Clinical Medical Services Specialist III (remote)

Clinical Medical Services Specialist III
1 year initial contract
This role will be 100 % remote (US candidates only, must be able to work without visa sponsorship)
Hourly Rate: $37-40/hr (individual medical benefits available at a cost)
 
The Clinical Medical Services Specialist III 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. 

Job Description:

• 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 leadership attributes: Agile and Accountable; Clear and Courageous; Make Possibilities Real; 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/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.

People are our business worldwide
 
Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.