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 are specialized 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 with German
The purpose of the position is organisational leadership and professional supervision of the pharmacovigilance team. You will also be responsible for implementing operational tasks in the field of pharmacovigilance.
- Participate in the evaluation of the benefit-risk profile, this includes the creation of safety update reports PSURs (Periodic Safety Update Reports), DSURs (Development Safety Update Reports), risk management plans and signal detection reports;
- Individual Case Safety Report (ICSR) assessment of adverse drug reactions deriving from clinical trials, spontaneous reporting systems, and the literature; decision on expedited reporting; reporting of ICSRs to the competent authorities;
- Active support in Creation and implementation and maintenance of Pharmacovigilance Agreements (PVAs) and System Master Files (PSMFs);
- Conduct initial and periodic PV training for the team and key clients;
- Economic and operational steering and supervision of the Pharmacovigilance department, while creating a motivational working environment;
- Representation of the company and the department towards clients, authorities, and associations. Build, develop and maintain working relationships with clients;
- Successful completion of a Master Degree in medical, natural sciences or pharmacy
- 3 years of relevant previous experience and profound knowledge regarding relevant legislative and non-legislative guidelines on pharmacovigilance;
- Ability to organise operational procedures and manage different tasks at the same time (e.g. effective coordination of personnel resources for time-conflicting projects);
- C1 level of English both written and spoken;
- B2/C1 level of German both written and spoken;
- Proficiency in MS Office – with a strong focus on Excel, Outlook, and Word.
- 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 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.
For further information please don’t hesitate to contact us:
Manager Human Resources
Agencies only by prior agreement for the specific job opportunity.