We are growing, grow with us!
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.
Senior Specialist / Junior Manager
- 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)
- 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
- 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