Specialist Pharmacovigilance

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 Plovdiv we are looking for a:

Specialist Pharmacovigilance

Main responsibilities:

► 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);

Requirements:

► Successful completion of a Master Degree in medical, natural sciences or pharmacy;
► 1 year of experience and profound knowledge regarding relevant legislative and non-legislative guidelines on pharmacovigilance;
► Ideally experience in personnel management;
► 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;
► English language fluency;
► Proficiency in MS Office – with strong focus on Excel, Outlook and Word.

What we offer:

► Opportunity to conquier exciting and varied challenges alongside a talented team;
► Option for flexible working hours;
► Open and collaborative organisational culture with emphasis on knowledge-sharing;
► Business interaction with nearly all branches of the company across 5 continents;
► 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) via Jobs.bg - https://www.jobs.bg/job/4676355