·       Drug Safety and Risk Management during clinical development and the marketed period

o    Risk- and Crisis management including prevention of calamities by implementing the necessary  infrastructure

o    Advice on set up, coordination and execution of specific safety studies (all clinical trials and epidemiological studies)

o    Review Pharmacovigilance workflow, processes and organisation

o    Review of Risk Management plans and Risk Mitigation plans

o    Delivery of teachings and workshops

o    Liability, claims and causality assessments, including medico-legal advice

o    Review of periodic reports like PSURs, ASRs and the like

o    Review and assessment of in-house data

o    Review of Investigators Brochures and Patient materials

o    Review of prescribing variations, whether requested by the company or by regulatory authorities 

o    Advice on Drug-Drug-Substance interactions, pharmacogenetics, polymorphism and metabolic pathways for companies and prescribers

·         Extensive network with governmental bodies, universities & academics and pharmaceutical
   industry 

·         Worked in / and with different cultures including the Japanese and the Indian

·         Communication skills     

·         Practical and pragmatic

·         Coaching

·         Performance driven

·         Experienced

·         Ethical

·         Open

·         Mindful

·         Spiritual