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Senior Pharmacovigilance Coordinator
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Country: USA
Location: New Jersey-Northern basking ridge, NJ 07920
Total applied: 40 |
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Senior Pharmacovigilance Coordinator
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 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. The Senior Pharmacovigilance Coordinator is responsible for collecting, documenting and processing adverse event reports from clinical trials and post-marketing activities in accordance with company SOP's, sponsor requirements, regulations, and guidelines.Responsibilities also include safety database data entry with development of the safety narrative. The Coordinator will also maintain adverse event files and tracking systems. In addition, the Coordinator is responsible to generate follow-up requests, which may involve telephone contact with reporters. The Safety Coordinator will also review data entry of peer reports to ensure quality entry and appropriate output. 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. Education: Bachelor's degree in life sciences, pharmacy, nursing, or other clinical degree Experience: Two 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. 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.
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