Debapriyo Koley
Group Lead- Medical Safety Operations @Novartis
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WORK HISTORY
Group Lead- Medical Safety Operations @Novartis
Hyderabad, IN
Manage a group of Medical Safety Experts within the Medical Safety Expert Office. Ensure that their deliverables are met according to the agreed standards and timelines.• Ensure quality & compliance in Medical Safety activities and drive compliance and quality to consistently high standards.• Participate in the Medical Safety Experts Office management strategy and operational plan.• Support the Head of the Medical Safety Expert Office in soliciting and forecasting future requirements for the Medical Safety Experts office.• Participate in organizing and planning the work of the Medical Safety Experts as per Therapeutic area aggregate reports and other documents schedule and ad-hoc urgent activities.• Is responsible for overall training and career development planning for the Medical Safety Experts group.• Liaise, support and represent the Medical Safety Experts Office during Audits and Inspections undertaken at CMO & Patient Safety• Build a high performing group of Medical Safety Experts and recruit, retain and develop best talent; assess resource needs on a regular basis to achieve ongoing process improvements.• Keeps an oversight of all outsourced activities related to medical function. • Work in collaboration with the training circle for any significant gaps and training needs for the vendor physicians. Also support onboarding and training activities within Medical Safety.• Represents Medical Safety in cross-functional and/or cross-departmental initiatives which aim to improve processes and ensure a quality and compliance. • Works with the Head of Medical Operations Excellence to identify and address potential quality issues and emerging compliance concerns.• Provides backup support for the Head of Medical Operations Excellence.Additional Responsibilities as Merger & Acquisition (M&A) Transition Project Manager• Leads assigned transition projects in CMO & PS, which are of high priority/criticality to the business.
EDUCATION
Sri Jayadev College of Pharmaceutical sciences, Biju Patnaik University of Technology
B. Pharma, Pharmacy
Institute of Clinical Research India, Cranfield University, UK
M.Sc, Clinical Research
SKILLS
ABOUT DEBAPRIYO KOLEY
Overall 16+ years of work experience in Pharmacovigilance (PV) including 11 years front line people management and leading global team.• 4 years of work experience in managing client accounts for end to end PV services (including ICSR, PSUR, Literature search, signal detection, label update, audit & Inspection).• 5+ years of work experience in core PV Operations including strategies and implementation of PV outsourcing (RFP, Global contracts, Budget, Governance, Transitions, Projects, Compliance, Productivity and Resources).• 2+ years of experience in Medical Safety Operations. In my current role, o I am mainly responsible to lead, direct and control a team of Medical Safety Experts, responsible for Medical Safety activities.o Successfully managed 7 Merger & Acquisition (M&A) project as business lead – timely integrated other companies safety system into Novartis• Certified Lean-Six Sigma Green belt• Certified PMP from \"Project Management Institute (PMI)\"• Winner of GDD Star Award at Novartis for driving simplicity
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