Product Integrity Specialist

About the role

This Product Integrity Specialist position is critical in evaluating data for Product Complaints and Adverse Events. The Product Integrity Specialist may create cases, coordinate product retrievals, perform follow-ups via phone, generate follow-up related correspondence and complete additional services for select clients.

Responsibilities

• Perform case review for Product Complaint (PC) and Adverse Event (AE) cases created by Medical Information to determine next action(s) required (if applicable)
• Coordinate Retrieval for select client companies, if applicable
• Place outbound follow up calls to complete Product Complaint reports and collecting additional information as requested by the client
• Create letters in response to Product Complaints as directed by the client
• Additional contracted PC and AE services for select client companies
• Create and run reconciliation reports as needed
• Provide administrative support for MI group as needed
• Manage Product Integrity inbox(es)
• Update existing Product Complaint and Adverse Event cases as appropriate
• Answer inbound calls and check voicemails
• Other duties as assigned

Requirements

• Excellent English language skills especially verbal and written (including proofreading) communication skills
• Working knowledge of medical terminology, regulations, and industry standards
• Excellent interpersonal skills including empathetic customer service skills
• Accurate and proficient data entry skills
• Ability to multi-task with attention to detail within restrictive timeframes
• Proactive with demonstrative ability to independently identify problems and suggest effective solutions
• Able to organize and prioritize in quickly changing environment within resource constraints
• Able to take instruction and learn
• Receptive to constructive feedback
• Self-motivating. Ability to demonstrate initiative and internal drive
• Willingness to seek out additional workload projects
• Effectively work independently and as part of a team
• Highly proficient in computer applications, including Microsoft Office software platforms and Adobe Acrobat, and experience using a document management system
• Aptitude to learn other computer systems including inquiry handling database

Qualifications

• Pharmacy Technician, Veterinary Technician, Life Science Grad, or other Healthcare related equivalent required
• Minimum 1-3 years’ previous experience in an administrative or data entry role
• At least 1-3 years’ experience in medical or pharmaceutical industry field especially in Medical/Drug Information, Pharmacovigilance, Product Complaints, and/or Quality Assurance preferred