Dedicated and experienced pharmacovigilance professional with strong background in drug safety and regulatory compliance. Proven track record of leading successful pharmacovigilance delivery projects and ensuring adherence to industry standards and guidelines. Skilled in managing teams fostering client relationship and driving process improvements to optimize delivery operations.
Managed ~250 FTE team of PV professionals delivering Global ICSR activities for a large Pharma company including Case Intake, Case processing, medical review, Quality review, EMA Submission, Study reconciliation, GPS MAP, PV Partnering support, Regulatory reporting services and other ancillary ICSR support activities.
I hereby declare that the above-mentioned information is true to my best knowledge.