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Quality Management Assistant (6 Months Student Position)

0-2 years
Not Disclosed
10 Oct. 17, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Company Description

We are PrimeVigilance, part of Ergomed PLC, a specialized mid-sized pharmacovigilance service provider established in 2008. We have consistently achieved global organic growth, with staff across Europe, North America, and Asia providing services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.

PrimeVigilance delivers top-notch support to our pharmaceutical and biotechnology partners, fostering long-lasting relationships and establishing ourselves as global leaders in the industry. We cover all therapy areas, including medical devices.

We are committed to investing in our staff through exceptional training and development opportunities. We prioritize employee experience, well-being, and mental health, recognizing that a healthy work-life balance is crucial for job satisfaction and high-quality client service.

Join us on this exciting journey to make a positive impact on patients' lives!

Job Description

Role and Responsibilities:

The Quality Management Assistant (QEs and CAPAs) will manage all activities related to tracking and administration of PrimeVigilance Quality Events (QEs) and Corrective and Preventative Actions (CAPAs). Responsibilities include, but are not limited to:

  • Accurately entering QE and CAPA data into the Quality Management Control System (QMCS) within specified timelines.
  • Assigning tasks related to QEs and CAPAs to the appropriate employees.
  • Reviewing task completion associated with QEs and CAPAs and escalating non-compliance as needed.
  • Generating and distributing reports from QMCS as required.
  • Monitoring the deviations mailbox and ensuring appropriate actions are taken.
  • Supporting the Quality Management Team with tasks such as administration, tracking, and management of PrimeVigilance Controlled Procedures and related training.
  • Reviewing and approving Access Requests to PrimeVigilance’s controlled systems.

Qualifications

Requirements:

  • Strong communication skills.
  • Experience in administrative work.
  • Advanced English proficiency (verbal and written).
  • Proficiency in all MS Office applications, including Word, Excel, and PowerPoint.

Additional Information

We prioritize diversity, equity, and inclusion, creating an equal-opportunity workplace that fosters a human-centric environment. We believe that our people are our greatest strength, leading to our ongoing success in improving lives.

We offer:

  • Internal training and career development opportunities.
  • A strong emphasis on personal and professional growth.
  • A friendly, supportive working environment.
  • Opportunities to collaborate with colleagues worldwide, with English as the primary company language.

Our core values are fundamental to how we operate. If they resonate with you, PrimeVigilance could be the perfect place for you!

  • Quality
  • Integrity & Trust
  • Drive & Passion
  • Agility & Responsiveness
  • Belonging
  • Collaborative Partnerships

We look forward to welcoming your application!