Dr. Jacek Stanislaw Bulicz

The R&D Quality Strategy Development Lead is responsible for managing the development program activities from the quality perspective (GCP, GVP, GLP, GMP, GRP), proactively identifies risk areas, provides inspections and audits strategies, provides expertise during due diligence process, leads multidisciplinary teams. Quality Strategy Leads design and implement risk-based approaches on respective quality assurance oversight activities and strategy to ensure fit for purpose quality of the deliverables.

Working in the Global Patient Safety Medicine Group as a GPS Leader. Responsibilities: broad GVP expertise, contributing to effective proactive safety strategies for the assigned development compound(s) or marketed product(s), risk management and benefit-risk evaluation, medical evaluation of ICSRs, safety signal detection and evaluation, creation and delivery of aggregated periodic safety reports, evaluation and implementation of risk mitigation activities, delivery of safety aspects of clinical trials.

- Legal function as Deputy German Commissioner for the Graduated Plan (Stufenplanbeauftragter) -Collection, translation and Local assessment of national Individual Case Safety Reports (ICSR) - Local PSMF maintenance - Literature surveillance -HA communication Planning, approval, conduct and evaluation of all local clinical studies (CT, NIS, ISS) -Submission of all local studies to HA and ECs -GCP training of local CT teams -Answering local requests from EC and local HA