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Qualified Person Responsible for Pharmacovigilance (QPPV) in the EU and UK (homebased)
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Regulatory Affairs
Communication
Key Responsibilities:
- Define and oversee Toxicology and Non-Clinical Pharmacology strategies for assigned projects.
- Account for Toxicology and Non-Clinical Pharmacology modules in regulatory documents.
- Manage preclinical safety studies in CROs and ensure translational aspects are integrated.
Qualifications:
- PhD, DVM, or equivalent with minimum 5 years of experience as a project toxicologist.
- Experience with biologics and small molecules required; gene therapy or combination drugs a plus.
- Board certification such as DABT/ERT preferred.
Skills & Competencies:
- Extensive regulatory toxicology experience and solid understanding of drug development process.
- Excellent communication and presentation skills, with fluency in English.
- Strong problem-solving ability and analytical mindset.
Why Join Us?:
- Empower every person to make a difference for rare disease in a global company with over 1,900 employees.
- Be part of a culture that values Care, Ambition, Urgency, Ownership, and Partnership.
- Enjoy a competitive total rewards package in a team dedicated to innovation.
Sobi
A biopharmaceutical company dedicated to developing innovative therapies for rare diseases. With over 1,900 employees in more than 30 countries, Sobi fosters a culture of inclusion and empowerment.