Pooja Yadav
Business Process Lead
Thane
Summary
Project Management Professional (PMP)-certified Pharmacovigilance professional with over 10 years of experience in global drug safety operations, including team leadership, case processing oversight and regulatory compliance. Proven expertise in managing end-to-end ICSR lifecycle, ensuring adherence to regulatory guidelines. Experienced in leading cross-functional teams, conducting onsite client training, and driving process improvements to enhance quality and operational efficiency. Strong background in stakeholder management, audit readiness, and performance optimization
Overview
14
14
years of professional experience
3
3
Certifications
3
3
Languages
Work History
Business Process Lead
TCS
Thane
03.2018 - Current
- Lead, mentor, and manage a team of PV associates/senior associates.
- Allocate workload and ensure adherence to timelines and quality metrics.
- Conduct performance evaluations and support career development.
- Provide training on safety database systems and regulatory updates.
- Oversee ICSR processing (serious/non-serious cases) from intake to submission.
- Ensure accurate medical coding (MedDRA, WHO-Drug).
- Review and approve cases for regulatory submission.
- Delivered onsite pharmacovigilance training to client teams and cross-functional stakeholders.
- Conducted classroom and hands-on training sessions on ICSR processing, MedDRA coding, regulatory timelines, and safety database usage (e.g., Argus).
- Led knowledge transfer (KT) sessions during project transitions and client migrations.
- Developed training materials, SOP guides, and process manuals.
- Evaluated trainee performance and ensured competency before independent case handling.
- Monitor compliance with global reporting timelines (FDA, EMA, PMDA, etc.).
- Ensure adherence to global pharmacovigilance regulations and company SOPs.
- Support audits and inspections (internal, client, regulatory).
- Address CAPAs and quality issues effectively.
- Drive continuous process improvement initiatives.
- Monitor KPIs and quality metrics.
- Implement best practices for operational efficiency.
Denial Specialist
Health Prime International
Mumbai
06.2012 - 03.2018
- Resolved medical claims by approving or denying documentation, calculating benefit due and initiating payment or composing denial letter.
- Maintained knowledge of insurance coverage benefit levels, eligibility systems and verification processes.
- Improved claim denial resolution by thoroughly researching and identifying root causes of denials.
- Examined medical treatment records and medical bills to gauge overall extent of liability.
- Served as a subject matter expert on denial-related issues within the organization, providing guidance and support to colleagues when needed.
- Trained new employees on denial management best practices, fostering a knowledgeable and efficient workforce.
- Conducted comprehensive audits for insurance claims, identifying discrepancies to prevent future denials.
- Analyzed trends in claim denials, advising management on potential areas for process improvement.
Education
Bachelor of Science - Chemistry
Mithibai College
Mumbai, India 04.2001 -
Skills
Operational excellence
Workflow optimization
Performance metrics development
Team building and motivation
Cross-functional team leadership
Teamwork and collaboration
Effective communication
Audit reporting
Active listening
Business continuity planning
Resource allocation
Regulatory compliance
Certification
Certified Project Management Professional
Timeline
Business Process Lead
TCS
03.2018 - Current
Denial Specialist
Health Prime International
06.2012 - 03.2018
Bachelor of Science - Chemistry
Mithibai College
04.2001 -