Pharmacovigilance specialist / Специалист по фармаконадзору (фармакобезопасности)

01 Октября

Партнерские Вакансии

Компания "ManpowerGroup"

ManpowerGroup in Russia and the CIS and our client, an American pharmaceutical company, are looking for a pharmacovigilance specialist.

Key responsibilities:

• ensuring Individual Case Safety Report (ICSR) case processing and related activities are carried out to enable compliance with applicable regulatory requirements, company procedures, at a local/regional level or global level, and in compliance with provisions of PV agreements with business partners;
• continual monitoring, assessing the reportability of ICSRs due for regulatory reporting, and submitting to respective Competent Authorities, as applicable;
• proper storage and archive of Case processing related documentation;
• Health Authority database monitoring for detection of the new reported cases;
• reconciliation with other departments and partners (distributors, third parties, vendors, Health Authorities, and internal stakeholders).

Requirements:

• education: health care science professional e.g.: (nurse, pharmacist, life science degree) or equivalent training and experience. Higher pharmaceutical or medical education is preferred;
• 1-2 years of relevant experience;
• pharmaceutical industry experience; product vigilance responsibility role is preferred;
• knowledge and understanding of key legislation applicable to pharmacovigilance within Russia & CIS, as well as Eurasian Economic Union (EAEU) GVP;
• sound knowledge of medical terminology;
• fluency in English language;
• good verbal and written communication skills;
• ability to prioritize and work to strict timelines daily;
• ability to establish and maintain open relationships within the organization and with authorities;
• computer literate.

Working conditions:

• Manpower outsorce - renewable fixed-term contract;
• insurance, compensation for meals and mobile calls;
• working time: 5/2 since 9.00 a.m. to 18.00 p.m., hybrid (3 days in the office; 2 days remotely);
• location: business center Krylatskiy Hills.