My Areas of Expertise

Pharmacovigilance & Drug Safety

• Signal Detection & Evaluation
• Risk Management Plans (RMPs, aRMMs)
• Aggregate Reports: PSURs, PBRERs, DSURs, PADERs
• Literature Screening and Safety Narrative Writing
• Clinical Study Report (CSR) and Investigator Brochure (IB) Medical Review
• Periodic and Ad Hoc Safety Updates for Regulatory Authorities

Technological Tools & Strategy

• AI-integrated PV Strategy & Automation (e.g., EMPIRICA, SPOTFIRE, SigTRACE)
• Electronic Data Capture IN ClinicalL & Safety Databases (ORACLE CLINICAL, MEDDATA, CLINTRIAL, e-CLINICAL SUITE, RAVE, ARISg, ARGUS, PV 24X7, Veeva)
• SOP Development, Compliance & Audit Readiness
• Literature Management Platforms

Therapeutic Area Knowledge

• Immunology & Dermatology
• Oncology
• Cardiovascular & Metabolic Disorders
• Neuroscience & Psychiatry
• Infectious Diseases & Vaccines (incl. Sputnik V)
• Biosimilars & Biologics