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Quality Assurance Associate

Primevigilance
PrimeVigilance
2+ years
Not Disclosed
10 April 24, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Quality Assurance Associate
Location: Belgrade, Serbia
Employment Type: Full-time
Department: PV QA


About the Company:

PrimeVigilance, part of the Ergomed Group, is a leading mid-size pharmacovigilance service provider established in 2008. Operating globally with staff across Europe, North America, and Asia, the company delivers top-tier services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. PrimeVigilance collaborates with a diverse range of pharmaceutical and biotech clients, supporting all therapy areas, including medical devices. With a strong emphasis on training, mental well-being, and work-life balance, PrimeVigilance fosters a culture where employee satisfaction translates into quality client outcomes.


Job Responsibilities:

  • Support QA operations to ensure audits are scheduled, developed, managed, maintained, and delivered in line with internal procedures.

  • Host and support internal/external audits, including routine, due diligence, and qualification audits by clients, third parties, and regulatory authorities.

  • Assist PrimeVigilance teams before, during, and after audits or inspections.

  • Maintain audit-related trackers and SharePoint documentation.

  • Assist with scheduling audits and inspections by clients or regulatory authorities.

  • Track CAPAs from vendor audits and assist with CAPA review and facilitation.

  • Maintain and update audit documentation, trackers, and internal risk assessments.

  • Contribute to global audit CAPA tracker and support ad hoc tasks as assigned by QA leadership.


Required Qualifications:

  • University degree in a scientific discipline or equivalent industry experience


Desired Candidate Attributes:

  • Detail-oriented and organized with a strong understanding of audit processes

  • Comfortable working cross-functionally and supporting internal and external stakeholders

  • Ability to manage multiple tasks and maintain audit documentation

  • Effective communication and teamwork skills


What We Offer:

  • Training and career development opportunities

  • Emphasis on personal and professional growth

  • Supportive and friendly work environment

  • Global collaboration with English as the working language

  • Inclusive company culture that values diversity, belonging, and trust


Core Values:

  • Quality

  • Integrity & Trust

  • Drive & Passion

  • Agility & Responsiveness

  • Belonging

  • Collaborative Partnerships