Gayatri Wadke-Honrao

• Proactively maintains, load and update state and manufacturer’s return goods policy with utmost accuracy to ensure Inmar’s policy database structure is kept current.
• Consistently maintains a detailed virtual documentation of all manufacturer/labeler’s policy, related communication and or requests, to include SalesForce cases.
• Completes weekly and monthly reporting based on client’s contractual agreement.
• When needed, provide support to the Account Manager in the way of reporting for client meetings, business reviews, contract negotiations, and or as a subject matter expert.

• Drove high-quality delivery of end-to-end Adverse Event case management activities in complex matrix environment, ensuring compliance with regulatory reporting requirements.
• Acted as primary contact for Vendor regarding Argus case processing inquiries.
• Monitored Key Performance Indicators (KPI) to ensure adherence to quality thresholds and submission timelines.
• Conducted quality checks of ICSR processed by Vendor in alignment with Good Vigilance Practice.
• Facilitated audits, inspections, and risk management activities related to post-market surveillance and complaint handling.

Drug Safety/ PV Process Trainer:

• Design and deliver comprehensive training programs on case processing, adverse event (AE) reporting, regulatory submissions, and Argus Safety.
• Conduct onboarding and refresher training sessions for PV associates.
• Develop and maintain training materials, SOPs, and work instructions, ensuring alignment with regulatory requirements.
• Coordinate with Quality and Compliance teams to identify gaps and implement CAPA-based retraining for audit findings.
• Monitor and evaluate trainee performance through tests, certification programs, and continuous learning initiatives.
• Prepare training reports to track compliance and training effectiveness.
• Support audit and inspection activities by ensuring all training documentation is current and inspection-ready.

Drug Safety/ PV Quality Associate:

• Perform quality control review of processed Individual Case Safety Reports (ICSRs) for compliance with global regulatory standards.
• Verify case accuracy, MedDRA coding, seriousness, causality, and regulatory reportability.
• Identify trends in recurring quality issues and provide feedback to case processors for corrective action.
• Support audit readiness by maintaining accurate QC documentation, training logs, and version-controlled SOPs.
• Participate in root cause analysis (RCA) and CAPA formulation for deviations or audit findings.
• Collaborate with Training teams to improve case processing standards and reduce QC rejections.

Drug Safety/PV Associate:

• Responsible for case processing of adverse event reports following company SOPs, internal business practices to ensure compliance with worldwide safety regulations and corporate policies.
• Adverse Event Case processing: completion of full case information on the Argus Safety database, including self-quality review to ensure accuracy and completeness.
• Triage of incoming cases to prioritize daily Adverse Event cases workflow management.
• Perform MedDRA coding, causality assessment, and narrative writing for global case submissions.
• Conducted peer quality review (QC) to ensure completeness and accuracy of ICSR data.
• Completion of training relating to relevant PV Agreements for assigned products ensuring regulatory consistency and compliance.
• Participation in inspections and audits as identified, including interviews and provision of requested data for post-market compliance verification.

• Evaluated physicochemical and biochemical properties of semi-finished products, raw materials, and bulk formulations as per required specifications.
• Prepared stability protocols and executed stability studies to ensure product shelf life under prescribed storage conditions.
• Performed process validations, equipment qualifications, and calibrations in compliance with GMP standards.
• Developed and implemented Standard Operating Procedures (SOPs), test standards, and instrument test procedures in accordance with regulatory and quality requirements.

• Executed pre-clinical trial activities in accordance with study protocols and organizational requirements.
• Handled study data management, statistical analysis, and reporting to meet organizational and regulatory submission standards.
• Ensured compliance of trial documentation and quality control processes in alignment with GLP and regulatory guidelines.