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    Local Person For Pharmacovigilance (Lppv)

    Pharmalex
    2-4 years
    Not Disclosed
    Poland
    10 Jan. 3, 2025
    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

    Here’s a revised version of your text for improved clarity and professionalism:

    We’re Growing—Grow With Us!
    Are you seeking a dynamic role with daily challenges and opportunities for growth? Look no further!

    PharmaLex is a global leader in consulting services for the pharmaceutical industry. We specialize in drug and medical device approvals, market development, and comprehensive product lifecycle management.

    We are currently seeking a Local Person for Pharmacovigilance (LPPV) based in Poland. This remote role offers an exciting opportunity to manage and maintain local pharmacovigilance systems while collaborating with global teams.

    Local Person for Pharmacovigilance (LPPV)

    Location: Remote (Poland)
    Experience Required: Proven expertise in local pharmacovigilance activities

    Your Responsibilities

    • Serve as the primary pharmacovigilance contact for the Competent Authority in Poland, including 24/7 availability if legally required.
    • Act as a liaison between the EU-QPPV/Global PV team and the local regulatory authority.
    • Establish and manage the local pharmacovigilance system.
    • Conduct local literature searches and manage Individual Case Safety Reports (ICSRs).
    • Perform PV intelligence screening and maintain the local Pharmacovigilance System Master File (PSMF).
    • Oversee local organized data collection and manage local Pharmacovigilance Agreements (PVAs).
    • Adapt and submit Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs).
    • Conduct local signal detection and implement additional risk minimization measures.
    • Review materials related to local post-authorization safety.
    • Provide first-level medical information and Product Quality Complaint (PQC) support.
    • Participate in PV audits and inspections.
    • Submit monthly reports on the status of the local PV system.
    • Ensure PV training for affiliate employees, service providers, and third parties.

    Your Profile

    • Education: University degree in Medicine, Pharmacy, or Life Sciences.
    • Experience:
      • Several years of experience and in-depth knowledge of pharmacovigilance operations.
      • Expertise in global and local legislative and non-legislative PV guidelines.
      • Hands-on experience with tasks performed by pharmacovigilance teams.
      • Knowledge of Standard Operating Procedures (SOPs) at both global and local levels.
    • Skills:
      • Strong organizational abilities to manage multiple tasks and coordinate resources effectively.
      • Analytical problem-solving skills with the ability to develop practical solutions.
      • Adaptability to handle challenging and unfamiliar situations.
      • Team player with excellent communication and interpersonal skills.
      • High sense of responsibility and commitment to quality work.
    • Languages: Proficiency in Polish is mandatory, along with a strong command of English.

    Why Join PharmaLex?

    • Be part of a global leader in pharmaceutical consulting services.
    • Work remotely in a collaborative and innovative environment.
    • Gain opportunities for professional growth and skill development.

    If this opportunity excites you, submit your application online, including your earliest possible start date, visa requirements (if applicable), and salary expectations.

    Contact Us:
    Feel free to reach out for further details about the role.

    Note: Agencies are welcome to contact us only by prior agreement regarding this specific job opportunity.

    Let me know if additional changes are needed!

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