Clinical Medical Services Specialist III # 26-13898
US Tech Solutions
Duration: 12 + months contract 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.
- 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
- Nursing experience and preferably experience with critical care/ICU/Cardiac/ER. Pharmacovigilance experience preferred.
- 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. - 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.
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 . 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.
Vacancy posted 18 hours ago
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