Sr. Pharmacovigilance Coordinator for i3 Drug Safety - Ann Arbor, MI (preferred)

Company:	UnitedHealth Group Company Profile \| Current Opportunities (14)
Job Location(s):	Ann Arbor
Employment Term:	Regular
Employment Type	Full Time
Start Date:	As soon as possible
Starting Salary Range:	Not Provided
Required Education:	Bachelor's Degree
Required Experience:	Open
Related Categories:	Healthcare - Pharmacy/Laboratory

Position Description

Sr. Pharmacovigilance Coordinator for i3 Drug Safety - Ann Arbor, MI (preferred) or Basking Ridge, NJ-328700

Description

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 management
Safety operations management inclusive of developing and generating system queries
Perform or coordinate electronic submissions (via Gateway or EV Post) or paper submissions of safety reports to regulatory authorities. This will include individual and aggregate safety reports.
Develop and maintain systems to ensure compliance with reporting requirements and submission tracking.
Provide training on safety reporting procedures to other employees as needed.
Participate in project launch through attendance of meetings and assist with development of Safety Monitoring Plans.
Attend project team meetings and Investigators' meetings as requested.
Develop and maintain a working knowledge of assigned projects and all applicable regulations.
Ensure compliance with company policies, procedures and standards.
Participate in the process of developing and review of SOPs.
Interact with other Ingenix functions, such as project management, field monitoring, data management, etc. to ensure the highest level of client satisfaction through successful execution of projects.

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.

Qualifications

Education:

Bachelor's degree in life sciences, pharmacy, nursing, or other clinical degree

Experience:

At least two years experience in drug safety/Pharmacovigilance in a CRO or pharma company

Additional Qualifications:

Previous experience with ARISg or other safety database
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: an 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.

Job Pharmacovigilance

Primary LocationUS-MI-Ann Arbor

Other LocationsUS-NJ-Basking Ridge

Organization i3 Drug Safety

Schedule Full-time

Number of Openings 1