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11.06.2020
★★★ Senior Specialist / Junior Manager Pharmacovigilance, PharmaLex Bulgaria JSC  Вижте визитка на компанията
Месторабота София, ул. Юнак 11-13 (виж карта); Постоянна работа; Пълно работно време
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Senior Specialist / Junior Manager 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 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 Senior Specialist / Junior Manager Pharmacovigilance with the main purpose to provide client support in all pharmacovigilance (PV) activities or work in PV projects as requested by the clients.

Main responsibilities:

► Perform Local PV activities (local literature search, case processing, translations);

► Support PV system set-up and maintenance;

► Prepare and review QA documents such as Working Instructions, SOPs, Working Procedures, Templates, etc.;

► Participate in different Project management within the filed of PV;

► Support the PV service coordination by:

• Creating Proposals and RfP's;

• Preparing and reviewing MSA/WO/WP (contract management);

• Setting-up and provide maintenance support for partners/consultants in PLx systems;

• Supporting identification of new partners;

• Assisting in vendor/partner qualification/ re-qualification.

► Assist in establishing and maintaining Pharmacovigilance System Master Files (PSMF) and Risk Management Plans (RMP);

► Preform global and local literature reviews and provide medical review and information (if applicable);

Requirements:

► B.Sc. or M.Sc. Degree in medicine, natural sciences or pharmacy;

► At least one year of experience in pharmacovigilance and related aspects;

► Detailed knowledge of the applicable legislation (e.g. GVP, AMG)
► C1 level of English both written and spoken;

► Ideally, a good command German language;

► Proficiency in MS Office – with a strong focus on Excel, Outlook, and Word.

What we offer:

► Opportunity to conquer exciting and varied challenges alongside a talented team;

► Option for flexible working hours;

► Open and collaborative organizational 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 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. Thank you!


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