Riti Singh

Background

About Riti Singh

Senior Leader with more than 20 years of combined and diverse experience in Pharmacovigilance, Medical Information, Quality, Regulatory, Medical Affairs, Ethics & Compliance. Proven record of leading business transformation, building departments from inception into successful, functional, compliant, engaged, and competitive high performing teams to meet business needs. Strategic thinker with strong ability to lead cross-functional teams and influence through matrix organization. Proven track record in establishing best practices at medical information and drug safety call centers. Experience in leading and conducting risk based post-marketing Medical and Pharmacovigilance Compliance Audits, GDP, GMP and Vendor Audits. Successfully developed and implemented medical strategy plans to support product launches (innovative brands, generics and branded generics). Strong ability to build relationships and engage with KOLs, patient organizations and advocacy groups. Led the development & execution of Scientific KOL Advisory boards at local affiliate level. Expertise in launching & managing CMEs programs with different healthcare accreditations. Successfully lead the medical strategy and KOL engagement to facilitate NAPRA approval for Rx to OTC Switch for various drug products. Key Areas of Expertise: End to End Pharmacovigilance Pharmacovigilance Operations, Compliance and GVP Inspections Quality GMP and ISO Audits and Vendor Management GxP System (QMS, DMS, LMS) Selection, Design, Validation & Implementation Regulatory License - DEL and MDEL Management Medical Information - Call Center Management Medical Affairs Strategy Planning Medical Compliance, Ethics and Governance in line with IMC External Medical and Scientific Communications Scientific Product training for field sales and commercial teams KOL Relationship Building and Advisory Boards