Senior Pharmacovigilance Compliance Officer Pharmacovigilance
4 tygodni temu
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 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
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 a post-marketing setting and to be part of a progressive department
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