Role overview

Qualifications

Minimum Bachelor’s degree in Life Science
RN, BSN, BS, BS Pharm, PharmD or advanced degree preferred
2-4 years clinical experience or 2-3 years clinical experience and 1-year pharmacovigilance experience
Nursing experience and preferably experience with critical care/ICU/Cardiac/ER

Responsibilities

Conducting oversight of vendors to ensure collection, assessment, and processing of adverse event information (post marketing) is performed in a compliant and timely manner
Supporting and participating in audits and inspections as needed
Developing knowledge and expertise to initiate mentoring of MSA’s in vendor management
Supporting development of materials and delivering training in conjunction with the vendor

Key facts

Remote from: Illinois (USA)
Fixed term
Senior (5-10 years)
Client Service Specialist (Customer Care)
English

Hard skills

Pharmacovigilance Case Assessment Regulatory Compliance Project Management Vendor Management Project Collaboration Critical Care Cardiac Rhythm Agility

Other skills

Quality Assurance
Communication
Accountability
Training And Development

About the company

US Tech Solutions

Human Resources, Staffing & Recruiting

USTECH SOLUTIONS is the largest privately owned diversity workforce partner with a global footprint. For 20+ years, we have partnered with leading MSPs and some of the world’s largest enterprises to deliver a flexible workforce. We serve Fortune 500 giants and growing businesses alike, reinventing the role of humans in a digital workforce. ‘Reinventing Human’ is about connecting you with top talent and seamlessly integrating new hires into your programs through our next gen AI powered Talent platforms. As the largest private diversity supplier in the US, we champion inclusion and unlock hidden potential. We work with leading MSPs and are a trusted strategic partner to the world’s top brands. At USTECH SOLUTIONS, we're inverting the talent hiring pyramid by offering a range of solutions from curated talent pools, workforce management services, and IT services resourcing to IC compliance. Our legacy and close affinity to the computing industry has equipped us with the expertise and vision to provision AI platform solutions that help organizations to innovate faster. Considering Statement of Work? Meet US Tech Digital (ustechdigital.com). We're helping businesses achieve digital leadership through our tailored SOW solutions, utilizing market-leading technology products and our proprietary in-house developed platform solutions. Explore our full range of services and solutions by visiting our website: ustechsolutions.com

Company details

Company typeLarge

IndustryHuman Resources, Staffing & Recruiting

Company size1001 - 5000

Links

Website LinkedIn See all jobs

Your match analysis

See how your profile stacks up against this role.

We compared the job requirements to your profile to show where you're strong and where you fall short.

Job description

Duration: 12 Months Contract
Remote Role

Job Description:

Provides medical support with emphasis on the intake of medical product experiences and processing standard communication requests.
Acts as a liaison with Quality Assurance for product quality problems where an adverse event is involved. Works with Customer Service to provide standard information and product replacement as necessary.
Provides assistance to the medical and Client community with standard information that is from the package insert or information from the standard letter database that deals with labeled and specific off-label information/indications.

Responsibilities:

Conducting oversight of vendors to ensure collection, assessment, and processing of adverse event information (post marketing) is performed in a compliant and timely manner to comply with global regulations including: Seriousness assessment, Labeling, Causality Initial and Follow-up.
Conducting oversight of vendors to ensure company standards for quality, compliance and
productivity are met. Remaining current on knowledge and skills required for case processing.
Supporting vendor case quality, case processing metrics and agility using the core
leadership attributes: Agile and Accountable; Clear and Courageous; Make Possibilities Real; All for One Decide Smart and Sure.
Supporting and participating in audits and inspections as needed.
Developing knowledge and expertise to initiate mentoring of MSA’s in vendor management.
Supporting development of materials and delivering training in conjunction with the vendor,
including train-the-trainer, special-topics, refresher, and internal trainings as needed.
Other duties may be assigned based on the need or work requirement of the organization.

Experience:

Nursing experience and preferably experience with critical care/ICU/Cardiac/ER.
Pharmacovigilance experience preferred.
2-4 years clinical experience or 2-3 years clinical experience and 1-year pharmacovigilance experience.
Demonstrates ability to lead project work. Proven success in results-driven process management.
Demonstrates ability to work collaboratively in team environment.
Demonstrates understanding of the changing regulatory environment and impact to case management process.
Core knowledge of industry regulations (ICH, FDA, EMEA, MHRA).
Competent in case processing processes, procedures, conventions.

Education:

Minimum Bachelor’s degree in Life Science. RN, BSN, BS, BS Pharm, PharmD or advanced degree preferred.

About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

AI Statement: By applying, you acknowledge that AI-assisted tools may be used during hiring.