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Pharmacovigilance Associate

0-2 years
Not Disclosed
10 Nov. 8, 2024
Job Description
Job Type: Full Time Remote 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

About PrimeVigilance

PrimeVigilance, part of Labcorp Drug Development, is a leader in providing comprehensive pharmacovigilance and drug safety solutions. Our Individual Case Safety Report (ICSR) team operates across North America, Europe, and Asia, working to ensure the safety of pharmaceutical products and protecting public health.


Job Overview

The Pharmacovigilance Associate role provides an exciting opportunity to start and develop your career in Drug Safety. You will be responsible for processing Individual Case Safety Reports (ICSRs) and handling product quality complaints, ensuring compliance with applicable regulations and PrimeVigilance procedures. This is an excellent role for someone passionate about pharmacovigilance and eager to contribute to patient safety.


Key Accountabilities

  • ICSR Processing:
    Process Individual Case Safety Reports (ICSRs) in accordance with applicable regulations, PrimeVigilance procedures, and client-specific requirements and timelines.

  • ICSR Follow-up:
    Perform follow-up activities to ensure the complete and accurate reporting of adverse events.

  • Product Quality Complaint Handling:
    Handle product quality complaints and collaborate with the Quality Assurance department as necessary.

  • MedDRA & WHO Coding:
    Code adverse events using MedDRA and WHO coding systems, ensuring accurate and timely reporting.

  • Cross-department Collaboration:
    Work closely with other departments such as Quality and Medical Information to address inquiries and assist in the processing of safety data.


Qualifications

  • Education:
    A Life Science or Biomedical background (e.g., chemistry, biology, biotechnology, veterinary science) is required.

  • Skills:

    • Strong time management, delegation, and organizational skills.
    • Ability to multitask and pay close attention to detail while working in a fast-paced environment.
    • Excellent interpersonal and communication skills to collaborate with colleagues and stakeholders.
    • Proficiency in MS Office applications.
  • Language Requirements:

    • Advanced English language skills, both verbal and written (minimum B2 level).
    • Additional language skills are a plus.

Why PrimeVigilance?

PrimeVigilance offers a collaborative environment where you can start and grow your career in pharmacovigilance. With a global presence and a dynamic team, this is an excellent opportunity for those looking to make a meaningful impact in drug safety.