UnitedHealth Group is among the most ambitious Fortune 25 companies you'll ever meet. Through our family of businesses, we're working to make the health care system perform better for more people, in more ways than ever.

Simply put, we think the entire system can be greater than it's ever been. And that drives us to work harder, aim higher, and expect more from one another.

Here, you'll be empowered to make an immediate impact for millions of others. And you'll achieve more than you ever expected. How does that fit with your plans?

Job Description

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 provides comprehensive pharmacoepidemiology and pharmacovigilance services. Rooted in scientific rigor, using innovative methods and proven expertise, i3 Drug Safety's services can be customized for all scopes of work, from safety surveillance and risk assessment in clinical development to post-approval pharmacovigilance. 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.
 
We are currently recruiting for a Pharmacovigilence Coordinator - Regulatory Authority Submissions to work in our Ann Arbor, MI office. 
 
The Pharmacovigilance Coordinator is responsible for submission of safety reports to relevant regulatory authorities.  The Coordinator will also assist with the maintenance of systems to ensure compliance with reporting requirements and submission tracking.
 
Responsibilities    

• Perform submissions of safety reports to regulatory authorities
• Assist with the maintenance of systems to ensure compliance with reporting requirements and submission tracking
• Assist with preparation of safety reports including Periodic Safety Update Reports and FDA Periodic Reports for marketed products, as well as Annual Safety Reports for investigational products
• Attend project team meetings
• Develop and maintain a working knowledge of assigned projects and all applicable regulations
• Ensure compliance with company policies, procedures and standards

 


Job Requirements

Qualifications 

• Bachelor's level degree in health care
• One to two years experience in a regulatory environment, preferably within pharmacovigilance
• Ability to learn and apply SOPs and worldwide regulations pertaining to pharmacovigilance
• Ability to establish effective relationships with sponsors, as well as team members
• Ability to successfully prioritize and work on multiple tasks
• Effective written communication skills
• Computer proficient

Diversity creates a healthier atmosphere: equal opportunity employer:  M/F/D/V
UnitedHealth Group is a drug-free workplace.  Candidates are required to pass a drug test before beginning employment.