Qualified Person for Pharmacovigilance (QPPV)

Act as the primary and single point of contact to EMEA, and other national competent authorities, and on behalf of MAH communicate new and emerging safety concerns in a timely manner, and benefit risk assessment analysis to the competent authorities

Provide oversight of the MAH’s or client’s safety systems, processes and procedures

Ensure performance and maintenance of MAH’s pharmacovigilance Systems and risk management, and oversee pharmacovigilance audits to assess regulatory compliance

Provide required knowledge and expertise for interpreting and applying local and global safety regulations

Ensure all ICSRs collected, processed, and reported align with all applicable EU regulatory MAH obligations

Provide oversight of signal detection and risk management activities

Ensure timely submission, and quality of aggregated data reports (e.g. PSURs, Post authorization study reports, risk management findings) and other documents required by European Health Authorities

On behalf of the MAH, facilitate required QPPV meetings to exchange information with the appropriate regulatory authority on ongoing safety issues, regulatory safety issues, signals undergoing evaluation, case compliance metrics, and other aspects of the PV system and overall risk management

Ensure adequate quality assurance, control, performance, and measurement to include SOPs and work instructions to cover all processes relevant to Pharmacovigilance

Develop the pharmacovigilance Quality Audit schedule, per regulatory authority or other internal request, and implement corrective action per the audits recommendations.

Provide continuous oversight including audits of the MAH and Drug Safety Units (DSUs) to ensure compliance to both company standards, and EU regulatory standards

Ensure all personnel involved in the pharmacovigilance system receive adequate training on all aspects of an EU regulatory mandate affecting pharmacovigilance