PV Auditor - Freelance Position

Job summary

Plan, prepare, conduct, report, and follow up on pharmacovigilance audits, including CAPA plans, in line with quality expectations and timelines. Perform GVP quality assurance projects for pharmaceutical and biotechnology clients.

Job details

Company Description Medicine moves forward here. So will you. ADAMAS Consulting helps the world's pharmaceutical and biotechnology companies uphold the highest standards of quality, compliance and patient safety. Since 2007 we have partnered with organizations across GCP, GVP, GMP, GLP and Computer Systems Compliance, and we are trusted by many of the most respected names in life sciences. We think of our work as more than auditing. At its best it is intelligence: helping clients see the compliance risks that matter most and prevent the problems that could put patients at risk. That takes sharp, independent thinking and deep expertise, which is exactly what our people bring. Here your knowledge is valued and shared, not kept in silos. We have built a supportive, collaborative environment where professional growth is encouraged and where you can make a real impact across the industry, working alongside some of the most respected companies in the field. Job Description ADAMAS Consulting is looking for PV Auditor on a freelance basis to cover audits across USA and Canada. 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 Up to 40% travel and ability to conduct 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.

What you’ll do

Plan, prepare, conduct, report, and follow up on pharmacovigilance audits, including CAPA plans, in line with quality expectations and timelines. Perform GVP quality assurance projects for pharmaceutical and biotechnology clients.

Requirements

Candidates should have experience leading internal and external pharmacovigilance audits for varied stakeholders and expert knowledge of national and international pharmacovigilance regulations and guidelines. They should be proficient in project management, deliverables, and pragmatic issue resolution; a bachelor's degree in life sciences is preferred, along with availability for up to 40% travel and remote audits.

Listed skills

• Problem solving · Preferred
• Quality assurance · Preferred
• Regulatory Compliance · Preferred
• Project management · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Pharmacovigilance Auditing
• Good Pharmacovigilance Practice
• Regulatory Compliance
• Audit Planning
• Audit Preparation
• Audit Conduct
• Audit Reporting
• CAPA Management
• Quality Assurance
• Project Management
• Regulatory Legislation and Guidelines
• Issue Identification
• Problem Solving
• Remote Auditing

Job areas

• Healthcare
• Consulting
• Science & Research
• Security & Safety