PV Argus Business and System Contractor (REMOTE)

October 9, 2024

Company: Kelly

Industry: Private

Employment Type:- Full Time

Work Hours:- 8 Hours

Locations:- USA

Full Job Description:-

Work Shift – Days- Eastern Time Zone Hours

Work on day-to-day operations with the hosting vendor and managing SLAs (service level agreements) to ensure that outstanding tickets are resolved in a timely manner.
Works with PV Case Processing team to troubleshoot Case Processing and E2B reporting issues.
Support implementation of safety system enhancements and upgrades, including (but not limited to) involvement in project workshops, CRP testing, Dry Runs, UAT execution, Cutover and Post Go-live support.
Extensive experience with Argus Safety database

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Support PV Systems and Operations Team in optimizing case processing and global adverse event database (GAED) functionality. The individual will support the Argus Safety system, work with the team and the hosting vendor and ensure that requests for system issues, enhancements and other system changes are resolved in a timely manner.

Essential Responsibilities:

Work on day-to-day operations with the hosting vendor and managing SLAs (service level agreements) to ensure that outstanding tickets are resolved in a timely manner.
Works with PV Case Processing team to troubleshoot Case Processing and E2B reporting issues.
Serves as Argus business administrator and completes tasks including safety database queries, database maintenance and validation activities.
Manages and tracks the status of system change requests, enhancements and/or support efforts.
Support implementation of safety system enhancements and upgrades, including (but not limited to) involvement in project workshops, CRP testing, Dry Runs, UAT execution, Cutover and Post Go-live support.
Troubleshoots root cause of data discrepancies and use those findings to improve case processing efficiencies.
Contributes to testing of new system configurations
Reviews and performs impact assessment for requested changes
Gathers and documents user requirements for adhoc and custom reports
Perform adhoc queries of the database and work with vendor as needed to develop validated queries/reports
Maintains database user manual and safety system training materials
Contribute as needed in inspections and audits, including delivering database queries
Process ICSRs (data entry, QC, finalization and distribution) as required.

Qualifications/Requirements

Bachelor’s degree in a Life Sciences discipline, Nursing or Pharmacy
5+ years’ experience working within the Drug Safety/ Pharmacovigilance/Consulting domain including case processing experience, user requirements gathering and user acceptance testing.
At least 3 years of pharmacovigilance systems experience.
Extensive experience with Argus Safety database including experience with Argus Console, creating advanced conditions and generating reports and listings in Argus.
Ability to work in Eastern Time Zone
Experience with managing hosting vendor.
Strong knowledge of rules and regulations applicable to the Global Safety industry.
Attention to detail, results-oriented and persistent with excellent organizational skills.
Self-motivated and ability to work independently in a fast-paced environment, prioritize multiple tasks and ability to recognize time sensitivity.
Experience with full case processing workflow (e.g., assessing & triaging cases, data entry, quality check/review, follow up letter generation and submissions).
Ability to adapt to constant change and influence positive change effectively.
Team-oriented and responsive to customer needs.
Ability to understand technical documentation and execute associated procedures.
Act as Business System Administrator for the Global Computer System for Adverse Events (GCSAE) and as company contact for MedDRA subscription. Directs system development, maintenance and validation, in cooperation with the Global IT Department QMS & R&D QA QMS.

Why Kelly?

Kelly® puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly® as a firm with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety and flexibility of working on short term project engagements or prefer contract-to-hire or direct hire placement with our clients, apply with Kelly® to explore opportunities that suit your specific professional interests.

As a Kelly Services employee, you will have access to numerous perks, including:

Exposure to a variety of career opportunities as a result of our expansive network of client companies
Career guides, information and tools to help you successfully position yourself throughout every stage of your career
Access to more than 3,000 online training courses through our Kelly Learning Center
Weekly pay and service bonus plans
Group-rate insurance options available immediately upon hire*

Let us help advance your career today.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Engineering?

Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world’s most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we’re here to guide you to the next step in your engineering career.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.