Patient Safety Quality Analyst

Yoh has a contract opportunity for a Patient Safety Quality Analyst to join our client in Wilmington, DE.

Job Responsibilities:
- Contribute to scientific, technical or Patient Safety activities for systems or processes across the Patient Safety Regions
- Ensure compliance with global and local procedural documents and local implementation of Patient Safety objectives, policies, processes and procedures
- Review safety data output for accuracy and completeness prior to submission to internal and external sources
- Contribute to the development and implementation of new safety-related systems, processes and procedures across Regions to prevent future late reporting from clinical, regulatory and marketing for inclusion in safety reports to regulatory authorities
- Support regulatory inspections and internal audits
- Executes special database queries to prepare additional reports required by FDA for inclusion in US periodic safety report submissions, and coordinate with other Regional Patient Drug Safety groups to ensure that all systems-related documents are acceptable for submissions to FDA
- Participates in cross-functional project team meetings to provide guidance to contributors of documents for submission to regulatory authorities
- Develop and execute user testing as required by company SOPs
- Demonstrate ability to effectively coordinate cross-functional projects and manage timelines
- Maintain local internal compliance and external reporting schedules

Job Qualifications:
- Bachelor's Degree level in biosciences or an appropriate healthcare, IS/IT or pharmaceutical industry background
- Minimum two (2) plus years of experience
- Experience in analysis, design, and development experience with Business Objects, Xcelsius, Oracle, SQL Server, &/or XML a plus; Experience with Windows Operating system, MS Applications (eg PowerPoint, Excel, Word, Internet Explorer) required
- Experience with providing end-user support and training, preparing technical documentation, preparing user acceptance test scripts, running test scripts, experience in preparing reporting data, demonstrated problem solving and organizational skills
- Able to work with clients to understand work processes, gather information, document requirements and translate these into functional requirements
- Basic competence with medical and therapeutic terminology
- Able to work independently and as part of a team, guided by procedures, with appropriate support
- An understanding of the international regulatory requirements
- Maintains high ethical standards, including a commitment to company values and behaviors
- Fluent in English

Discover all that's possible with Yoh. Apply now.

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our leading HR Solutions.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

Tax Term: CON_W2

J2W: SCIENTIFIC; J2W: CLINICAL; J2W: INFOTECH

MONJOB

J2WNWPHA

Ref: 1021080

SFSF: LS