PV Auditor - Freelance Position

ADAMAS Consulting; Mississauga; Teletrabalho; CAD 70 000 - 110 000; Tempo integral

Resumo da oferta

ADAMAS Consulting is seeking a Pharmacovigilance Auditor for freelance work across USA and Canada, including both full and part-time arrangements (0.6+ FTE). The role covers audits, CAPA planning, and reporting in line with GVP.

Ideal candidates will have PV audit leadership experience, strong regulatory knowledge, and willingness to travel up to 40% with remote auditing capability across North America.

Qualificações

• Experience in conducting and leading internal and external Pharmacovigilance audits.
• Expert knowledge of national and international Pharmacovigilance legislation and guidelines.
• Up to 40% travel and ability to conduct remote audits.

Responsabilidades

• Planning, preparation, conduct, reporting and follow up of PV audits including CAPA plans.
• Executing audits based on GVP requirements and regulatory standards.
• Performing PV quality assurance projects for client companies in pharma/biotech.

Conhecimentos

PV audits experience

Regulatory knowledge

Formação académica

Bachelor's Degree in Life Sciences

Descrição da oferta de emprego

Company Description

Medicine moves forward here. So will you.

Company Description

Medicine moves forward here. So will you.

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

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.

• 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.