パレクセルでの仕事
パレクセルは、臨床開発の上流から下流までのそれぞれの専門領域で、国内外の多くのお客様に高度なソリューションを提供するプロフェッショナル集団です。 パレクセルは、新しい薬や治療法を、それらを必要としている人々にいち早く届けることを目指し、日々の業務に取り組んでいます。
Local Qualified Person for Pharmacovigilance (QPPV) Freelancer - TALENT POOL
応募 求人ID R0000032290 ロケーション ポーランド共和国 仕事内容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