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    Local Person For Pharmacovigilance (Lppv)

    Pharmalex
    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 the Local Person for Pharmacovigilance (LPPV), you will serve as the primary contact for pharmacovigilance with the Competent Authority in the Czech Republic. Your responsibilities include:

    • Primary Contact: Act as the main point of contact for PV with the Competent Authority, including 24/7 availability as legally required.
    • Interface Management: Liaise between the EU-QPPV/Global PV team and local regulatory authorities.
    • Local PV System Management: Set up and manage the local pharmacovigilance system.
    • Literature Search: Conduct local literature searches for safety-relevant information.
    • ICSR Management: Oversee local Individual Case Safety Report (ICSR) management.
    • PV Intelligence Screening: Screen for relevant PV intelligence.
    • PSMF Maintenance: Maintain the local Pharmacovigilance System Master File (PSMF).
    • Data Collection: Organize local data collection efforts.
    • PVA Management: Manage local Pharmacovigilance Activities (PVA).
    • Regulatory Submissions: Adapt and submit PSURs (Periodic Safety Update Reports) and Risk Management Plans (RMPs) locally.
    • Signal Detection: Conduct local signal detection activities.
    • Risk Minimization: Implement additional risk minimization measures as necessary.
    • Medical Information Support: Provide integrated first-level medical information and Product Quality Complaints (PQC) support.
    • Audit Participation: Participate in PV-relevant audits and inspections.
    • Meeting Attendance: Attend regular project meetings as scheduled.
    • Monthly Reporting: Provide monthly reports on the status of the local PV system.
    • Training: 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 profound knowledge in pharmacovigilance.
    • Knowledge: Expertise in global and local legislative guidelines related to pharmacovigilance, along with a detailed understanding of relevant SOPs.
    • Training: Participation in relevant training courses, both internal and external.
    • Operational Experience: Familiarity with all operative tasks within the pharmacovigilance department.
    • Organizational Skills: Ability to organize operational procedures and manage multiple tasks simultaneously.
    • Adaptability: Capability to quickly adjust to new and challenging situations.
    • Problem Solving: Strong analytical skills to identify and develop solutions to problems.
    • Work Ethic: Autonomous, detail-oriented, and committed to high-quality work.
    • Team Player: Ability to work collaboratively within a team.
    • Language Skills: Proficiency in Slovak or Czech is essential, along with a very good command of English.

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

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