Clinical Medical Services Specialist III - Randstad USA

job summary:

As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A current top partnership with a research-driven biopharmaceutical company is known as a powerhouse that aims to develop treatments for difficult-to-cure diseases. This renowned employer has created 32 products, including Humira and Lupron, that have highly impacted lives across the globe. If you're looking to stand out in your field and lead the way to innovative therapies, this position is for you!

 
location: North Chicago, Illinois
job type: Contract
salary: $43.00 - 51.30 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:

• 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 lay 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 (clinical and 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 Company core leadership attributes: Agile and Accountable; Clear and Courageous; Make Possibilities Real; All for One Company; Decide Smart and Sure.
• Supporting development of materials and delivering training in conjunction with the vendor, including train-the-trainer, special-topics, refresher, and internal Company trainings as needed.

 
qualifications:

• Minimum: Bachelor's degree in Life Science. RN, BSN, BS, BS Pharm, PharmD or advanced degree preferred. Candidates lacking the appropriate degree but with previous pharmaceutical experience may be considered.
  • 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.

 
skills: FDA, Pharmacovigilance, Drug Safety, ICH Regulations, AD (Adverse Events)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

This posting is open for thirty (30) days.