Summary
Overview
Work History
Education
Skills
Websites
Certification
THERAPUTIC AREAS
Languages
Timeline
Generic

ANITA CHAUDHARY

Raleigh,USA

Summary

Accomplished Pharmacovigilance and Drug Safety professional with over 10 years of experience driving patient safety and regulatory compliance in global clinical trials across CROs, pharmaceutical, and nonprofit healthcare sectors. Expert in safety case management, regulatory reporting, signal detection, and risk mitigation, with a proven track record of ensuring inspection readiness and supporting complex safety governance. Adept at collaborating with investigators, sponsors, vendors, and multidisciplinary teams to translate safety data into actionable insights and support informed decision-making. Highly skilled in PV systems including Oracle Argus, ARISg, Veeva Vault, and MedDRA, with comprehensive knowledge of FDA, EMA, ICH, and GVP standards. Holds an M.S. in Clinical Research Management with specialization in Drug Safety & Pharmacovigilance.

Overview

17
17
years of professional experience
1
1
Certification

Work History

Risk Management And REMS Strategy Intern

Syneos Health
Raleigh, NC, USA
01.2026 - Current
  • Analyzed REMS assessment methodologies, including audit criteria, noncompliance metrics, ETASU requirements, and communication strategies to evaluate risk-minimization effectiveness across programs.
  • Reviewed REMS assessment plans and supporting documentation to assess prescriber/patient knowledge evaluation, compliance monitoring, and health outcome metrics supporting harmonized measurement strategies.
  • Develop REMS Patient, Prescriber, and Pharmacy Guides for new programs, supporting ongoing risk communication and compliance.
  • Participate in cross-functional meetings and stakeholder communications to support day-to-day REMS activities.

Pharmacovigilance Associate II

FHI Clinical
Durham, NC
01.2025 - Current
  • Lead global clinical trial safety operations across all study phases (start-up through close-out), ensuring compliance with regulatory requirements.
  • Represent pharmacovigilance in study kick-off and client governance meetings, providing safety oversight and operational guidance.
  • Led cross-functional Safety Management Team (SMT) meetings, preparing agendas, safety analyses, presentations, and documentation to support data-driven decision-making.
  • Directed the configuration and User Acceptance Testing (UAT) for safety databases (Argus, Nukleus), ensuring robust SAE capture and high-fidelity data mapping.
  • Authored and maintained Safety Management Plans, SAE report forms, reconciliation plans, and safety SOPs, ensuring regulatory compliance, improving accuracy, and reducing reporting turnaround time by 25%.
  • Support signal detection activities, analyzing clinical and literature data, aggregate safety data to support proactive risk management.
  • Served as primary safety liaison for investigators, physicians, sponsors, and cross-functional teams to resolve data issues, monitor signals, and ensure timely follow-up.
  • Assist in preparation and analysis of safety data for aggregate reports (DSUR, PBRER), authoring assigned sections and coordinating with vendors for regulatory submissions.
  • Oversee safety reconciliation between EDC and safety databases to ensure data integrity and inspection readiness.
  • Delivered training on safety processes, database use, and reporting requirements to internal teams and 50+ global clinical sites, improving consistency and compliance.
  • Coordinated responses to ad hoc safety issues from regulatory authorities, clinical sites and sponsor.

Pharmacovigilance Associate I

FHI Clinical
Durham, NC
08.2022 - 01.2025
  • Led end-to-end processing of 2,500+ ICSRs, performing triage, MedDRA coding, narrative review, and quality control, maintaining 100% compliance.
  • Served as primary safety liaison with investigators, physicians, and sponsors to resolve data issues, support safety signal monitoring, and ensure timely case follow-up.
  • Supported Safety Physician in literature surveillance, ensuring relevant global safety findings were incorporated into signal detection activities.
  • Participated in PSRT/DSMB activities, preparing line listings, reviewing safety data, and tracking follow-up actions to support ongoing risk evaluation.
  • Led query escalation and resolution with cross-functional teams, ensuring timely closure and high data quality.
  • Managed reconciliation between clinical and safety databases, maintaining data integrity and inspection readiness.

TMF Specialist II

FHI Clinical
Durham, NC
03.2022 - 08.2022
  • Led global lifecycle management of paper and eTMF (setup through archival), ensuring compliance with ICH-GCP and regulatory requirements.
  • Authored TMF Management Plans and Master Indexes, aligning TMF structure with study milestones and operational workflows.
  • Directed TMF quality control frameworks, achieving >95% document accuracy and completeness across global trials.
  • Reduced QC errors by 30% through TMF process improvements and cross-functional training.
  • Maintained inspection-ready TMF health metrics and quality review packages supporting audits.
  • Managed document tracking, indexing, and discrepancy resolution ensuring TMF completeness.

Clinical Operations Intern

Intern, Clinical Operations
Durham, NC
05.2021 - 03.2022
  • Updated and maintained CTMS with study and site status according to project timelines.
  • Managed and tracked site regulatory documents, ensuring completeness and compliance with study requirements.
  • Conducted monthly TMF quality reviews to maintain inspection readiness and resolve documentation gaps.
  • Assisted with collection and review of investigator and regulatory documents from clinical sites.
  • Supported remote monitoring activities, including source data review and query follow-up with sites.
  • Supported Site Start-Up (SSU) activities by reviewing essential regulatory documents (ICFs, SRP packets) and tracking submissions.
  • Maintained study tracking logs and documentation to support site management and project reporting.
  • Assisted with clinical trial supply tracking, including investigational product and laboratory kits.
  • Communicated with investigative sites and internal teams to support document collection and site activation activities.

QA Specialist

Vovantis Laboratories Pvt. Ltd.
Vadodara, India
09.2012 - 09.2013
  • Managed end-to-end lifecycle of controlled documents (SOPs, work instructions, protocols, templates, reports), ensuring proper indexing, version control, and archival in compliance with regulatory requirements.
  • Monitored document completeness and accuracy to support internal and external audits, ensuring inspection readiness and regulatory compliance.
  • Supported CAPA management activities by documenting corrective and preventive actions, tracking progress, and aligning with audit findings and quality events.
  • Conducted impact assessments for document and process changes, collaborating with management and SMEs to evaluate operational and compliance implications.
  • Coordinated document review, approval, and training activities, ensuring timely completion and cross-functional compliance.

Quality Control Officer

Ind-Swift Ltd.
Chandigarh, India
06.2009 - 09.2011
  • Planned and coordinated QC testing activities (sampling, in-process, and stability) to support batch release timelines, ensuring compliance with GLP and GDP standards.
  • Scheduled, operated, and calibrated analytical instruments (FTIR, UV-Vis, Karl Fischer, pH, conductivity meters), ensuring data integrity, audit readiness, and uninterrupted laboratory operations.
  • Managed and maintained controlled documents (SOPs, specifications, STPs, protocols), supporting compliance and audit readiness.
  • Supported cross-functional coordination between QC, QA, and manufacturing teams, tracking workflows and ensuring timely completion of deliverables.

Education

M.S. - Clinical Research Management – Drug Safety & Pharmacovigilance

Rutgers University
New Jersey, USA
01-2026

Clinical Trials Research Associate Certification Program - CTRA - Core Competencies, CTRA - Data Management, CTRA - Advanced Topics

Durham Technical Community College
North Carolina, USA
01-2021

Bachelor of Pharmacy - undefined

Rajasthan University of Health Sciences
India
01-2009

Skills

  • Safety Oversight & Governance Safety Operations Management
  • ICSR Case Management SAE/SUSAR Processing Causality & Expectedness Assessment SAE/AESI Query Management & Escalation
  • Safety Database Configuration & Reconciliation Narrative Writing MedDRA & WHO-DD Coding
  • Signal detection & risk assessment Aggregate safety reporting (DSUR, PBRER) REMS/RMP evaluation
  • Literature surveillance Safety data analysis Medical writing Regulatory submission
  • Vendor Oversight Cross-Functional Collaboration Sponsor & Site Interaction
  • Oracle Argus, ARISg, Viva Vault, Empirica, Nukleus CTMS
  • Coding & dictionaries: MedDRA, WHO-Drug
  • Aggregate Reports (DSURs, PSURs) Safety Management Plans (SMPs) Reconciliation Plans Line Listings CSR Writing
  • Health Authority Inspection Support Sponsor & Regulatory Audits Inspection Readiness
  • Pharmacovigilance Regulations: FDA EMA SAHPRA ICH E2E GVP CIOMS
  • TMF Systems: Trial Interactive PhlexTMF Veeva Vault QC Review
  • Safety Training & Mentorship Site & Investigator Safety Training
  • Scientific Literature Review: PubMed Embase Safety Data Abstraction
  • Risk Management RMP/REMS, Signal Detection
  • Documentation & Systems: Microsoft Office SharePoint Spreadsheet

Websites

Certification

  • Advanced training in global pharmacovigilance regulatory frameworks (FDA, EMA, ICH E2E, CIOMS, GVP) with application to clinical trial safety oversight and regulatory reporting.
  • Applied knowledge of risk management frameworks, including REMS/RMP development, benefit–risk assessment, and structured safety decision-making across the product lifecycle.
  • Practical exposure to signal detection methodologies, including literature surveillance, case series review, disproportionality concepts, and qualitative/quantitative approaches for safety signal identification and evaluation.
  • Academic experience in safety data analysis, literature review, and evidence synthesis to support safety evaluations, aggregate reporting, and risk communication.
  • Exposure to public real-world databases (e.g., FAERS, EHR) for data extraction, basic data cleaning, and interpretation of safety data.
  • Certifications & Training: CITI (GCP – Drugs/Devices), MSSO MedDRA UMC Signal Detection

THERAPUTIC AREAS

Infectious Diseases (COVID-19, TB, HIV, Malaria), Oncology (Phase I-III)

Languages

English
Full Professional

Timeline

Risk Management And REMS Strategy Intern

Syneos Health
01.2026 - Current

Pharmacovigilance Associate II

FHI Clinical
01.2025 - Current

Pharmacovigilance Associate I

FHI Clinical
08.2022 - 01.2025

TMF Specialist II

FHI Clinical
03.2022 - 08.2022

Clinical Operations Intern

Intern, Clinical Operations
05.2021 - 03.2022

QA Specialist

Vovantis Laboratories Pvt. Ltd.
09.2012 - 09.2013

Quality Control Officer

Ind-Swift Ltd.
06.2009 - 09.2011

Clinical Trials Research Associate Certification Program - CTRA - Core Competencies, CTRA - Data Management, CTRA - Advanced Topics

Durham Technical Community College

Bachelor of Pharmacy - undefined

Rajasthan University of Health Sciences

M.S. - Clinical Research Management – Drug Safety & Pharmacovigilance

Rutgers University

Similar Profiles

  • Diego Mpia ElengeDiego Mpia Elenge

    Associate Medical Director, Safety Evaluation & Risk Management at GSKAssociate Medical Director, Safety Evaluation & Risk Management at GSK

  • Jagdish ChaudharyJagdish Chaudhary

    <ul><li>Key Role: Heading the HSE & AI department and acting as a Senior Management Personnel (SMP)</li><li>Responsibilities:</li><li>Corporate HSE & AI Functions:</li><li>Developed and implemented IRM’s HSE & AI policy and management system.</li><li>Spearheaded leadership development and safety culture initiatives across all levels.</li><li>Facilitated internal and external HSE communications and corporate-level engagement programs.</li><li>Oversaw compliance for ERDMP certification, PCB consents, and environmental audits.</li><li>Led HSE training strategy including induction programs and annual training calendars.</li><li>Initiated and monitored HSE & AI performance improvement plans and audits.</li><li>Developed strategic safety KPIs, trend analysis, and corporate-level MIS reporting.</li><li>Managed safety tours, incident investigations, and safety reward programs.</li><li>Championed process safety, MOC, RCA reviews, and critical safety studies.</li><li>Ensured effective GA-level implementation of HSE policies and risk management.</li><li>Conducted safety campaigns, mock drills, and employee engagement activities.</li><li>Geographical Area (GA) Operations HSE & AI Oversight:</li><li>Engaged field teams and contractors for proactive HSE compliance and audits.</li><li>Reviewed and maintained Asset Integrity systems including HAZOP, QRA, and Risk Registers.</li><li>Participated in PNGRB, IMS audits and implemented corrective actions at GA level.</li><li>Facilitated incident reporting to authorities and supported root cause investigations.</li><li>Supported GA-level environmental and emergency preparedness programs.</li></ul> at IRM Energy Limited<ul><li>Key Role: Heading the HSE & AI department and acting as a Senior Management Personnel (SMP)</li><li>Responsibilities:</li><li>Corporate HSE & AI Functions:</li><li>Developed and implemented IRM’s HSE & AI policy and management system.</li><li>Spearheaded leadership development and safety culture initiatives across all levels.</li><li>Facilitated internal and external HSE communications and corporate-level engagement programs.</li><li>Oversaw compliance for ERDMP certification, PCB consents, and environmental audits.</li><li>Led HSE training strategy including induction programs and annual training calendars.</li><li>Initiated and monitored HSE & AI performance improvement plans and audits.</li><li>Developed strategic safety KPIs, trend analysis, and corporate-level MIS reporting.</li><li>Managed safety tours, incident investigations, and safety reward programs.</li><li>Championed process safety, MOC, RCA reviews, and critical safety studies.</li><li>Ensured effective GA-level implementation of HSE policies and risk management.</li><li>Conducted safety campaigns, mock drills, and employee engagement activities.</li><li>Geographical Area (GA) Operations HSE & AI Oversight:</li><li>Engaged field teams and contractors for proactive HSE compliance and audits.</li><li>Reviewed and maintained Asset Integrity systems including HAZOP, QRA, and Risk Registers.</li><li>Participated in PNGRB, IMS audits and implemented corrective actions at GA level.</li><li>Facilitated incident reporting to authorities and supported root cause investigations.</li><li>Supported GA-level environmental and emergency preparedness programs.</li></ul> at IRM Energy Limited

  • Richard Morman, ARM, CPCU, CRISRichard Morman, ARM, CPCU, CRIS

    Director of Insurance & Enterprise Risk Management at Cubic CorporationDirector of Insurance & Enterprise Risk Management at Cubic Corporation

  • Simon Zhou QinYangSimon Zhou QinYang

    Risk Control Strategy Leader - Global E-commerce at TikTok/BytedanceRisk Control Strategy Leader - Global E-commerce at TikTok/Bytedance

CREATE PROFILE