Specialties: Clinical and post-marketing PVG/Patient Safety; Regulatory Affairs; Medical & Scientific Writing (including regulatory documents and feasibility reports as components of pharmaceutical product development process in the CRO environment); Medicine & Health Care; and Clinical - Preclinical Research (Clinical Neurophysiology - Neuroscience).

Medical Director - Safety and Benefit-Risk Management @ From October 2013 to Present (2 years 3 months) Safety Physician @ From October 2012 to October 2013 (1 year 1 month) Raleigh-Durham, North Carolina AreaSafety Physician Coordinator (Pharmacovigilance) @ From October 2011 to October 2012 (1 year 1 month) Raleigh-Durham, North Carolina AreaSafety Specialist @ From October 2009 to November 2011 (2 years 2 months) Integrated Product Development Associate @ PVG (clinical & post-approval services, medical safety monitoring), regulatory affairs; product development & program/project management, feasibility reports/services, medical writing (CSR, protocols, narratives, SOPs) From March 2008 to October 2009 (1 year 8 months) Regulatory Affairs @ From 2008 to 2009 (1 year) Research Scientist @ Conducted pre-clinical research in neurophysiology. From September 1997 to September 2007 (10 years 1 month) ER Physician/General Practitioner & Medical Director @ • Acted as attending physician for ER in 24-hour shifts, • Served as the medical director during rotations in the state hospital's satellite public health units, • Served as primary care physician and trained and supervised the junior staff (nurses and medical technicians) during rotations in the public health units. From August 1988 to September 1997 (9 years 2 months)

Doctor of Medicine (MD), Medicine @ Aegean University, School of Medicine (Ege Univ., Tip Fak.)Master of Science (MS), Biomedical/Medical Engineering @ Bosphorus University, Biomedical Engineering Institute (Bogaziçi Üniv., Biyomedikal Muh. Enstitusu)Doctor of Philosophy (PhD), Clinical Neurophysiology & Biomedical Sciences @ Bosphorus University, Biomedical Engineering Institute (Bogaziçi Üniv., Biyomedikal Muh. Enstitusu)Doctor of Philosophy (Ph.D.), Neurobiology and Neurosciences @ Duke UniversityFen Lisesi Gülden MS is skilled in: Pharmacovigilance, Drug Safety, Clinical Trials, CTAs, Drug Development, Medicine, Neuroscience, Hospitals, CRO, Clinical Development, Therapeutic Areas, Gastroenterology, Oncology, Hematology, Infectious Diseases