Associate Director Pharmacovigilance Life-Cycle Management Quality
• Ensured compliance with GVP and GCP regulations for and US FDA EMA, MHRA through regulatory intelligence review and impact assessment.• Lead FDA and ensured inspection preparedness which included performing Mock Inspection interviews and coordinating practice inspections sessions Assessed inspection readiness according to the FDA BIMO PADE inspection manual.• Member of the CAPA Compliance Counsel reviewing audit, deviation, and inspection CAPA for timely completion and effectiveness• Lead / Conducted global process audits such as compliance of new global safety database and ICSR case processing, Risk Management Plans, and US FDA REMS Operations, Investigator Brochure• Acted as the subject matter expert concerning FDA drug safety regulation across all stages of drug development to ensure compliance and achieve business goals.Updated and renewed risk-based analysis tools for GVP operations and co development partners licensing partners.• Participate in due diligence assessments/qualifications of potential new vendors/partners.• Develop, deliver and support training sessions on US FDA regulation for internal and external stakeholders.
