Be a part of our growing company!
Are you eager to work in a dynamic company where new challenges and opportunities are part of your everyday life? Then make PharmaLex your career choice! PharmaLex is the leading service provider for the worldwide pharmaceutical industry in regulatory affairs, pharmacovigilance, and development consulting. We specialize in effectively designing all aspects of drug and medicinal product registrations – ranging from early development and market entry to product maintenance activities. The success of our company resides in the expert knowledge and high motivation of our employees.
We are looking for motivated, committed candidates who will enjoy working independently within our successful team in a challenging environment. So, if your career is much more than just a job for you but rather your passion, then come and join our successful team. In Sofia, we are looking for a Manager Pharmacovigilance.
The purpose of the position is to provide strategic support in pharmacovigilance (PV) system activities and work in PV projects as requested by the client.
- 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;
- Represent the department and the company towards different authorities, associations and other organizations. Build, develop, and maintain working relationships with clients.
- Higher Degree in medical, natural sciences or pharmacy or other life-science-related fields;
- Ideally, 4 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;
- Proficiency in MS Office – with a strong focus on Excel, Outlook, and Word;
- Ability to adjust rapidly to new, unknown, challenging situations;
- Willingness to travel on business trips.
- 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.
If you are interested to take up the challenge at our future-oriented company and would like to grow together with us, apply by sending your CV and Cover Letter (optional). We appreciate all applications but will be able to contact only the short-listed candidates.
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
Agencies only by prior agreement for the specific job opportunity.