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    Pharmacovigilance Specialist - French Speaking

    Pharmalex
    0-2 years
    Not Disclosed
    Remote
    10 Oct. 29, 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

    Your Job:
    As a Pharmacovigilance Specialist, you will manage safety-relevant information from various sources, ensuring compliance and high-quality processing. Your responsibilities include:

    • Safety Information Management: Handle safety-relevant information from spontaneous reports, literature, clinical studies, and medical inquiries.
    • Case Processing: Perform data entry and translation between French and English, including quality checks of translations.
    • Quality Assurance: Conduct quality checks on data entry (without case assessment).
    • Literature Screening: Screen local scientific literature for safety-relevant publications and create search algorithms for literature reviews.
    • ICSR Support: Assist in the creation and processing of Individual Case Safety Reports (ICSRs) for adverse drug reactions from clinical trials and literature, ensuring reporting to competent authorities.
    • Documentation: Maintain accurate documentation of case processing at both company and case levels.
    • Follow-up Tracking: Support the generation and tracking of follow-up requests.
    • Monthly Reporting: Prepare and perform monthly reconciliations and PV intelligence for clients.
    • Tracker Maintenance: Update and maintain various PV trackers, including case trackers and monthly report trackers.
    • Translation Quality Assurance: Ensure high-quality translations in the context of case processing.

    Your Profile:

    • Education: Medical Documentation Specialist or University degree in Life Sciences.
    • Experience: 0-2 years of experience in pharmacovigilance or related fields, with a strong understanding of GxP and GVP.
    • Knowledge: Familiarity with relevant legislative guidelines and project-related SOPs (internal and client-specific).
    • Skills: Strong organizational abilities with project management experience, excellent verbal and written communication skills in both French and English.
    • Attributes: Ability to work independently and collaboratively, strategic and analytical thinking, adaptability, and flexibility.

    If you are interested in this exciting opportunity to join our PharmaLex team, we look forward to receiving your application, including your earliest possible starting date, any visa requirements, and salary expectations.

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