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