Job Description
ADAMAS Consulting is looking for PV Auditor on a freelance basis to cover audits across Europe. Both full and part time (0.6+ FTE) will be considered
Planning, preparation, conduct, reporting and follow up (including CAPA plans) of various types of Pharmacovigilance (PV) audits according to expected quality and timelines
Executing audits based on a comprehensive understanding of all regulatory requirements and Good Pharmacovigilance Practice (GVP)
Performing GVP quality assurance projects on behalf of client companies within the pharmaceutical/biotechnology industry.
Qualifications
Experience in conducting and leading internal and external Pharmacovigilance audits for a variety of stakeholders
Expert knowledge of national and international Pharmacovigilance legislation and guidelines
Proficient in managing projects and ensuring deliverables are provided timeously
Ability to identify issues and offer solutions in a pragmatic way
Bachelor’s Degree in Life Sciences preferred
Travel will be required for audits, additional to conducting remote audits
Additional Information
When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.
We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.
Quality: we hold ourselves to the standard patients deserve.
Integrity and trust: we do the right thing, especially when it is hard.
Drive and passion: we care about the outcome, because someone is waiting on it.
Agility and responsiveness: we move quickly, because patients cannot wait.
Belonging: everyone is welcome, and every voice counts.
Collaborative partnerships: we go further by going together.
We look forward to welcoming your application.
Pharmacovigilance Auditor - Freelance Position (1FTE or 0.6 FTE and above) • Bucharest, Bucharest, Romania
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