Duygu Yazar Toyran

• Successfully oversaw, coordinated and managed Patient Safety (PS) operational processes through leading 11-associate team (seven direct and three indirect reports) at Country Organization under Global Drug Development, and ensured compliance not only for Novartis Pharmaceuticals and Novartis Oncology but also Sandoz, Advanced Accelerator Applications and Novartis Gene Therapies marketed and investigational products (drugs, devices and combination products).
• Acted as National QPPV in Turkey and as Single Point of Contact with National Health Authority (NHA) on 24-hour basis.
• Designed, implemented and executed appropriate PV strategy through shaping PV Intelligence mindset at Country level.
• Identified opportunities with greatest impact and navigated challenges at intersection of PV insight, strategy, and innovation.
• Supported continuous improvement of PV intelligence and developed simplified or new standards, processes, mapping tools & templates for operational excellence along with translating processes and concepts, associated data, and insights into analytical frameworks and reports that characterize performance, inform business decisions.
• Managed all safety information, local literature screening, reconciliation activities and adverse event trainings at Country level.
• Established key relationships with both internal (particularly RA, QA and Compliance) and external (NHA) stakeholders to facilitate knowledge and best practices exchange.
• Gained experience in governance and oversight of Patient Oriented Programs (POPs) to meet quality & compliance and build trust with society.
• Maintained compliance and quality with appropriate issue escalation and resolution with execution of CAPAs to minimize compliance gaps.
• Contributed to Vendor Excellence for primarily outsourced PV activities.
• Effectively cooperated with RMP key stakeholders on implementation of RMP commitments, in particular additional risk minimization measures such as physician and patient educational materials and Dear Healthcare Professional Communication (DHPC) from PS perspective.
• Timely and successfully aligned with Global Line Functions/QPPV office in producing accurate and fit for purpose evaluation documents with clear conclusions in response to NHA requests for safety data and provided safety related strategic input into regulatory requests.
• Reviewed and assessed pre/post-authorization studies (inc. PASS) to ensure PV requirements are properly established, and worked closely with CROs and Country Trial Monitoring Organization to ensure design of local trials allow timely processing and regulatory compliance for all SAEs.
• Authored safety section of local clinical study protocols, concept sheets, study specification worksheets, and reviewed interim/final study reports.
• Proactively liaised with program owners (POPs / Social Media programs / Websites and other Digital Engagement Assets) and advised to ensure safety related appropriate mechanisms.
• Advised on vigilance provisions of licensing agreements and participated in due diligence activities by providing expert safety assessments.
• Smoothly led globally conducted self-inspection and PV audit achieving “good” outcome (no critical finding with one major three minor findings).

• Achieved acting as both National local Qualified Person for Pharmacovigilance (QPPV) and Country RMP Manager in Turkey for Novartis Group - both functional and operational.

• Had full oversight of RMP submissions to NHA along with driving local implementation of RMP commitments
• Provided input as required by Global RMP Office and EU QPPV on implementation (compliance) status of local RMP commitments.

• Processed cases for Novartis Oncology and Hematology products and submitted ICSRs to NHA
• Prepared or updated local Standard Operating Procedures (SOPs) when required and tracked their implementation.
• Tracked PS KPIs including monthly NHA submissions and global compliance monitoring results.
• Provided input, reviewed and approved market research programs conducted by business units for language, content and established necessary checks on collection and reporting of safety information.

• Managed collection, processing, reporting, submission and follow-up of all adverse event reports from various intake channels for Novartis Pharma products and interacted and exchanged relevant safety information with NHA, PS associates, other functional groups and third party contractors.
• Monitored national PV regulations in terms of updates
• Performed reconciliations with cross functions and third party contractors.
• Managed and maintained all relevant Patient Safety databases (Argus, Trackwise) and all POPs via POPsys.
• Ensured Root Cause Analysis (RCA), Delay Point Analysis (DPA) and preparation of CAPAs for delayed reports and submissions.
• Developed and updated training materials and ensured training of CO associates on PS procedures.

• Prepared SmPC /PIL as well as Non-Clinical Overview and Clinical Overview parts of product dossiers in accordance with current documents of reference products and EMA, FDA, EC, ICH Guidelines.
• Interpreted Bioavailability and Bioequivalence status of products of interest.
• Provided business advice on medical parts of product dossiers to various departments and responded to deficiency letters from government stakeholders in exporting countries in timely and accurate manner.
• Closely monitored international legislation and customer practices, particularly in exporting countries.