Bilingual Product Quality Specialist

4 weeks ago


Windsor, Ontario, Canada ProPharma Group Full time

Company Overview:

ProPharma Group has dedicated the last two decades to enhancing patient health and wellness by offering expert guidance that empowers organizations in biotechnology, medical devices, and pharmaceuticals to confidently progress scientific innovations and launch new treatments. As the leading Research Consulting Organization (RCO) globally, ProPharma collaborates with clients through a comprehensive advise-build-operate framework throughout the entire product lifecycle.

Position Summary:

The role of the Product Integrity Specialist is vital in assessing data related to Product Complaints and Adverse Events. This position involves creating cases, coordinating product returns, conducting follow-ups via telephone, generating related correspondence, and providing additional services for select clients. The Specialist is also responsible for preparing and reviewing reconciliation reports as required by clients. This role demands exceptional technical skills in proofreading and managing various processes and timelines within a regulated environment.

Key Responsibilities:

  • Review cases for Product Complaints (PC) and Adverse Events (AE) initiated by Medical Information to determine necessary actions:
    • Coordinate product retrievals for designated client companies, if applicable.
    • Make outbound follow-up calls to finalize Product Complaint reports and gather additional information as requested by clients.
    • Draft letters in response to Product Complaints as instructed by clients.
  • Provide additional contracted services for PC and AE for selected client companies.
  • Enter electronic correspondence into the system.
  • Generate and manage reconciliation reports as needed.
  • Identify and report new or follow-up Adverse Event details to appropriate contacts.
  • Identify and report new or follow-up Product Complaint details to appropriate contacts.
  • Offer administrative support to the Medical Information group as required.
  • Manage Product Integrity inboxes.
  • Update existing Product Complaint and Adverse Event cases as necessary.
  • Handle inbound calls and check voicemails.
  • Perform other duties as assigned.

Essential Skills and Qualifications:

  • Fluent in English and French, with strong verbal and written communication skills, including proofreading.
  • Ability to write clear and grammatically correct American English and Canadian French.
  • Familiarity with medical terminology, regulations, and industry standards.
  • Strong interpersonal skills, including empathetic customer service abilities.
  • Accurate and proficient data entry skills.
  • Capability to multitask with attention to detail within tight deadlines.
  • Proactive approach with the ability to independently identify issues and propose effective solutions.
  • Strong organizational and prioritization skills in a dynamic environment.
  • Willingness to learn and take direction.
  • Receptive to constructive feedback.
  • Self-motivated with a strong initiative and willingness to seek additional projects.
  • Ability to work independently and collaboratively within a team.
  • Highly skilled in computer applications, including Microsoft Office and Adobe Acrobat, with experience in document management systems.

Educational Background:

  • Qualifications such as Pharmacy Technician, Veterinary Technician, Pharmacy Assistant, Life Science Graduate, or other healthcare-related equivalents are required.
  • Alternatively, a minimum of 1-3 years of experience in a related field is acceptable.

Experience Requirements:

  • At least 1-3 years of prior experience in an administrative or data entry role.
  • Experience in the medical or pharmaceutical industry, particularly in Medical/Drug Information, Pharmacovigilance, Product Complaints, and/or Quality Assurance, is preferred.

ProPharma Group is committed to fostering a diverse, equitable, and inclusive workplace where every individual can express their authentic self. We encourage our employees to unleash their innovative, collaborative, and entrepreneurial spirits. As an Equal Opportunity Employer, we provide a safe environment where all employees are empowered to thrive.



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