Panacea: EU QPPV - Role based in EU (ideally located in Amsterdam)
Competitive salary plus executive benefits
Panacea is a Pharmacovigilance & Regulatory Affairs partner providing services to an expanding client base across Europe and US. We pride ourselves on our excellent relationships with our customers, developed through providing a truly tailored, fully compliant service. Due to continued growth, we intend to further expand our infrastructure to create an expert, senior presence in Amsterdam. We are looking for an EU QPPV to work primarily from home, with travel as necessary to clients, to meet with UK-based colleagues and to the Panacea HQ on the Isle of Man.
You will fulfill the role of EU QPPV in accordance with the applicable EU legislation. As QPPV you will be accountable for the performance and maintenance of the Pharmacovigilance (PV) System and responsible for compliance under GVP, national and EU legislation.
In this vital role, the QPPV will work closely with the Director of QPPV Services and the Operations Director as well as our teams of Safety Scientists, ensuring the performance and maintenance of the Pharmacovigilance system is fully compliant. This will, naturally, involve oversight of the various processes involved in pharmacovigilance including ICSR collection and reporting, PSMF maintenance, production of PSURs, RMPs and signal detection reports as well monitoring compliance.
The successful candidate must meet the requirements to be appointed as QPPV in the EU and have suitable, demonstrable experience in pharmacovigilance and the pharmaceutical industry. It is expected that you will be able to evidence high standards in compliance management in previous roles. The position requires expert knowledge of pharmaceutical regulations, standards, current industry practices and experience with interpretation and application.
The job requires strong leadership, pragmatism and organisational skills with the flexibility to succeed in a fast-growing environment. You will also need excellent interpersonal, communication, presentation and facilitation skills, and the ability to identify risks, to make decisions independently, and to escalate issues when necessary.
To apply, please send your CV and covering letter to email@example.com quoting reference QPPV0820 and mark your application for the attention of the Chairman. For more information on Panacea visit www.panacea.im
Closing Date: 11th September 2020
Note: AGENCY APPLICATIONS WILL NOT BE CONSIDERED