GVP Auditor 17

Profile: An ardent Pharmacovigilance and Quality Assurance Professional with Master of Science in Regulatory Affairs as well as Pharmacology | A Certified Biomedical Auditor (ASQ) | A Trained ISO 9001 Lead Auditor (BSI) | An experienced PV and QA leader with more than a decade of experience in managing Drug Safety & Quality Assurance activities. Skills and Expertise include Pharmacovigilance Auditing – Internal, Systems, Partner and Service Provider Audits. Quality System Auditing. Risk-based Pharmacovigilance/Quality System Audit Planning – Strategic (long-term) planning/scheduling, Tactical (annual) planning/scheduling, Operational planning. CAPA Review, Analysis and Management. Successful management of PV related Inspections from Regulatory Authorities. Vendor Management, Oversight and Support. Coaching and Employee training. Development of Training Materials/Modules. Case Processing, Adverse Event Reporting and End-to-End process-monitoring. Medical Information and Product Complaints management. Preparation aggregate reports, such as PADER and PSUR. Risk Management Activities under FDA and Health Canada regulations: Experienced in managing multiple REMS/RMPs. Safety-Data migration across the companies upon change in Marketing Authorization. Due diligence of Pharmacovigilance processes. Development and Review of Periodic Metrics and Compliance Reports for PV activities. Development of Safety Data Exchange Agreements (i.e., Pharmacovigilance Agreements) with Business Partners and Service Providers. Document control and related QMS activities (e.g., Authoring and Reviewing SOPs, Change Controls, etc.). Firm knowledge of Regulations prevailing in North America, Japan and EMEA with an experience in supporting QPPV Obligations in Europe, including PSMF support. Project, Support, Coordination and Management per Lean Six Sigma Principles. Qualification of Service Providers for GxP Activities. Languages known: English and Hindi. Based in Canada.