Anshul Dixit

Results-driven Pharmacovigilance professional with 2+ years of hands-on experience in aggregate safety reporting (PADER and PSUR/PBRER), signal management and case processing across multi-client CRO operations. Consistently delivers 100% on-time, audit-ready regulatory submissions in compliance with FDA, ICH-E2, and global GVP guidelines. Combines a Doctor of Pharmacy (PharmD) clinical background in inpatient care and antibiotic stewardship with strong PSUR/PBRER authoring, literature surveillance, REMS documentation, and eCTD publishing (KNET) expertise.

Promoted to Medical Safety Executive in recognition of consistent accuracy, regulatory intelligence, and cross-functional collaboration that strengthens client risk-benefit profiles. Seeking senior Medical Safety / Aggregate Reporting roles within global CROs and pharmaceutical organizations.

Medical Safety Executive, Pharmacovigilance Department at COD Research Pvt. Ltd. (2026-04 – Present)

Promoted from Medical Safety Associate in recognition of consistent performance, regulatory accuracy, and cross-functional collaboration

• Authoring and reviewing US-PADER aggregate safety reports across multiple client portfolios spanning diverse therapeutic areas, maintaining 100% on-time regulatory submission compliance
• Leading development and review of signal management reports, enabling early identification of potential safety signals through integrated data analysis and literature review to strengthen client risk-benefit assessments
• Contributing to PSUR/PBRER authoring and review, ensuring alignment with ICH-E2 periodic safety update reporting requirements and internal quality standards
• Conducting systematic literature surveillance and regulatory intelligence screening, ensuring new safety information is captured within mandated reporting timelines
• Building and maintaining accurate line listings using MS Excel and PvEDGE Safety Database, and supporting a data migration initiative from the Argus Safety platform, improving data traceability and audit readiness across client accounts
• Supporting SOP development and inspection-readiness initiatives, contributing to zero major findings during internal quality reviews
• Coordinating with cross-functional regulatory, clinical, and quality teams across multiple client engagements to ensure consistent compliance tracking

Medical Safety Associate, Pharmacovigilance Department at COD Research Pvt. Ltd. (2024-07 – 2026-03)

• Authored and reviewed US-PADER aggregate safety reports across multiple client portfolios spanning diverse therapeutic areas, maintaining 100% on-time regulatory submission compliance
• Led development and review of signal management reports, enabling early identification of potential safety signals through integrated data analysis and literature review to strengthen client risk-benefit assessments
• Contributed to PSUR/PBRER authoring and review, ensuring alignment with ICH-E2 periodic safety update reporting requirements and internal quality standards
• Conducted systematic literature surveillance and regulatory intelligence screening, ensuring new safety information was captured within mandated reporting timelines
• Built and maintained accurate line listings using MS Excel and PvEDGE Safety Database, and supported a data migration initiative from the Argus Safety platform, improving data traceability and audit readiness across client accounts
• Supported SOP development and inspection-readiness initiatives, contributing to zero major findings during internal quality reviews
• Coordinated with cross-functional regulatory, clinical, and quality teams across multiple client engagements to ensure consistent compliance tracking

Clinical Pharmacist (Internship) at Apollo Hospitals International (2023-07 – 2024-06)

• Proactively identified, assessed, and documented adverse drug reactions (ADRs) and drug interaction risks through clinical pharmacy review, applying causality-assessment principles consistent with pharmacovigilance practice
• Delivered medication therapy management (MTM) and patient counselling to inpatients, supporting safe medication use across high-acuity hospital units
• Implemented antibiotic stewardship practices, contributing to optimized antimicrobial use, reduced inappropriate prescribing, and improved quality of patient safety data
• Administered IV therapy and supported inpatient care protocols in coordination with multidisciplinary clinical teams, reinforcing a strong foundation in patient safety monitoring

Science Faculty (Part-time) at Keystone Universe of Education (2023-07 – 2024-06)

• Delivered subject instruction emphasizing critical thinking and laboratory skills, applying structured classroom management techniques

Doctor of Pharmacy in PharmD – Saraswati Institute of Pharmaceutical Sciences (Affiliated by GTU) (2018 – 2024)

Senior Secondary – Shiv Ashish School (2012 – 2018)