Dilara Yuksel Gunbay | Associate Director, Patient Safety, AHoPS
Gilead Sciences

NAME: Dilara YUKSEL GUNBAY Gilead: Associate Director Patient Safety AHoPS 01 March 2023- present Ensuring that local pharmacovigilance activities are conducted such that the Affiliate(s) is in compliance with regulatory and internal company standards as set out within applicable regulations or guidance and global or local Procedural Documents (PDs). Overseeing the local Quality Management System Maintaining local knowledge Serving as the point of contact within the Affiliate Managing all aspects of local Individual Case Safety Report (ICSR) Management Utilising and proactively participating in the AHoPS Network and accessing available PVE resources Gilead: Senior Manager GLPS 26 June 2019 – March 2023 Ensuring that local pharmacovigilance activities are conducted such that the Affiliate(s) is in compliance with regulatory and internal company standards as set out within applicable regulations or guidance and global or local Procedural Documents (PDs). Overseeing the local Quality Management System Maintaining local knowledge Serving as the point of contact within the Affiliate Managing all aspects of local Individual Case Safety Report (ICSR) Management Utilising and proactively participating in the PRP Network and accessing available PVE resources Amgen İlaç Tic. Ltd. Şti.: Global Safety Manager December 2011 – 31 March 2019 Broader Management and Co-ordination Activities: • Provides leadership to local safety team, setting goals and operational guidance • Manages local staff and budget resources • Works with Regional safety leads on process improvement initiatives or implementation of legislative changes • Guides training and development activities for local safety staff • Participates in global/ regional /country safety meetings to share best practice • Provides input into cross functional programs, to reflect local requirements • Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by supervisor  Strategic Planning Activities: • Provides affiliate input to senior management planning of regional safety organization development, capacity management, resourcing and talent management initiatives  Activities as Local Safety Responsible Person:  Management of Core Safety Affiliate Responsibilities: Compliance Management: Pfizer İlaçları Ltd. Şti.: Country Safety Lead Feb 2010 – Nov 2011 Writing up and processing all initial and follow up adverse event reports (ICSRs). Ensuring that the received information meets the minimum requirements and reporting criteria of AE. Receiving and archiving all CIOMS reports. Entering data reports into global AEM database adhering to the time frames specified. Filing the initial and follow up reports into centralized AEM Report Files which are classified according to product types. Responding to global follow up queries regarding clinical trial originated cases. Providing training on adverse event reporting responsibilities to all relevant employees within 2 months’ interval of their initial employment Keeping the related training records in both Safety Training Files as hard copy and Local Safety Training database electronically. Follow up of procedures & regulations related with adverse event monitoring. Participating in meetings / trainings related with drug safety and presenting relevant reports to the Medical Director. Searching and reviewing local country medical and scientific journals periodically in Turkish Medline, for serious expected/unexpected and non-serious expected/unexpected adverse events on all Pfizer drug marketed and reviewing them to assess the validity for reporting criteria and submitting to SRM and MoH as appropriate. Writing any safety related DDL for registered products according to local procedures. Training the relevant personnel for the literature screening process. Receiving Local Product Documents, reviewing for drug safety information and forwarding to relevant Registration Specialist. Forwarding immediately to appropriate PCO Drug Safety Unit (DSU) any report received locally where the reporter’s country is not local country. Maintaining invalid reports (e.g., reports that do not meet the minimum criteria for valid reports) locally in a retrievable format. PCO DSUs will coordinate with local Clinical teams PharmaSwiss İlaç Tic. Ltd. Şti.: Regulatory Affairs and Pharmacovigilance Supervisor Mar 2009 – Dec 2009 Regulatory Affairs and Pharmacovigilance •preparing application dossiers in CTD format •preparing adverse event forms •pursuing pharmacovigilance duties according to Turkish regulations •preparing the application dossier for food supplements •Preparing MA transfer dossiers - Market Access for Business Development Comparative •Regulatory reimbursement guidance •Indication review / Rx data •Pricing review •Reimbursement review for cardiology, oncology, osteoarthritis, dermatology, eye care, medical devices, cosmetology - Visiting MoH and MoA - Managing MoH Representative in Ankara Fresenius Kabi İlaç Tic. Ltd. Şti.: Regulatory Affairs and Pharmacovigilance Specialist  Jul 2006 – Mar 2009 •calculating the prices of the products •preparing leaflets and PILs of the products. •preparing application dossiers in CTD format •preparing PSURs, adverse event forms •preparing documents for the enteral nutrition products’ applications Fresenius Kabi İlaç Tic. Ltd. Şti.: Regulatory Affairs and Pharmacovigilance Specialist    Jun 2003 – Jun 2009 • to study about the bioequivalence studies of the products • to work with planning department to calculate the prices of the products • preparing leaflets of the products. • preparing application dossiers in CTD format • preparing PSURs, adverse event forms EDUCATION • Marmara University, MBA, 2003-2004 • Marmara University, Bachelor, Faculty of Pharmacy, 1998-2003