Providing safety expertise and leadership to team crafting Integrated Summary of Safety and Clinical Study Reports for NDA submission to FDA.
Collaborating with national association to develop and deliver continuing educational material (live presentations; webcasts; discussion guide) on REMS and international pharmaceutical risk management for pharmacists and physicians.
Serving as drug safety and pharmacoepidemiology external expert for company awarded contract by FDA to evaluate its Center for Drug Evaluation and Research (CDER) postmarketing spontaneous adverse event surveillance system.
Evaluating new global pharmacovigilance database system and associated operations for state-of-the-art functionality and compliance with national and international regulatory requirements for international pharmaceutical company.
Performing audit of postmarketing pharmacovigilance activities, including product complaint handling, to prepare international pharmaceutical company headquarted in US for FDA inspection.
Presenting two-day in-house training course in Clinical Safety and Pharmacovigilance at Asian headquarters of international pharmaceutical company.
Assessing company-wide signal detection activities for international pharmaceutical company headquarted in Europe.
Analyzing safety department of medical device company, including its scope and organizational structure, along with strategic planning for globalization within the international company.
Preparing companies for pre- and postmarketing meetings with competent authorities, including participating in mock Advisory Committee meetings and assisting in responses to regulatory questions.