Avula Chandra Mouli serves as a Pharmacovigilance & Drug Safety Advisor to Novira Life Sciences, bringing over 9 years of specialized industry experience across global CROs and pharmaceutical safety operations. In his advisory capacity, he provides strategic guidance and technical oversight on clinical trial safety operations, Individual Case Safety Report (ICSR) management, literature surveillance frameworks, and global safety submission workflows across the UK, Europe, the US, and international regions.

He holds a Master of Pharmacy (M.Pharm) degree from Jawaharlal Nehru Technological University, Hyderabad, and possesses deep domain expertise in multi-platform safety database environments, including Argus (8.2.3, 8.4.4.1), ArisG (6.8, 7.4), Agxchange, and EVWEB. His technical background spans the complete lifecycle of pharmacovigilance—including triage, case intake, duplicate management, literature validity assessments, medically relevant safety narrative creation, and multi-level Quality Control (QC).

Having served in senior drug safety and safety science roles across major global CROs—including Fortrea, Syneos Health, and Tata Consultancy Services—Chandra Mouli brings extensive hands-on experience in managing complex case types, including Spontaneous, Solicited, Literature, Clinical Trial, and expedited Suspected Unexpected Serious Adverse Reactions (SUSARs) and Serious Adverse Events (SAEs). His operational background includes root-cause analysis for reporting timelines, Corrective and Preventive Action (CAPA) preparation, audit readiness, and safety database automation workflows.

As a Pharmacovigilance Advisor, Chandra Mouli advises Novira Life Sciences on optimizing drug safety workflows, aligning safety data management with ICH-GCP guidelines, GVP modules, and ALCOA+ data integrity principles, and establishing rigorous associate training and quality assurance frameworks for client-sponsored trial programs.

dr-avula-chandra-mouli

M.Pharm

Areas of Advisory Expertise

  1. Pharmacovigilance & CRO Safety Strategy (9+ Years Industry Experience)
  2. ICSR Processing & Management (Spontaneous, Solicited, Literature, Clinical Trial & SUSAR)
  3. End-to-End Safety Workflow Oversight (Triage, Data Entry, QC & Regulatory Submissions)
  4. Literature Safety Surveillance & Validity Assessment Frameworks
  5. Enterprise Safety Databases: Argus (8.2.3, 8.4.4.1), ArisG (6.8, 7.4), Agxchange & EVWEB
  6. Medically Relevant Safety Narrative Standards & Causality Assessments
  7. Audit Preparedness, Inspection Readiness & CAPA Governance
  8. Aggregate Safety Reporting Standards (PSUR / DSUR Support & Latency Tracking)
  9. ICH-GCP Standards, GVP Modules & ALCOA+ Data Integrity Principles
  10. Pharmacovigilance Quality Assurance & Onboarding Frameworks

Advisory & Professional Background

  1. Pharmacovigilance Advisor – Novira Life Sciences (Advisory Role)
  2. Lead Safety Science Specialist – Fortrea
  3. Former Senior Safety & PV Roles at Syneos Health & Tata Consultancy Services

Education & Certifications

  1. M. Pharmacy – Jawaharlal Nehru Technological University (JNTUH), Hyderabad, India
  2. B. Pharmacy – Jawaharlal Nehru Technological University (JNTUA), Anantapur, India
  3. Certification Program in Pharmacovigilance Aggregate Reporting

Location

  1. India