PHARMACOVIGILANCE AUDITOR - FREELANCE POSITION (1FTE OR 0.6 FTE AND ABOVE)
Ergomed
Full-timemid
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Job description
<p>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 </p><ul><li><p>Planning, preparation, conduct, reporting and follow up (including CAPA plans) of various types of Pharmacovigilance (PV) audits according to expected quality and timelines </p></li><li><p>Executing audits based on a comprehensive understanding of all regulatory requirements and Good Pharmacovigilance Practice (GVP) </p></li></ul><ul><li><p>Performing GVP quality assurance projects on behalf of client companies within the pharmaceutical/biotechnology industry.  </p></li></ul>
<ul><li><p>Experience in conducting and leading internal and external Pharmacovigilance audits for a variety of stakeholders  </p></li></ul><ul><li><p>Expert knowledge of national and international Pharmacovigilance legislation and guidelines  </p></li><li><p>Proficient in managing projects and ensuring deliverables are provided timeously  </p></li><li><p>Ability to identify issues and offer solutions in a pragmatic way  </p></li><li><p>Bachelor’s Degree in Life Sciences preferred  </p></li><li><p>Up to 40% travel and ability to conduct remote audits </p></li></ul>
<p>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.  </p><p>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. </p><ul><li><p>Quality: we hold ourselves to the standard patients deserve. </p></li></ul><ul><li><p>Integrity and trust: we do the right thing, especially when it is hard. </p></li></ul><ul><li><p>Drive and passion: we care about the outcome, because someone is waiting on it. </p></li></ul><ul><li><p>Agility and responsiveness: we move quickly, because patients cannot wait. </p></li></ul><ul><li><p>Belonging: everyone is welcome, and every voice counts. </p></li></ul><ul><li><p>Collaborative partnerships: we go further by going together. </p></li></ul><p>We look forward to welcoming your application. </p>
Skills
PharmacovigilanceGVPQuality AssuranceCAPARegulatory Requirements