Clinical Medical Services Specialist III # 26-13898

US Tech Solutions; North Chicago (IL); On-site; USD 70,000 - 90,000; Full time

Job summary

US Tech Solutions is seeking a qualified candidate to provide medical support focused on processing adverse event information while ensuring compliance with global regulations. Responsibilities include vendor oversight, support in quality metrics, and conducting training for vendor staff.

The ideal candidate will possess nursing experience with a strong understanding of critical care environments and regulatory frameworks, along with a Bachelor's degree in Life Science.

Qualifications

• 2-4 years clinical experience or 1 year pharmacovigilance experience.
• Demonstrates understanding of regulatory impacts on case management.

Responsibilities

• Provide medical support for processing communication requests.
• Oversee vendors to ensure compliance and timeliness of adverse event information collection.
• Support vendor case quality and processing metrics.
• Participate in audits and inspections.
• Mentor MSAs in vendor management.
• Deliver training materials in collaboration with vendor.

Skills

Nursing experience

Critical care/ICU/Cardiac/ER experience

Pharmacovigilance experience

Project management

Team collaboration

Regulatory knowledge (ICH, FDA, EMEA, MHRA)

Case processing competency

Education

Bachelor's degree in Life Science

RN, BSN, BS, BS Pharm, PharmD or advanced degree

Job description

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, working with Customer Service to provide standard information and product replacement as necessary.
• Provides assistance to the medical and client community with standard information from the package insert or standard letter database concerning 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 the 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.

Qualifications / Skills

• 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 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.