Alexander Popkov

Leading management of deviations, CAPAs, change controls, and PV risks assessment

Monitoring KPIs and conducting regular process reviews of the PV process

Ensuring timely implementation and closure of CAPAs

Ensuring alignment of local SOPs with global standards, GxP requirements, and regulatory updates

Managing SOP life cycle, including creation, periodic review, approval, and archiving

Coordinating SOP training and ensuring full compliance and documentation of training completion

Maintaining adequate documentation of the PV processes

Ensuring appropriate resources for back-up activities in PV

Creating and periodically checking business continuity plans for the PV system

Managing local PV vendor oversight, including qualification, performance review, and documentation control

Generating routine and ad-hoc PV metrics reports for local and global management

Identifying process gaps and implementing continuous improvement initiatives

Managing Safety Data Exchange Agreements and ensuring timely reconciliation of safety data

Designing and delivering onboarding, ad-hoc, and annual PV trainings for internal teams and third parties

Monitoring product safety data to identify potential signals

Evaluating and maintaining the risk–benefit profile of company products

Developing and implementing RMPs and aRMMs

Assessing the effectiveness of aRMMs

Ensuring timely submission of signals and RMPs to HAs

Planning, coordinating, and submitting Periodic Safety Reports in compliance with local and global requirements

Updating training materials and monitoring KPIs to ensure compliance and training effectiveness

Acting as QPPV back-up and maintaining oversight of local PV operations

Creating, updating, and controlling access to the PSMF

Interpreting and implementing GxP and PV legislation to ensure compliance with ongoing PV activities

Serving as the primary contact for the HAs and ensuring timely, accurate responses

Collaborating with Regulatory Affairs, Quality Assurance, Medical Affairs, and Clinical teams to ensure alignment on product safety and PV requirements

Providing PV input during local product launches, label updates, and lifecycle management activities

Reviewing local promotional and non-promotional materials from a PV perspective

Developing and maintaining PV agreements with distributors and vendors

Conducting training activities for third parties

Performing regular safety data reconciliations with third parties

Supporting vendor selection and qualification during the tender process

Establishing and managing a local PV system to ensure compliant case processing

Overseeing the collection, processing, quality check, submission, tracking, documentation, and archiving of safety information for case safety reports

Ensuring timely submission of local and foreign ICSRs to Health Authorities based on regulatory timelines

Complete restructure of case processing and quality control processes, increasing compliance rate to 100%

Reduced case processing turnaround time by 30% through workflow optimization and quality control tools implementation

Implemented new EAEU GVP and personal data protection regulations, ensuring full regulatory alignment and inspection readiness

Developed a process for creating and updating local RMPs and aRMMs, delivering 15+ RMPs and several aRMM distributions

Led 3 GxP/GVP audits with only minor findings and recommendations

Provided expert PV input in registration of 6 new medical products and harmonization of 15 products

Conducted search and selection of a new PV vendor, preventing critical risks and reducing maintenance costs by 30%

Improved cross-functional training with GxP and non-GxP departments at global and affiliate levels

Authored and maintained 15+ versions of local quality documents aligned with global standards and local GxP legislation

Managed work with 30+ PV vendors, commercial partners, and distributors

Established and managed a local PV system to ensure compliant case processing

Oversaw the collection, processing, quality check, submission, tracking, documentation, and archiving of safety information for case safety reports

Ensured timely submission of local and foreign ICSRs to Health Authorities based on regulatory timelines

Monitored case processing KPIs at the affiliate level to ensure high-quality performance

Managed deviations and CAPAs for all deviations at the local PV

Acted as a subject matter expert in case processing for Western Europe and Eurasia countries

Updated the ICSR submission format (E2B R3) and co-developed the ICSR gateway submission

Supervised the ARGUS update and educational process

Improved case-processing work between Novartis and global ICSR vendor through new SOPs, enhanced feedback, and more process control

Acted as a local PV compliance manager with full oversight of deviations and CAPAs

Co-developed an alternative educational platform (Novapedia) with the Global Data Science & Analytics team