Freelancer Country Safety Head (German Speaker)

About the role

Excelya is seeking a part‑time Freelancer Country Safety Head who is fluent in German and English. You will lead the local pharmacovigilance (PV) function, ensuring compliance with regulatory requirements and supporting the company’s global safety strategy.

Key responsibilities

• Lead and maintain the local PV function, guaranteeing full regulatory compliance.
• Act as the primary PV contact for health authorities and manage inspections, audits, and regulatory interactions.
• Oversee 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.
• Collaborate with cross‑functional teams and external vendors to implement robust PV processes and governance.
• Drive continuous improvement through proactive risk identification, regulatory intelligence, and stakeholder engagement.

Required profile

• Degree in Life Sciences, Pharmacy, Medicine or a related field.
• Based in the EU with fluency in German (spoken and written) and English.
• Minimum 5 years of experience in pharmacovigilance, preferably in a leadership or country‑head role.
• Strong knowledge of local and global PV regulations and experience with audits, inspections, and vendor management.
• Excellent organizational, leadership, communication and collaboration skills.

Required skills

• Pharmacovigilance
• Case management
• Signal detection
• Risk management
• Regulatory compliance
• Audit management
• Vendor management

What we offer

• Opportunity to work with a fast‑growing European CRO.
• Flexible freelance arrangement.
• Engagement in high‑impact projects that shape patient safety.