AD Pharmacovigilance Systems, EMEA

at  Thermo Fisher Scientific

JOB DESCRIPTION

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

IN THIS ROLE YOU WILL OVERSEE A TEAM OF SAFETY DATABASE ANALYST AND WORK DIRECTLY WITH A CUSTOMER TO DELIVER RELIANT, COMPLIANT, AND EFFICIENT SAFETY DATABASE THROUGHOUT ALL PHASES OF THE LIFECYCLE.A DAY IN THE LIFE:

• Management of LSMV across the entire lifecycle, including Safety Database migration
• Previous experience in PV System Validation
• Experience with the application of reporting tools
• E2B Gateway set-up and testing
• Experience in PV Tech Audits and Inspections
• Line Management of PV Tech professionals

BACHELOR’S DEGREE OR EQUIVALENT AND RELEVANT FORMAL ACADEMIC/VOCATIONAL QUALIFICATION TO INCLUDE 5+ YEARS OF SAFETY SYSTEMS EXPERIENCEIN SOME CASES AN EQUIVALENCY, CONSISTING OF A COMBINATION OF APPROPRIATE EDUCATION, TRAINING AND/OR DIRECTLY RELATED EXPERIENCE, WILL BE CONSIDERED SUFFICIENT FOR AN INDIVIDUAL TO MEET THE REQUIREMENTS OF THE ROLE.KNOWLEDGE, SKILLS, ABILITIES

• Strong influential skills with the ability to meet the objectives of cross-functional teams
• Broad understanding of PV systems, testing and validation processes along with the working knowledge of global regulatory requirements and the importance of procedural/process compliance
• Proficient in delivering successful PV Technology initiatives on time and budget.
• Proficient in Microsoft Office products and Safety Databases and other PV software is desirable
• Strong critical thinking, problem solving and decision-making skills
  Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.