My Areas of Expertise

Pharmacovigilance/Drug Safety & Clinical Development

• Signal Detection & Evaluation
• Risk Management Plans (RMPs, aRMMs)
• Aggregate Reports: PSURs, PBRERs, DSURs, PADERs
• Literature Review Clinical Study Reports (CSR) and Investigator Brochures (IB) Medical Review
• Summary of Clinical Safety & Integrated Summary of Safety
• Product Label and Ad Hoc Safety Updates for Regulatory Authorities

Technological Tools & Strategy

• Generative AI Mastermind (2024) – Certified to strategically drive AI breakthroughs across pharmacovigilance and clinical drug development
• AI-integrated PV Strategy & Automation (EMPIRICA, SPOTFIRE, LiTRACE, MICC, SigTRACE)
• Electronic Data Capture IN ClinicalL & Safety Databases (ORACLE CLINICAL, MEDDATA, CLINTRIAL, e-CLINICAL SUITE, RAVE, ARGUS, ARISg, PV 24X7, SCEPTRE, Veeva)
• SOP Development, Compliance, Audit & Inspection Readiness
• Literature, Signals & Risk Management Platforms

Therapeutic Area Knowledge & Targeted Products

• Immunology & Dermatology
• Oncology incl. Precision Oncology
• Cardiovascular & Metabolic Disorders
• Neuroscience & Psychiatry
• Infectious Diseases & Vaccines (incl. Sputnik V)
• Biologics, Biosimilars, Radioligand Therapuetics; and Cell & Gene Therapies