Pharmacovigilance Services

1. Ensuring QPPV, Deputy QPPV, and a physically responsible person with a medical education / doctor
2. 24-hours contact details for QPPV and deputy QPPV;
3. Provision of QPPV for initial registration of medicinal products (for Bulgaria) and related pharmacovigilance services for the needs of the MAH to comply with EU regulatory requirements (Regulation 1235/2010 and Directive 2010/84 / EC) and local obligations to designate a local pharmacovigilance contact point for each registered product;
4. Development and implementation of a comprehensive pharmacovigilance system (PSMF, SOPs, WI, diaries);
5. EudraVigilance database registration services (reporting to ICSR / SUSAR, XEVMPD - electronic drug information, XEVMPD support);
6. Collecting, processing and evaluating ICSRs (Case Reports) as well as reporting serious ADR (adverse drug reaction) in EudraVigilance;
7. Weekly local and global (through PubMed) literary search, MLM weekly search and subsequent evaluation of relevant articles / scientific statements. Medical review of adverse events from incidents, incl. writing a Report on Assessment of Literature, identifying important signals about the safety profile of medicinal products and undertaking follow-up;
8. Pharmaceutical training for all employees in your company, including issuing a certificate;
9. Making of audits, participation in the preparation of drug safety inspectorates by the BDA or other internal audits;
10. Creating, tracking and performing all Signal detections;
11. Identification and development of Risk Management Plans (RMPs);
12. Preparation of Periodic Safety Reports (PSURs) - and PSUSA repository