Offer summary

Qualifications:

At least 7 years of experience in pharmacovigilance management or implementation., Expert knowledge of local PV legislation in the assigned territory., Extensive understanding of global pharmacovigilance regulations, GVP, and GCP guidelines., Proven experience in safety risk management, safety reporting, and PV systems..

Key responsibilities:

Manage and oversee pharmacovigilance activities as the Local QPPV.

Ensure compliance with local and global PV regulations and guidelines.

Implement and maintain PV systems and processes.

Support safety risk management and safety reporting for clinical trials and post-market activities.

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.

Job description

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

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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 are 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 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 in order 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

Required profile