Job Title:Pharmacovigilance Expert
Location:Sofia, Bulgaria
Job Type:Full time
Reporting to:General Manager
Main Purpose of Job:To assist the Pharmacovigilance team in providing PV and safety functions to client companies concerning medicinal products in human medicine.
Main Duties &         Responsibilities: – Management of safety and efficacy complaints;
– Reporting ICSRs to European Medicines Agency and Competent Authorities;
– development and submission of Periodic Safety Update Reports (PSURs);
– development of Riks Management Plans (RMPs);
– product information updates;
– translations of PV related materials and documents from English to Bulgarian language and vice versa;
– SOP updates.
Other Responsibilities:Duties will be variable depending on the nature of the undertaken projects (e.g. management of local PV contact points in the Member States). These will mainly fall within the areas of pharmacovigilance for pharmaceuticals for human use. Staying up to date with the changing PV requirements and regulatory framework is expected.
Skills/Experience: – preferably Master’s degree in Medicine or Pharmacy (MSc); Life sciences degree (BSc or equivalent) also acceptable;
– experience in PV is required, plus other relevant experience in other areas of the pharmaceutical sector is preferable;
– regulatory experience/knowledge would be beneficial;
– excellent learning abilities: promptly achieving/updating working knowledge of EU and national regulatory requirements and procedures is required;
– candidates must be familiar with MS Office;
– excellent written and oral communication skills in English are required, attention to detail and multitasking ability to follow-up projects, monitor and stay within deadlines is a distinct advantage.
Benefits:Dynamic small team and friendly environment. Salary negotiable and commensurate with experience. Trainings provided at national and international level.
Closing Date:Not set. Please send all applications with CV and cover letter to our office e-mail. All applications will be treated confidentially and in compliance with the applicable personal data protection requirements. Prospective candidates will be contacted when vacancies are available.

 

Job Title:Regulatory Affairs Officer
NOTE – no recruitment agency approaches please.
Location:Sofia, Bulgaria
Job Type:Full time
Reporting to:General Manager
Main Purpose of Job:To assist the Regulatory Affairs team, perform regulatory functions (medicinal products, medical devices, food supplements) and provide regulatory support on behalf of client companies.
Main Duties &         Responsibilities: – support submissions and follow-up procedures with the competent authorities (Ministry of Health, Bulgarian Drug Agency, National Council on Pricing and Reimbursement, Bulgarian Food Safety Agency);
– preparation of applications, notifications and supporting administrative modules;
– managing administrative procedures for medicinal products with the Bulgarian Drug Agency for obtaining MAs and for MAs maintenance;
– translation and editing of product information;
– communication with clients and competent authorities;
– keeping clients up to date with local national requirements.
Other Responsibilities:Duties will be variable depending on the nature of the projects to be undertaken. These will mainly fall within the areas of Regulatory Affairs for pharmaceuticals for human use. Staying up to date with changing regulatory requirements expected.
Skills/Experience: – preferably Pharmacist (MSc), Life sciences degree (BSc or equivalent) also acceptable;
– minimum 1 year experience in RA is required, plus other relevant experience in other areas of the pharmaceutical sector is preferable;
– pharmacovigilance experience/knowledge would be beneficial;
– excellent learning abilities: promptly achieving/updating working knowledge of EU and national regulatory requirements and procedures is required;
– candidates must be familiar with MS Office;
– excellent written and oral communication skills in English are required, attention to detail and multitasking ability to follow-up projects, monitor and stay within deadlines is a distinct advantage.
Benefits:Dynamic small team and friendly environment. Salary negotiable and commensurate with experience. Trainings provided at national and international level.
Closing Date:Not set. Please send all applications with CV and cover letter to our office e-mail. All applications will be treated confidentially and in compliance with the applicable personal data protection requirements. Prospective candidates will be contacted when vacancies are available.

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