• Support the PV audit service by performing PV audits as Co- or Lead-Auditor, PV SOP/GAP analyses, and audit/inspection readiness training;
• Support PV system set-up and maintenance, incl. provision of local responsible person for PV (LPPV) and/or EU-QPPV or respective deputy positions;
• Prepare and review PV quality management documents (e.g. SOPs, WIs);
• Create, implement and maintain Pharmacovigilance Agreements (PVAs) and System Master Files (PSMFs);
• Project management in the field of PV;
• Conduct initial and periodic PV training for the team and key clients;
• Higher Degree in medical, natural sciences or pharmacy or other life-science-related fields;
• Ideally, 5 years of relevant previous experience and profound knowledge regarding relevant legislative and non-legislative guidelines on pharmacovigilance;
• Knowledge of PV processes, the PV system, and QA/QM system structures;
• Ideally, knowledge of audit principles, procedures, and techniques;
• Previous experience in a PV service provider on different client projects or in a corporate PV department with exposure to relevant PV system management tasks (e.g. local safety officer/local QPPV, EU-QPPV or respective deputy positions of these) would be considered as a plus;
• English language fluency; German will be an advantage
• Proficiency in MS Office – with a strong focus on Excel, Outlook, and Word;
• Willingness to travel on business trips.
Arsis Global EOOD's Bulgarian recruitment agency license's (mediation in employment services) number is 2533 and was issued on 11.05.2018.
Note, that we will contact only those candidates who qualify for the position, in case you don't hear from us by 30th of June, this would mean that your application was unsuccessful in this occasion. Thank you for your application.