A physician, >20 years of experience. After working for several years as Vice President and Global Head of Drug safety & risk management for a mid-size company, I have started my own pharmacovigilance company in 2019. I fully understand the regulators perspective and compliance requirements for pharmacovigilance globally. I have successfully hosted several GVP and PADE inspections as the most responsible person for pharmacovigilance without any critical or major finding. I have experience in Pharmacovigilance, safety monitoring during clinical development, medical writing, preclinical studies and patient care. I set-up and successfully led efficient and regulatory compliant Global Safety function for two mid-size companies. I was a key member for clinical development and safety management of NCEs and biosimilars in 3 companies.

Now, I’m looking forward to supporting pharma companies as Consultant for- Development of Pharmacovigilance strategy & planning; Pharmacovigilance inspection readiness; Potential acquisitions Due diligence, Gap Analysis of potential acquisitions; Advise/ lead on integration and merger of new acquisitions or multiple databases; Support for setting-up of compliant, efficient, cost effective in-house PV department or specific PV processes; Gap Analysis: Review of the current processes; Preparation & Training of SOPs; Pharmacovigilance Inspection Remediation including post inspection support in preparation of the response and planning and implementation of CAPAs; pharmacovigilance auditing & conducting mock inspections and safety monitoring in clinical development