PV Project Quality & Risk Lead

We are currently looking for an experienced PV Project Quality & Risk Lead to be based inCzechia (CZ) or in the UKwith flexible working hours.

Your time here

At Parexel, the PQRL assumes the lead (with support of LM or Mentor) of Quality oversight responsibility and partners with operational delivery teams focusing on first-time quality, robust risk and issue management and maintaining an inspection-ready state.  Provides quality expertise to support operations, leadership and clients enabling the safeguarding and maintenance of patient safety, data integrity and regulatory compliance.

The Quality Specialist focuses on PV activities, is assigned to projects and collaborates closely with the broader PQRM groups and other quality teams.

Knowledge and Experience:

• 2+ years’ experience in clinical research and/or experience in pharmacovigilance (pre- and post-authorization)
• Quality and Risk Management experience is desired
• Knowledge of ICH-GxP principles and clinical trial or non-clinical trial regulations as applicable
• Knowledge of PV Directives, FDA CFR and EMA GVP as applicable
• English proficiency (written and oral)

Skills:

• Good interpersonal, verbal and written communication skills including effective listening, facilitating group discussions, influencing without authority and providing appropriate feedback
• Ability to plan, organize, prioritize and manage workload with LM guidance, keeping the patient and client at the focus 
• Quality oriented with an attention to detail, taking initiative, ownership and accountability for deliverables
• Developing the ability to manage the complexity of a matrix environment while valuing the importance of teamwork
• Ability to travel 10% -15%

Education:

• Bachelor’s Degree or other relevant experience required. Life-science or other health-related discipline preferred

A little about us:Parexel is proud to be a leading Clinical Research Organization with colleagues across the globe. As a member of our team, you’ll get to know your coworkers on a personal level. Have a question? A clinical research leader, project team member, technology “super user” or collaborator are a phone call away.

Our clinical research teams meet regularly to have discussions in an open environment, allowing our team members to share their expertise and promote learning within the team. Management supports and encourages career growth through consistent performance discussions and evaluations. Whether your interest is to progress into a more senior level role, into line management, Quality, Project Leadership or a variety of other positions, Parexel prides itself on career opportunities for our employees