Local Qualified Person for Pharmacovigilance (QPPV) Freelancer - TALENT POOL

Parexel; Italia; Remoto; EUR 60.000 - 100.000; Tempo pieno

Descrizione del lavoro

Parexel is seeking Local Qualified Persons for Pharmacovigilance (QPPV) contractors, responsible for overseeing compliance with local PV legislation and global requirements. Candidates should have at least 7 years of experience in managing PV systems, ensuring patient safety and regulatory adherence. This role can be performed remotely within select EMEA locations and Australia.

Competenze

• Minimum of 7 years' experience in pharmacovigilance.
• Documented experience in all aspects of PV.
• Extensive knowledge of global pharmacovigilance regulations.

Mansioni

• Fulfill responsibilities as the Local QPPV.
• Manage pharmacovigilance safety systems.
• Ensure compliance with GVP and GCP guidelines.

Conoscenze

Expert knowledge of local PV legislation

Managing or implementing PV systems

Pharmacovigilance safety risk management

Descrizione del lavoro

When our values align, there's no limit to what we can achieve.

Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values: Patients First, Quality, Respect, Empowerment & Accountability.

The Pharmacovigilance team is looking to build a network of Local Qualified Person for Pharmacovigilance (QPPV) FREELANCERS for future projects.

The role can be based remotely in select EMEA locations and Australia.

Requirements

• Expert knowledge of local PV legislation in the territory(ies) where assigned as the Local QPPV.
• Minimum of at least 7 years' demonstrated experience in managing or implementing PV systems, including quality assurance experience.
• Documented experience in all aspects of PV to fulfill the responsibilities of the Local QPPV.
• Extensive knowledge of global pharmacovigilance regulations and GVP and GCP guidelines.
• Experience in pharmacovigilance safety risk management, including clinical trials, post-market pharmacovigilance, safety case processing, safety reporting, and safety systems.