PV Auditor - Freelance Position

Ergomed; Bogotá ciudad; Presencial; COP 308.528.000 - 431.939.000; Jornada completa

Descripción de la vacante

Ergomed is looking for a PV Auditor on a freelance basis to cover audits across the USA and Canada. Both full and part time (0.6+ FTE) will be considered. Up to 40% travel and the ability to conduct remote audits are required.

Planning, preparation, conduct, reporting and follow up (including CAPA plans) of various PV audits according to GVP standards. Proficient in managing projects and ensuring timely deliverables.

Formación

• 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.

Responsabilidades

• Planning, preparation, conduct, reporting and follow up PV audits according to expected quality and timelines.
• Executing audits based on GVP requirements and regulatory standards.
• Performing PV quality assurance projects for client companies in pharma/biotech.

Conocimientos

PV audits

Project management

Regulatory knowledge

Remote auditing

Educación

Bachelor’s degree Life Sciences

Descripción del empleo

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.