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Local Person For Pharmacovigilance (Lppv)

0-2 years
Not Disclosed
10 Dec. 30, 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

Local Person for Pharmacovigilance (LPPV) - Poland (Remote)
Pharmalex

Are you seeking a dynamic career with daily new challenges and opportunities? Look no further! Pharmalex, a leading global service provider in the pharmaceutical industry, is specialized in all aspects of drug and medical device approvals, market development, and product maintenance. We are currently hiring a Local Person for Pharmacovigilance (LPPV) in Poland to manage and maintain the local pharmacovigilance system and oversee local Pharmacovigilance (PV) operations.

Your Role

As the Local Person for Pharmacovigilance, you will:

  • Act as the primary point of contact for PV with the Competent Authority in the territory, ensuring 24/7 availability if legally required.
  • Interface between the EU-QPPV/Global PV team and local regulatory authorities.
  • Establish and manage the local pharmacovigilance system.
  • Conduct local literature searches and manage ICSR (Individual Case Safety Reports).
  • Perform PV intelligence screening, maintain local PSMF (Pharmacovigilance System Master File), and manage organized data collection.
  • Manage local PVAs (Pharmacovigilance Agreements) and local adaptation and submission of PSUR/RMP (Periodic Safety Update Reports/Risk Management Plans).
  • Participate in signal detection and implement additional risk minimization measures.
  • Review materials related to local post-authorization safety.
  • Provide first-level Medical Information and PQC (Product Quality Complaints) support.
  • Participate in PV-related audits and inspections.
  • Attend regular project meetings and provide monthly PV reports on the status of local PV systems.
  • Ensure PV training for affiliate employees, service providers, and third parties.

Your Profile

  • University degree in Medicine, Pharmacy, or Life Science.
  • Several years of experience and in-depth knowledge of pharmacovigilance practices.
  • Expertise in global and local pharmacovigilance guidelines, SOPs, and industry principles.
  • Experience in all operative tasks performed by the pharmacovigilance department.
  • Ability to organize operational procedures and manage multiple tasks simultaneously.
  • Capacity to adapt quickly to new challenges and analyze problems effectively.
  • Autonomous, focused, and committed to delivering high-quality work.
  • Strong teamwork skills and a sense of responsibility.
  • Proficiency in Polish is required, along with a very good command of English.

This is a remote position for candidates based in Poland with proven experience in local pharmacovigilance.

Application Instructions

If you are interested in this exciting opportunity with Pharmalex, please submit your application, including your earliest possible start date, visa requirements, and salary expectations. For more information, feel free to contact us directly.

Agencies may only apply with prior agreement for specific job opportunities.