Pharmacovigilance Lead

7 dni temu

Warszawa, Mazovia, Polska Theramex UK Pełny etat

Job Opportunity:

We are seeking a highly motivated and experienced Pharmacovigilance Compliance Officer to join our team at Theramex UK. As a key member of our PV department, you will be responsible for monitoring PV compliance indicators, coordinating and managing PV audits and inspections, and performing accurate data entry in the Theramex Global Safety database.

Key Responsibilities:

  • Monitoring PV compliance indicators for the performance of the Theramex Global PV team (ICSR, PSUR compliance, safety variations compliance, other compliance metrics)
  • Vendor Oversight – Ensure third-party vendors comply with PV requirements;
  • Organising and hosting PV inspections/audits of external bodies e.g. Health Authorities and partner companies globally
  • Prepare for and support internal and external audits in line with the Theramex audit schedule
  • Implementation and tracking of CAPAs (corrective and preventative action) plans for audits/inspections of Theramex; reviewing CAPA plans provided by Theramex audited organisations
  • Communicating audit/inspection findings with the relevant QPPV for the territories impacted
  • Tracking the compliance-related activities in Theramex eQMS system
  • Case processing including data entry, review, and assessment of AE/SAE reports
  • Performing AE/SAE reconciliation
  • Reviewing global and local literature sources
  • EudraVigilance activities including downloading ICSRs (Individual Case Safety Reports) from EudraVigilance and EudraVigilance submissions
  • Participating in the signal detection process for Theramex products
  • Contributing to the ongoing enhancement of the Theramex PV processes and writing Standard Operating Procedures and Working practices

Requirements:

  • The ideal candidate will be a life science graduate with 2-3 years of relevant drug safety experience
  • Competent with medical terminology, excellent communication abilities, and possess good IT skills
  • Advanced proficiency in English, with strong written and verbal communication skills
  • Previous use of safety databases and EudraVigilance is essential
  • Previous experience in compliance area is preferred
  • Work independently but also as part of a team
  • Understanding of GVP modules
  • A high standard of being self-organized, narrative writing, and impeccable attention to detail is essential
  • Availability to travel a few times per year

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