Shadab Haroon Memon
Pune
Summary
Pharmacovigilance professional with 9+ years of experience in ICSR processing, drug safety operations, quality review, and regulatory compliance. Expertise in Argus and LSMV, including LSMV migration, validation, and training. Experienced in team leadership, workload allocation, quality improvement, audit readiness, and stakeholder management. Proven Subject Matter Expert and trainer with a strong track record of driving process improvements and delivering high-quality pharmacovigilance operations.
Overview
2
2
years of post-secondary education
9
9
years of professional experience
Work History
Lead Safety Science Specialist
Fortrea drug development
Pune
09.2024 - Current
- Led daily team allocation and case distribution based on real-time case inflow, optimizing workload balance and ensuring SLA adherence.
- Monitored team performance through productivity, quality, turnaround time, compliance, and error-trend metrics.
- Reviewed team deliverables and provided constructive feedback to improve case quality and reduce recurring errors.
- Prepared and presented operational updates, productivity reports, quality trends, SLA dashboards, and action plans to management and stakeholders.
- Performed project management activities including stakeholder coordination, metrics tracking, SLA monitoring, quality checks, and monthly reporting.
- Acted as Subject Matter Expert for intake, case processing, resolving technical and procedural queries across solicited, spontaneous, literature, and clinical trial report types.
- Served as primary escalation point for intake-related issues, providing technical resolutions and process clarifications to maintain data quality and regulatory compliance.
- Implemented quality checks at intake to identify incomplete or invalid reports, driving improvements in downstream processing and case validity rates.
- Identified quality trends, conducted root cause analysis, and delivered refresher trainings, enhancing compliance and decreasing error rates.
- Collaborated with internal and external stakeholders to deliver high-quality outputs aligned with SLAs and project timelines.
- Successfully participated in and faced Pharmacovigilance audits, effectively addressing auditor queries, presenting process-related information, and ensuring timely closure of audit observations in compliance with regulatory and quality requirements.
- Supported audit and inspection readiness activities; assisted in CAPA implementation and quality issue resolution.
Fortrea drug development
Safety Data Analyst
Pune
06.2020 - 08.2024
- End-to-end ICSR processing including intake, triage, case entry quality review (QC), medical coding, narrative writing, in LSMV and Argus.
- Key contributor to Argus to LSMV migration; worked as a trainer delivering system and process training.
- Proposed innovative ideas and solutions that improved team performance and outcomes.
- Worked on LSMV validation during before migration
- Managed intake and processing of legal cases to ensure compliance with regulatory and client-specific requirements.
- Trained and coached associates on intake and case processing standards for all report types (solicited, spontaneous, literature, clinical trials) to enhance team competency and consistency.
- Managed expedited reporting to global regulatory authorities, ensuring compliance with FDA, EMA, MHRA, and ICH-GCP guidelines within established timelines.
- Served as Subject Matter Expert (SME) for LSMV transition, resolving user queries and coordinating with IT and system teams for issue resolution and system enhancements.
- Support & contribute to on boarding, training, mentoring and coaching of new associates
Senior Clinical Process Associate
Tata Consultancy Services
Mumbai
07.2017 - 06.2020
- End-to-end ICSR processing including intake, triage, case entry quality review (QC), medical coding, narrative writing, in LSMV and Argus
- Conducted quality review of clinical trial documentation including Investigator Agreements, Informed Consent
- Forms (ICF), Financial Disclosure Forms, IRB/Ethics Committee approvals, CVs, IP accountability logs, dispensing/destruction logs, delegation logs, and laboratory documents.
- Supported sponsor clinical trials across multiple therapeutic areas, ensuring compliance with ICH-GCP, regulatory and sponsor-specific guidelines
- Conducted periodic eTMF reviews (Country and Sponsor Master File) to maintain audit and inspection readiness.
- Supported audit and inspection activities by ensuring TMF completeness, accuracy, and regulatory compliance.
- Managed query management reports to track outstanding issues., followed up with site teams for observation closure, and ensured timely resolution of outstanding issues.
- Collaborated with Automation (BOT) and IT teams for artifact uploads into Pharma TMF systems and performed
- Quality Control (QC) checks for correct document indexing in TMF zones and sub-zones.
- Managed business requirements documentation and guided technical teams on eTMF system enhancements and process alignment.
- Performed interim eTMF exports/uploads for study milestones and sponsor deliverables.
- Mentored and trained new associates on TMF processes, PV activities, quality standards, and SOP compliance.
Education
Master of Pharmacy - Pharmacology
Savitribai Phule Pune University
06.2015 - 06.2017
Bachelor of Pharmacy -
Savitribai Phule Pune University
Skills
- ICSR processing
- Regulatory reporting
- Quality review
- Quality management
- Argus Safety
- LifeSphere Safety Multivigilance
- CAPA management
- Audit readiness
- Project oversight
- Performance Analytics
- Stakeholder relations
- Training
- Medical coding
Languages
- English
- Hindi
- Marathi
Achievements And Awards
- Awarded Performer of the Year (2023) for outstanding contribution to Pharmacovigilance operations and quality excellence.
- Recognized as Subject Matter Expert (SME) of the Year (2022) for expertise in safety database systems and process improvements.
- Awarded for delivering Outstanding Quality Product with consistent compliance to regulatory standards and SLA timelines.
- Received Star Performer Award (Twice) for exceptional performance and operational excellence.
- Honored with On-the-Spot Award (Twice) for successful eTMF reconstruction and timely study support within defined timelines.
- Supported multiple FDA inspections, ensuring audit readiness, regulatory compliance, and successful study outcomes.
- Contributed to MHRA and CDQA inspections, maintaining TMF completeness and quality standards.
- Qualified GPAT (All India Level Examination, 2014-2015) demonstrating strong academic and pharmaceutical knowledge.
- Winner of AVISHKAR 2016 (University Level Research Competition) for research presentation.
- Presented research at 3rd International Conference on Herbal and Synthetic Drug Studies (HSDS 2016) (Poster Presentation).
- Presented at National Pharmacy Week (NPW) and University-level research forums.
Disclaimer
I hereby declare that the information provided above is true and correct to the best of my knowledge and belief.
Timeline
Lead Safety Science Specialist
Fortrea drug development
09.2024 - Current
Fortrea drug development
Safety Data Analyst
06.2020 - 08.2024
Senior Clinical Process Associate
Tata Consultancy Services
07.2017 - 06.2020
Master of Pharmacy - Pharmacology
Savitribai Phule Pune University
06.2015 - 06.2017
Bachelor of Pharmacy -
Savitribai Phule Pune University