Job title: Manager Pharmacovigilance S
Job type: Permanent
Emp type: Full-time
Location: Sofia, Bulgaria
Job published: 2020-10-13
Job ID: 32201

Job Description


Manager Pharmacovigilance

Sofia, Bulgaria


- 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;

- Higher Degree in medical, natural sciences or pharmacy or other life-science-related fields;

- 3 years of relevant previous experience

- Knowledge of PV processes, the PV system, and QA/QM system structures;

- 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;

- Willing to travel on business trips

- Fluent in English language;

- Opportunity to conquer exciting and varied challenges alongside a talented team;

- Business interaction with nearly all branches of the company across 5 continents;

- A broad range of initiatives for personal development and professional training.

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 25th of November, this would mean that your application was unsuccessful in this occasion. Thank you for your application.