Hema Bajaj
Head of Clinical Quality and Medical Excellence
Sanofi
54, rue La Boétie, 75008 Paris, France
http://en.sanofi.com/index.aspx
· Senior professional with 11 plus years’ experience in Medical Quality and Marketing Compliance spreading across Promotional Ethics and Compliance, Product Quality, Drug safety, and Quality processes.
· Currently heading affiliate quality systems for Sanofi India Pharma and lead Clinical Quality and Marketing Compliance for Sanofi, India for 9 years.
· Have been instrumental in setting up novel electronic Transparency Platforms and implementing Quality/Compliance Systems at Sanofi India, in accordance with Sanofi Global Quality Policies, Quality Directives, Standards, International and local regulatory requirements.
· Areas of expertise include Quality Management, Project Management, Quality Assurance, Pharmacovigilance, Ethical Compliance, Business Excellence, Learning and Development.
HIGHLIGHTS of EXPERIENCE
· Marketing Ethics and Compliance: ensure compliance with industry standards like MCI rules, DoP, IFPMA, OPPI guidelines for ethical promotion, ethical interaction with healthcare professionals, medical institutions, patient organizations and implementation of transparency policy across all Sanofi Franchise (Pharma, Pasteur, Genzyme and Shantha Biothenics).
· Organizational Quality Management for Pharmacovigilance and other departments: Ensure Quality organization and management of Quality Documents to support Quality and Compliance Program for Pharmacovigilance, Medical Affairs Quality, and other departments.
· Project management: participate and lead team for business critical projects from start-ups to implementation for affiliate and region.
· Quality Management: Ensure Quality audits/ checks are conducted and hosted – internal and external customer audits, and inspections including company audits, system audits, process audits, site audits, and certification audits (e.g.; ISO certification, etc.)
· Training and tracking: ensure training of PV, Quality and Medical on company standards, and external stakeholders (KOLs, investigator teams, ethic committee members, etc.) across hospitals and institutions, on industry standards and regulations.
· Data analysis and reporting: Perform quality assurance consulting projects, data analysis and reporting for process improvements, product quality, PTCs.
· Team Management and Development: training and mentoring Pharmacovigilance and Quality, Medical Affairs team members; planning, assigning, and directing work; appraising performance and guiding professional development.
