Deepak Chawla

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.

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

PhD - Pharmacovigilance - Sunrise University (2019 - 2025)

M.Pharmacy - Pharmaceutics - Kurukshetra University (2009 - 2011)

B.Pharmacy - Kurukshetra University (2005 - 2009)