Venkatesh Natarajan

Experienced MBBS Pharmacovigilance Physician with hands-on expertise in ICSR medical review, causality assessment, seriousness and listedness/expectedness determination, and MedDRA coding. Currently performing primary medical review of Individual Case Safety Reports (ICSRs) at Fortrea, covering clinical trial, literature, and combination product (drug-device) cases. Proficient in Argus Safety Database, GVP/ICH-GCP regulatory guidelines, narrative review, follow-up query management, and cross-functional collaboration with clients, safety scientists, and therapeutic teams.

Demonstrated ability to mentor junior physicians and act as a Subject Matter Expert (SME) within regulated pharmacovigilance environments.

Medical Physician Specialist – Pharmacovigilance - Fortrea - Chennai, India

(2025-06)

• Perform primary medical review of Individual Case Safety Reports (ICSRs) for accuracy, completeness, and regulatory compliance, including complex clinical trial and drug-device combination product cases.
• Conduct medical assessment for seriousness, causality, expectedness/listedness, and clinical significance of reported adverse events.
• Review and validate case narratives, medical histories, laboratory data, and concomitant medications for medical coherence.
• Provide medical inputs to case processing team; raise follow-up queries to reporters and Health Care Professionals (HCPs).
• Verify appropriate selection of adverse events from source documents; assign appropriate MedDRA codes; review narratives.
• Support aggregate reporting and signal detection analysis in accordance with pharmacovigilance standards and global regulatory requirements.
• Ensure compliance with client SOPs, GVP guidelines, and regulatory reporting timelines; utilize Argus Safety Database for case workflow.
• Collaborate with safety associates, data management teams, and quality reviewers to maintain KPI metrics and high-quality case processing standards.
• Provide guidance to junior physicians on case assessment methodologies; support audit and inspection readiness activities.

Medical Director - Smart Vision Health - Chennai, India

(2022-03 - 2025-05)

• Led preventive healthcare and wellness initiatives across corporate and educational sectors, coordinating multidisciplinary healthcare programs.
• Developed health awareness programmes focused on chronic disease prevention and early detection; worked with organisations supporting individuals with special needs through CSR healthcare activities.

Consultant – Diabetes & Metabolic Medicine - Dr. Mohan's Diabetes Specialities Centre - Chennai & Tirupur, India

(2020-09 - 2022-02)

• Managed patients with diabetes, metabolic disorders, and post-COVID hyperglycemia
• Presented clinical topics including ADA Updates 2021, association of Pioglitazone and urinary bladder carcinoma, and non-diabetic causes of nephropathy in diabetic patients.
• Acquired strong grounding in medical terminology, pharmacology, and therapeutic risk-benefit assessment.

Chief Medical Officer - Dr. Kamakshi Memorial Hospital Pvt Ltd - Chennai, India

(2019-05 - 2020-03)

• Established multispecialty primary care clinics; implemented preventive care initiatives and referral coordination.
• Developed clinical documentation and SOP frameworks aligning with regulatory compliance standards.

Physician - K.M. Hospitals - Chennai, India

(2018-09 - 2019-04)

• Provided clinical evaluation and treatment across diverse patient populations in NABH-accredited settings; completed basic clinical training (internship/residency) reinforcing strong medical terminology and patient care competency.

Bachelor of Medicine, Bachelor of Surgery - MBBS - Sri Ramachandra Institute of Higher Education and Research (2018)