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:
Pharmacovigilance Senior Manager
- 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
- 4 years of relevant previous experience and profound knowledge regarding relevant legislative and non-legislative guidelines on pharmacovigilance;
- Ability to organize operational procedures and manage different tasks at the same time (e.g. effective coordination of personnel resources for time-conflicting projects);
- English language fluency;
- 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 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. We appreciate all applications but will be able to contact only the short-listed candidates. Thank you!
Agencies only by prior agreement for the specific job opportunity.