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Local Person For Pharmacovigilance (Lppv)

0-3 years
Not Disclosed
10 Oct. 24, 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

Grow with Us!
Are you looking for a dynamic company that offers daily challenges and opportunities? Look no further—Pharmalex is your next career move! Now part of Cencora, Pharmalex is a leading service provider in the pharmaceutical industry globally, specializing in all aspects of drug and medical device approvals, market development, and effective product maintenance.

Position: Local Person for Pharmacovigilance (LPPV)

This is a remote position for candidates already based in the Czech Republic with proven experience in local pharmacovigilance activities.

Your Role

  • Primary Contact:
    Act as the main point of contact for Pharmacovigilance (PV) with the Competent Authority in the territory, ensuring 24/7 availability if legally required.

  • Interface Management:
    Serve as the liaison between the EU-QPPV/Global PV team and local regulatory authorities.

  • Local PV System Management:
    Establish and manage the local pharmacovigilance system, including literature searches, ICSR management, and PV intelligence screening.

  • PSMF and Data Collection:
    Maintain the local Pharmacovigilance System Master File (PSMF) and organize local data collection.

  • Signal Detection and Reporting:
    Conduct local signal detection, adapt and submit PSURs and RMPs, and implement additional risk minimization measures.

  • Review and Support:
    Review materials related to post-authorization safety and provide integrated first-level medical information and PQC support.

  • Audit Participation:
    Participate in PV-related audits and inspections and attend regular project meetings.

  • 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.

  • Regulatory Knowledge:
    Familiarity with relevant global and local legislative guidelines and detailed knowledge of SOPs.

  • Operational Expertise:
    Experience in all operational tasks performed by the pharmacovigilance department.

  • Organizational Skills:
    Ability to manage multiple tasks simultaneously and effectively coordinate personnel resources.

  • Adaptability:
    Capable of adjusting rapidly to new and challenging situations.

  • Problem-Solving Skills:
    Strong analytical abilities to identify and solve problems.

  • Team Player:
    Autonomous, concentrated, and capable of high-quality work, with a strong sense of responsibility.

  • Language Skills:
    Proficiency in either Slovak or Czech is required, along with a very good command of English.

How to Apply

If you are interested in joining the Pharmalex team for this exciting opportunity, please submit your application, including your earliest possible starting date, any visa requirements, and salary expectations. We look forward to hearing from you!

Note: Agencies should contact us only with prior agreement regarding this specific job opportunity.