1. Plans, conducts and document, internal and external GPvP audits to assess compliance with applicable regulations, regulatory commitments, company SOPs, protocols and contractual obligations as applicable.
2. Routine reviews of documentation include but are not limited to PV-plans, individual case processing, aggregate reports (e.g. PADER), REMS-related documents, safety database files and adverse event reports.
3. Audits and evaluates service providers (e.g. Drug Safety service providers, licensing partners, Specialty Pharmacies, etc.), as appropriate, to assess capabilities and compliance with applicable regulations, contractual obligations as well as with company policies and procedures.
4. Track, review, approve and assess the efficiency of Corrective and Preventive Action Plans (CAPAs) from audits and inspections
5. Prepares clear and concise written reports of audit observations, including an assessment of compliance.
6. Presents audit findings to senior management and, if appropriate, to the responsible individuals at service providers.
7. Evaluates responses and corrective and preventative action plans to audit findings for adequacy and timeliness, reviews implementation, and manages the closeout of all corrective and preventive actions.
8. Provides audit related metrics to Senior Management.