Manager, Pharmacovigilance for i3 Drug Safety - Ann Arbor, MI-329222
Description
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 seeking a Manager, Pharmacovigilance to work in our Ann Arbor, MI office.
We are seeking highly organized team players to work in a fast-paced environment. As a Manager, Pharmacovigilance, you would also enjoy high visibility within the company, a close-knit team, and growth opportunities.
Responsibilities:
- Designing and planning the work strategy of the Pharmacovigilance Department
- Implementing this work strategy by delegating tasks to members of the Pharmacovigilance Department
- Monitoring and managing the daily activities of members of the Pharmacovigilance Department including authorizing time out of the office and completing performance appraisals
- Organizing and providing training sessions for project teams and other members of the Pharmacovigilance Department to ensure quality of all safety data
- Designing and implementing procedures to ensure the smooth running of the Drug Safety Department. e.g. ensuring the accuracy and completeness of safety information entered into the safety database or tracking systems and preparing safety reports for submission to regulatory authorities
- Responsibility for the systems and processes relating to AE information management and global regulatory submissions, including overall responsibility for the i3 safety database and electronic submissions (via Gateway, EV Post or EVWEB) or paper submissions of safety reports to regulatory authorities (includes individual and aggregate safety reports)
- Maintaining systems to ensure compliance with reporting requirements and submission tracking
- Managing and maintaining the i3 safety database through fulfillment of the role of Application Administrator as defined within the i3 Drug Safety SOPs
- Developing and maintaining project-specific configurations within the i3 safety database
- Participating in routine safety database patches and upgrades
- Participating in routine MedDRA, WHO drug, and synonym dictionary updates to the safety database
- Developing and executing performance qualification (PQ) scripts for safety database upgrades/ changes
- Ensuring systems and processes are in place for regulatory compliance with ICH E2B electronic submission of adverse event reports to the EudraVigilance database and other Health Authority databases, including establishing registration, testing and production status for each project
- Ability to effectively prioritize and work on multiple tasks
Qualifications
Qualifications:
- Bachelor's degree in life sciences, pharmacy, nursing, or other clinical degree
- At least five years experience in drug safety/Pharmacovigilance in a CRO or pharma company
- Oracle certified DBA a plus
- 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: 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
Organization i3 Drug Safety
Schedule Full-time
Number of Openings 1
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