At PRA Health Sciences, providing innovative solutions for our clients is what we do! From full service clinical development to the pioneering Embedded SolutionsTM model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace.
At PRA, borders do not create boundaries. PRA’s success is dependent upon our ability to attract and retain a talented team of diverse professionals. Our growing workforce is comprised of over 15,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages – yet operate in unison as one worldwide PRA community.
For more information please see our website: www.prahs.com
A key attribute for PRA and our clients, is the drive to produce great results and to advance treatment options available to patients worldwide. We always have a desire to keep seeking new and better ways to operate, to achieve these results and this is where our Strategic Solutions Division comes in!
Leveraging the advantages of working for a top-5 CRO, whilst simultaneously working fully-dedicated to a leading pharma company, will guarantee that the results you help accomplish in drug development are matched by your own career achievements.
In this new and exciting Drug Safety position, you will be fully responsible for overseeing, managing and carrying out PV activities in China! This unique role will also lead the regulatory intelligence and share and provide updates to stakeholders regionally and locally.
There will be high levels of interaction with global PV Teams and you will provide China-specific knowledge, expertise and representation on PV-related projects, teams, and taskforces.
Additional skills that are key to the success of this position:
- Strong cross functional communication skills that allow for seamless execution of PV related activities whilst considering the impact of other contributors and stakeholders.
- Support for the PV Management Team in addressing consistency in collection, processing and evaluation of safety data, development of global SOPs and policies to ensure compliance with regional regulatory requirements and to drive improvements in client global processes.
- Support for the PV Management with overseeing coordination of activities, timelines, and cross functional coordination for documents coming from PV, including regulatory submissions and responses, aggregate reports and other related tasks for China.
- Perform regular regulatory intelligence activities within China. Where regulatory requirements change, you will assess implications on the current reporting processes and support implementation of changes (where required).
- Support PV-related audits and regulatory inspections in China and the region with regard to logistics, conduct, responses to subsequent reports and implementation and tracking of CAPAs.
In addition to the above experience, we are looking for candidates who are excited by the dynamic China market and who want to work within a passionate and motivated team where timely and proactive communication is critical to success.
We require at least 4 years pharmaceutical or contract research organization experience within drug safety for this position and you should hold an industry relevant degree. Excellent communication skills and fluency in English and Mandarin are essential attributes for this opportunity.
Together with a competitive salary, we offer a comprehensive range of benefits and an excellent working environment.
PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace