Senior Pharmacovigilance Compliance Officer
Senior Pharmacovigilance Compliance Officer
Posted on :
11-03-2025
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1 Vacancy
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Job Description
Job Purpose
Monitoring PV compliance indicators coordinate 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 thirdparty vendors comply with PV requirements;
- Organising and hosting PV inspections/ audits of external bodies e.g. Health
Authorities and partner companies globally - Prepare for andand 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 ongoing enhancement of the Theramex PV processes andwriting Standard Operating Procedures and Working practices
MinimumRequirements(Experience &Education)
- The candidate will be a life science graduate and have relevant drug safety
experience 23 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 selforganized narrative writing and impeccable attention todetail 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 postmarketing setting and to be part of aprogressive department
Employment Type
Full Time
Key Skills
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