PharmExpert LLC - Baku, Azerbaijan

– Performs representative functions of the LPPV, including notification of local regulatory authorities (RA) on the nomination of LPPV. Also, including registration in the database of local RAs (if applicable)

– Interacts with the local RA on behalf of the MAH/Third party in the Territory

– Keeps both accounting and reconciliation with MAH/Third party on received and submitted to the RA cases of adverse reactions (AR).

– Performs continuous monitoring of the safety lines, including 24/7 availability of the LPPV for RA and receiving information from the MAH/Third party

– Informs the MAH/Third party on the safety information received through the safety data monitoring channels (e.g., literature and internet sources, ICSRs safety databases of local RA, project specific mailbox, etc.) within required timeframes

– Performs regulatory intelligence and monitoring of updates pertaining to pharmacovigilance in the Territory

– Performs and documents monitoring of local literature and Internet resources in the Territory on a weekly basis to search for safety information. Furthermore providing the results of local literature monitoring to the MAH/Third party

Oversight of Pharmacovigilance System: Qualified Person for Pharmacovigilance is responsible for ensuring that the pharmacovigilance system is maintained and operates within the legal and regulatory frameworks established by health authorities across different countries.

Adverse Event Reporting: The Qualified Person for Pharmacovigilance oversees the reporting of adverse drug reactions to the relevant health authorities. This involves thorough monitoring, evaluation, and documentation of all cases of ADRs.

Risk Assessment and Management: The QPPV/Local QPPV is involved in the assessment of risks associated with drugs throughout their lifecycle, from development through post-marketing. This includes evaluating new safety information and deciding whether further risk mitigation strategies are required.

Communication with Regulatory Authorities: One of the core duties of the Qualified Person for Pharmacovigilance is to maintain open lines of communication with regulatory bodies. They provide updates on the safety profiles of products and ensure compliance with the requirements for reporting and communication of safety data.

– Development and maintenance of Pharmacovigilance System Master File (PSMF)
– 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
– Safety communication
– Managing medical information requests obtained from Consumers/HCPs/Sales representatives
– Conducting post-authorization safety studies (PASS)