Product Integrity Specialist

Essential Functions:

• 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.

• Case entry of electronic correspondence

• Create and run reconciliation reports as needed.

• The Product Integrity Specialist can confidently identify any new or follow-up Adverse Event details and report to appropriate contacts.

• The Product Integrity Specialist can confidently identify any new or follow-up Product Complaint details and report to appropriate contacts.

• 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.

Necessary Skills and Abilities:

• Excellent English language skills especially verbal and written (including proofreading) communication skills.

• Ability to write fluent and grammatically correct American English.

• 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.

• Ability to organize and prioritize in quickly changing environment within resource constraints.

• Ability 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.

Educational Requirements:

• Pharmacy Technician, Veterinary Technician, Life Science Grad, or other Healthcare related equivalent required.

Experience Requirements:

• 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.

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