Remote Freelance PV Auditor – Global Pharmacovigilance

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

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.