PharmExpert LLC - Baku, Azerbaijan

PharmExpert LLC provides pharmacovigilance services to its clients in line with a global, regional and local levels PV guidelines/Good Pharmacovigilance Practices (GVP). Marketing authorization holders/Pharmacovigilance providers may delegate following services to Us in the territory of CIS/EAEU countries-Azerbaijan, Belarus, Georgia, Russia, Kazakhstan, Kyrgyzstan, Tajikistan, Turkmenistan, Ukraine, Uzbekistan:
– Development and maintenance of Pharmacovigilance System Master File (PSMF)
– Appointment of QPPV (Qualified Person responsible for PV)/Local QPPV and QPPV/Local QPPV back-up
– Weekly literature monitoring of scientific-medical, non-medical sources, internet or digital media for safety information search at a local and global levels
– Weekly regulatory intelligence  

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monitoring of Health and Regulatory Authorities for safety information and regulatory updates at a local and global levels
– Collection, processing, evaluation, regulatory reporting, storage and archiving of Adverse Events (AE) and other safety related information from any sources
– Development of aggregate reports: Periodic Safety Update Reports (PSUR)/ Periodic Benefit-risk Evaluation Report (PBRER), Development Safety Update Report (DSUR)
– Development of Risk Management Plan (RMP)
– Assessment of the benefit-risk ratio of the MP
– Development and conduction of PV trainings
– Conduction of external audits
– Appointment of LPPV (Local Person for Pharmacovigilance) and LPPV back-up in the MP’s authorization countries
– Safety database maintenance
– Signal detection and management
– Safety communication
– Managing medical information requests obtained from Consumers/HCPs/Sales representatives
– Conducting post-authorization safety studies (PASS)
– Interaction with regulatory authorities on drug safety issues
– Pharmacovigilance consulting services on issues in the drug safety
– Obtaining, processing and reporting information on safety in PASS
– Outsourcing of entire Pharmacovigilance System.