Senior Pharmacovigilance Compliance Officer

5 dni temu


Warszawa, Mazovia, Polska Theramex Germany GmbH Pełny etat
Senior Pharmacovigilance Compliance Officer

2 days ago Be among the first 25 applicants

Job Purpose
Monitoring PV compliance indicators, co-ordinate and manage PV audits and inspections; Performing an accurate and scientifically sound data entry in the Theramex Global Safety database.

Key Duties And Responsibilities

  • Monitoring the 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/ inspections 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 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 on-going enhancement of the Theramex PV processes and writing Standard Operating Procedures and Working practices

Minimum Requirements (Experience & Education)

  • The candidate will be a life science graduate and have relevant drug safety experience (2-3 years)
  • 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
  • This is an excellent opportunity for a candidate seeking to develop / broaden their safety knowledge in post-marketing setting and to be part of a progressive department

We are Theramex, a global specialty pharmaceutical company solely committed to supporting the health needs of women through every stage of life.

We work closely with our partners, healthcare professionals, and patients to help women find the solution that may be right for them at the time they most need it.

Seniority level
  • Mid-Senior level
Employment type
  • Full-time
Job function
  • Legal
  • Industries
  • Pharmaceutical Manufacturing
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