Position Title: Clinical Medical Services Specialist 
Work Location: 100% Remote
Assignment Duration: 12 Months
Work Schedule: Central Standard Time business hours from 7:00 AM to 4:00 PM CST.
Work Arrangement: Remote

Position Summary: This is a vendor oversight position focused on post-marketing pharmacovigilance (PV) case processing. The role supports oversight of Individual Case Safety Report (ICSR) processing activities completed by The Organization's external pharmacovigilance vendor.

Background & Context: The team oversees a large vendor organization located in India consisting of more than 600 case processors across three locations. The position serves as a liaison between The Organization and the vendor while ensuring adherence to pharmacovigilance regulations, guidelines, internal standards, and case processing conventions.

Key Responsibilities:
• Performing quality reviews of vendor-processed cases, identifying issues, providing feedback, and ensuring corrections are completed appropriately.
• Supporting vendor inquiries related to safety cases and reinforcing ICSR processing conventions, standards, and expectations.
• Partnering closely with Quality & Standards and other cross-functional teams across the organization.
• Supporting audit readiness activities, inspections, compliance initiatives, and process improvement efforts.
• Developing training materials, conducting micro-trainings, and delivering retraining based on quality findings.
• Includes both operational responsibilities and project-based work.

Qualification & Experience: Required:
• Strong pharmacovigilance experience.
• Experience performing quality reviews, quality oversight activities, and case quality assessments.
• Knowledge of pharmacovigilance regulations, guidelines, compliance requirements, and case processing conventions.
• Strong verbal and written communication skills.

Preferred:
• Extensive pharmacovigilance experience.
• Experience in post-marketing pharmacovigilance.
• Strong ICSR case processing experience.
• Vendor oversight or vendor management experience.
• Experience supporting inspections, audits, audit readiness activities, and compliance-related work.
• Experience creating, developing, and delivering training materials. • Experience providing coaching, retraining, process reinforcement, and feedback.
• Clinical backgrounds (Nursing backgrounds strongest fit).
• Clinical experience in ER, ICU, Coronary Care, or similar acute-care environments.
• PharmD or MD candidates with relevant pharmacovigilance experience.
• At least 1–2 years of clinical experience.
• Experience with ICSR vendor oversight. • Experience with quality oversight programs.
• Experience with Viva Safety. • Candidates comfortable researching regulations and providing case review rationale.
• Candidates with strong case processing experience transitioning into vendor oversight will be considered.
• An active RN license is not required. An active Pharmacist license is not required.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 40.00/hr.