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Pharmacovigilance Associate

0-2 years
Not Disclosed
10 Nov. 8, 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

Job Title: Pharmacovigilance Associate

Location: [Insert Location]
Company: PrimeVigilance
Department: Drug Safety / Pharmacovigilance


About PrimeVigilance

PrimeVigilance, a Labcorp Drug Development company, offers world-class services in Pharmacovigilance and Drug Safety. Our goal is to support our clients by ensuring the safety of their products throughout the entire lifecycle. With teams based across North America, Europe, and Asia, PrimeVigilance offers an exciting opportunity for individuals looking to start and grow their careers in the field of Pharmacovigilance.

As part of our team, you will work with global pharmaceutical, biotech, and medical device companies, helping to ensure patient safety while developing your skills in a dynamic, fast-paced environment.


Job Overview

The Pharmacovigilance Associate will be a key member of PrimeVigilance’s Individual Case Safety Report (ICSR) team. You will be responsible for processing adverse event reports and managing key safety data in compliance with regulatory requirements and client-specific procedures. The role requires close attention to detail, strong organizational skills, and the ability to collaborate across multiple departments to ensure accurate reporting and compliance.


Key Accountabilities

  • ICSR Processing:
    Process Individual Case Safety Reports (ICSRs) in line with regulatory guidelines, PrimeVigilance's procedures, and client-specific timelines.

  • Follow-up & Documentation:
    Handle follow-ups on adverse event cases to ensure complete and accurate documentation of safety reports.

  • Product Quality Complaint Handling:
    Assist with handling Product Quality Complaints, coordinating with Quality Assurance to ensure proper reporting and resolution.

  • Medical Coding:
    Perform MedDRA and WHO drug coding to categorize adverse events and other safety-related data accurately.

  • Cross-department Collaboration:
    Work closely with Quality, Medical Information, and other departments to resolve issues and ensure accurate case management.


Qualifications

  • Education:
    A Life Science or Biomedical background, with a healthcare-related degree such as in chemistry, biology, biotechnology, or veterinary science.

  • Skills:

    • Time Management & Organization: Ability to prioritize and manage multiple tasks in a fast-paced environment.
    • Attention to Detail: Strong focus on accuracy when processing ICSR data.
    • Communication Skills: Strong interpersonal and written communication skills in English (at least B2 level).
    • Language Skills: Additional language skills are a plus.
    • Technical Skills: Proficient in MS Office and other software applications commonly used in pharmacovigilance.

Preferred Experience

  • Prior experience in Pharmacovigilance or Drug Safety is a plus, but not essential.
  • Knowledge of regulatory requirements in pharmacovigilance, including EU and FDA guidelines, is advantageous.

Why Join PrimeVigilance?

PrimeVigilance offers excellent career development opportunities in Drug Safety. You will have the chance to work in a global, collaborative environment, gain hands-on experience in pharmacovigilance processes, and contribute to the safety of pharmaceutical and healthcare products.