Sr Safety Coordinator for i3 Drug Safety in Ann Arbor, MI or

UnitedHealth Group is an innovative leader in the health and well-being industry, serving more than 55 million Americans. Through our family of companies, we contribute outstanding clinical insight with consumer-friendly services and advanced technology to help people achieve optimal health.





i3 Drug Safety:

i3 Drug Safety, a UnitedHealth Group company, provides scientifically based solutions for the pharmaceutical and medical industries. Our services include epidemiology and safety research, economic and outcomes research. Our Epidemiology division is located in Newton, MA and has a world-renowned reputation for conducting research and providing consulting about the safety and effectiveness of medications and devices. We offer expertise in the design and conduct of these drug safety research studies, and in the analysis and interpretation of the data. Our scientific staff of experienced epidemiologists, analysts, and researchers provide high quality information that is capable of meeting the expectations and approval of scientific reviewers and regulators.



As a UnitedHealth Group company, i3 Drug Safety is part of a worldwide health care service organization that uses innovation, integrity and commitment to prepare for the future - and you can prepare for yours with us. It's a rare combination for success that only a career with i3 Drug Safety can provide.





MULTIPLE OPPORTUNITIES AVAILABLE:



The Safety Coordinator is responsible for collecting and processing adverse event reports from clinical trials and post-marketing activities in accordance with company SOP's, sponsor requirements, regulations, and guidelines.



Responsibilities include receipt, tracking, and triage of adverse event reports. The Safety Coordinator will also be responsible for initial database entry. The Safety Coordinator will maintain adverse event files and tracking systems. In addition, the Safety Coordinator will assist with the generation of follow-up requests. Responsibilities also include distribution and tracking of safety letters to investigators. Activities will involve interaction with client personnel as well as with internal departments such as Medical Monitoring, Project Management, Data Management, Medical Writing, and Clinical Operations.



Diversity creates a healthier atmosphere: an equal opportunity employer, M/F/D/V.





Job Requirements:

Education: Bachelor's degree in life sciences, pharmacy, nursing, or other relevant degree

Experience: Three years experience in drug safety/pharmacovigilance

Additional Qualifications: Ability to learn and apply SOPs and FDA regulations pertaining to clinical trials and post-marketing activities. Ability to establish effective relationships with sponsors, as well as team members. Ability to successfully prioritize and work on multiple tasks. Effective written and verbal communication skills. Computer proficient.