Deepak Chawla

Pharmacovigilance and Medical Safety Writing professional

Haldwani, NainitalMember since March 3, 2026

Medical Safety WritingICSR case processingCase intakeTriageData entryMedDRA codingNarrative writingFollow-up managementQuality reviewCausality assessmentComplianceBenefit–Risk EvaluationSafety Data AnalysisLiterature ReviewPubMedFDAEMAPharmacovigilanceOracle Argus SafetyMedDRA

About

Pharmacovigilance and Medical Safety Writing professional with over 7+ years of combined experience across industry and academic research, including hands-on experience in authoring and reviewing aggregate safety reports for global regulatory submissions. Proven expertise in PSUR, PBRER, PADER, and DSUR in compliance with ICH, FDA, and EMA guidelines. Strong background in safety data analysis, literature review, and benefit–risk evaluation, with a track record of delivering reports within strict regulatory timelines.

Proficient in Oracle Argus and MedDRA with demonstrated experience in cross-functional collaboration and regulatory compliance.

Experience

Business Process Lead – Pharmacovigilance & Medical Writing - Tata Consultancy Services (TCS)

(2018-02 - 2018-06)

Authored and reviewed PSUR, PBRER, PADER, and DSUR for global regulatory submissions
Performed QC review ensuring scientific accuracy and compliance with ICH guidelines
Conducted safety data analysis and benefit–risk evaluation using clinical and post-marketing data
Collaborated with cross-functional teams for data validation and report finalization
Supported regulatory authority responses and safety-related queries within defined timelines

Aggregate Report Writer - Sciformix Technologies (now part of Fortrea)

(2016-05 - 2018-01)

Authored PSURs, PADERs, and safety sections for global regulatory submissions
Delivered multiple aggregate safety reports within strict regulatory timelines
Conducted literature review and cumulative safety analysis using PubMed and regulatory sources
Reviewed ICSRs, narratives, and line listings for accuracy and consistency
Participated in QC and peer review activities ensuring submission readiness and compliance

Pharmacovigilance Associate - Symogenesis

(2014-01 - 2014-11)

Performed end-to-end ICSR case processing including case intake, data entry, triage, MedDRA coding, narrative writing, follow-up management, quality review, and causality assessment in compliance with pharmacovigilance requirements.
Ensured data accuracy in Oracle Argus database
Supported quality checks and timely safety reporting in line with regulatory requirements

People Operations & Documentation Executive (HR Executive) - Kurukshetra Institute of Professional Studies (KIPS)

(2012-01 - 2016-04)

Managed structured documentation, SOPs, and internal records ensuring compliance
Coordinated cross-functional communication to support operational efficiency
Ensured data accuracy, confidentiality, and audit readiness of organizational records