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Local Person For Pharmacovigilance (Lppv)

2-3 years
Not Disclosed
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

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We’re Growing—Grow With Us!
Are you ready to embrace new challenges in a dynamic environment? Look no further!

PharmaLex, now part of Cencora, is a global leader in pharmaceutical consulting services. We specialize in drug and medical device approvals, market development, and end-to-end product lifecycle management.

We are currently seeking a Local Person for Pharmacovigilance (LPPV) based in the Czech Republic. 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 (Czech Republic)
Experience Required: Proven expertise in local pharmacovigilance activities


Your Responsibilities

  • Serve as the primary pharmacovigilance contact for the Competent Authority in the territory, including 24/7 availability if required by law.
  • Act as a liaison between the EU-QPPV/Global PV team and the local regulatory authority.
  • Establish and manage the local pharmacovigilance system.
  • Perform local literature searches and Individual Case Safety Report (ICSR) management.
  • Conduct 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).
  • Implement additional risk minimization measures and conduct local signal detection.
  • Review materials related to local post-authorization safety.
  • Provide integrated first-level medical information and Product Quality Complaint (PQC) support.
  • Participate in PV-relevant audits and inspections.
  • Submit monthly PV status reports for 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 hands-on experience in pharmacovigilance with detailed knowledge of global and local PV guidelines.
  • Skills:
    • Expertise in pharmacovigilance operations and compliance with legislative frameworks.
    • Familiarity with Standard Operating Procedures (SOPs) and industry principles of pharmacovigilance.
    • Strong organizational skills to manage multiple tasks and coordinate resources effectively.
    • Analytical and problem-solving capabilities with a proactive approach.
    • Excellent communication skills and a team-oriented mindset.
  • Languages: Proficiency in Slovak or Czech is mandatory, along with a strong command of English.

What We Offer

  • An opportunity to join a global leader in pharmaceutical consulting.
  • Work in a collaborative, forward-thinking environment with a focus on innovation and excellence.
  • Flexible remote working arrangement tailored for professionals in the Czech Republic.

If you’re ready to take on this exciting challenge, submit your application online, including your earliest possible start date, visa requirements (if applicable), and salary expectations.

Contact Us:
For more details about the role, feel free to reach out.

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


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