Sr. Document Management Specialist for i3 Drug Safety - Ann Arbor, MI

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 Document Management Specialist is responsible for the establishment and administration of the pharmacovigilance document management strategy for document processing, distribution, retention, retrieval and overall control. Specific responsibilities include:

• Coordinate department SOP related activities including authoring new procedures, initiating modifications, generating change control histories, e-test creation, and performing analysis across regional and global documents.
• Facilitate the capture, tracking and reporting of department metrics for the department leadership and management review.
• Assist with maintaining current client-specific personnel training records. Generates department training management reports and follows-up on any outstanding issues or records. Assists with delivering new employee orientation training.
• Establish, maintain and manage existing department-specific common drives and safety data repositories. Input and maintain information within cross-functional systems and shared drives.
• Serve as business liaison with corporate records information management function. Provides record retention input, perform risk assessments, and ensure documentation compliance with established
• Processes and archives all safety surveillance documents per supplier oversight and governance parameters.
• Provides subject matter expertise for documentation preparation and inspection readiness activities.
• Collaborate with regional safety departments (EU, Asia/Pac) to ensure proper tracking, review and approval of global working group deliverables.
• Effectively research, identify and support continuous improvement in processes or systems related to document management; as well determining local, regional and global impact.

Qualifications:

* Bachelor's degree with 3 years pharmaceutical or CRO industry experience, and 2 years pharmacovigilance strongly preferred.

* Documentation management experience in the pharmaceutical industry strongly preferred.

* Ability to utilize high-level end-user computer skills (for example, word processing, tables and graphics, spreadsheets, presentations, and templates)

* Strong knowledge of personal computers and database management software used in conjunction with established departmental operating procedures. Documentum experience highly desirable.

* Knowledge of pharmaceutical industry regulations and related quality/compliance principles; familiar with good documentation-industry practices.

* Ability to manage projects and tasks independently with limited management oversight.

* Effective communication, writing and interpersonal skills and the ability to interface across multiple departments and with external stakeholders.

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. In addition, employees in certain positions are subject to random drug testing.