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 every day 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
Senior Specialist Pharmacovigilance with German
- Assist in establishing and maintaining Pharmacovigilance System Master Files (PSMF) and Risk Management Plans (RMP);
- Provide active support in managing ICSRs / SUSARs, creating and maintaining XEVMPD drug list;
- Support establishing and updating Periodic Safety Update Reports (PSUR) / Development Safety Update Report (DSUR) and Signal detection and analysis;
- Assist in consulting clients on Company Core Safety Information (CCSI) as well on Reference Safety Documents like CCDS, SPC, PIL;
- Preform global and local literature reviews and provide medical review and information (if applicable);
- Successful completion of a Master Degree in medical, natural sciences or pharmacy;
- 2 year of experience and 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);
- Previous experience in regulatory affairs would be an advantage;
- 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;
- Option for flexible working hours;
- Open and collaborative organisational culture with an emphasis on knowledge-sharing;
- 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.