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    Pharmacovigilance Associate

    Primevigilance
    2+ years
    Not Disclosed
    Remote
    10 Dec. 25, 2024
    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: Pharmacovigilance Associate

    Location: PrimeVigilance (Global: North America, Europe, Asia)

    About PrimeVigilance

    PrimeVigilance is a leading provider of pharmacovigilance and drug safety services to the pharmaceutical industry. Our global teams ensure the safety and efficacy of medicinal products throughout their lifecycle, helping protect patients and enabling healthcare professionals to make informed decisions.

    Key Accountabilities

    As a Pharmacovigilance Associate, your primary responsibilities will include:

    • Processing ICSRs:
      • Process Individual Case Safety Reports (ICSRs) in compliance with regulatory requirements, PrimeVigilance procedures, and client-specific guidelines.
      • Ensure that ICSRs are processed accurately and within the defined timelines.
    • Follow-up and Reporting:
      • Perform ICSR follow-up activities, ensuring all necessary information is gathered and reported.
    • Product Quality Complaints (PQCs):
      • Handle Product Quality Complaints and liaise with Quality Assurance to resolve issues related to product safety.
    • Coding and Documentation:
      • Apply MedDRA and WHO coding for case reporting and data classification.
    • Cross-Departmental Collaboration:
      • Work closely with other departments, such as Medical Information and Quality, to ensure smooth operations and efficient data handling.

    Qualifications

    • Educational Background:
      • A Life Science or Biomedical degree (e.g., Chemistry, Biology, Biotechnology, Veterinary Science) is required.
    • Key Skills:
      • Time Management & Organization: Excellent time management and organizational skills with the ability to manage multiple tasks simultaneously.
      • Attention to Detail: Strong focus on accuracy and attention to detail in all tasks.
      • Communication Skills: Strong interpersonal and communication skills, with the ability to work effectively within a team and interact with other departments.
    • Language Proficiency:
      • Advanced English skills, both verbal and written, at least at a B2 level.
      • Additional language skills are an advantage, especially in other widely spoken languages.
    • Technical Proficiency:
      • Advanced knowledge of MS Office (Word, Excel, PowerPoint) to manage data and reports effectively.

    Additional Information

    The Pharmacovigilance Associate position is an excellent opportunity to start and grow your career in Drug Safety and Pharmacovigilance. You will gain valuable experience in the handling and reporting of safety data, learning key skills in ICSR processing, coding, and product quality complaint management. With support from experienced professionals, you'll have the opportunity to advance your career in a growing field within the pharmaceutical industry.

    PrimeVigilance is committed to fostering a collaborative, diverse, and inclusive work environment where every team member can thrive.

    PrimeVigilance is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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