Manoj Kumar

Consulted and audited medical information and pharmacovigilance programs, including vendor qualification and PSMF management, while ensuring data privacy compliance and support for digital therapeutics solutions. Streamlined vendor management processes and designed pharmacovigilance auditing programs to strengthen compliance and reduce risk.

Planned, executed, and monitored CAR-T clinical trials while contributing to clinical study design, protocol/report compliance checks, and medical monitoring. Supported patient safety and data integrity, and helped manage relationships with alliance partners and CROs.

Oversaw medical information client delivery by aligning deliverables with service levels, KPIs, and consistent engagement. Led patient-safety process improvement initiatives, addressed client concerns, and strengthened staff performance and proficiency across client needs.

Directed medical information, pharmacovigilance, QMS, and compliance, including vendor due diligence, inspection readiness, and audit execution. Led ISO 13485 recertification and managed the ISMS for ISO 27001/27701 while serving as Data Protection Officer to ensure GDPR/PDPA/HIPAA compliance and 21 CFR Part 11 adherence.

Designed and implemented PV quality management systems, managed vendor qualification, and reviewed Pharmacovigilance System Master Files (PSMFs) to maintain regulatory compliance. Coordinated with engineering teams on QMS application configurations and delivered training and assessments to ensure competence in PV practices.

Supervised the medical component of local patient support programs, including clinical document reviews for regulatory authorities and collaboration with key opinion leaders (KOLs). Planned symposia and monitored vendor performance to ensure compliance with KPI and SLA expectations.

Managed medical services spanning medical information, pharmacovigilance, clinical operations, and medical affairs, including vendor due diligence, SOW management, and data privacy oversight. Led audits, monitored CAPA and audit closures, and prepared periodic safety update reports to support regulatory submissions.

Established pharmacovigilance quality management processes, reviewed clinical documentation for regulatory submissions, and managed safety data exchange agreements for affiliates. Supported risk-based inspections and audit readiness while driving continuous process improvements through quality assurance activities.

Managed PV services operations to meet SLA requirements, ensured compliance with regulatory and contractual expectations, and prepared for audit inspections. Reviewed periodic safety update reports and supported timely, compliant regulatory reporting.

Processed individual case safety reports across multiple therapeutic areas in a global pharmacovigilance and epidemiology workflow while ensuring strict SLA adherence for AEs and SAEs. Mentored new employees in data case management, completed required training modules, and maintained audit readiness.

Performed quality checks on patient health records to ensure accuracy and compliance, and served as a HIPAA compliance officer to strengthen data protection practices. Improved record quality through detailed reviews and implemented policies supporting privacy compliance.

Completed a Bachelor of Dental Surgery associated with Rajiv Gandhi University of Health Sciences (HKDET's Dental College).

Completed an Advanced Vaccinology course with Abbott Healthcare Pvt Limited.