functional teams and external vendors.

The role emphasizes building robust PV quality systems, CAPA investigations, and proactive risk management, in a dynamic EU setting that values growth and collaboration.

Qualifikationen

• Degree in Life Sciences, Pharmacy, Medicine, or related field.
• EU-based with German and English fluency (spoken and written).
• 5+ years of experience in pharmacovigilance; asset for similar roles.
• Strong knowledge of local and global PV regulations.
• Experience with audits, inspections, and vendor management.
• Excellent organizational and leadership skills.
• Strong communication and collaboration across cross-functional teams.

Aufgaben

• 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.

Kenntnisse

Leadership

Organizational skills

Communication

Cross-functional collaboration

Regulatory knowledge

Ausbildung

Degree in Life Sciences, Pharmacy, Medicine, or related field

Jobbeschreibung

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.

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 EU with Fluency in German language (spoken and written) and fluency in English (spoken and written) is required
• At least 5 years of experience in pharmacovigilance, prior experience in a similar position will be 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.