Tuba Nihan Doruk

Experience

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  GlaxoSmithKline

  Jul 2010 - Jun 2011

  Medical Affairs and Pharmacovigilance Traineeship Program
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  MUPSA (Marmara University Parmaceutical Students' Association)

  Sept 2010 - Jun 2012

  Co-Founder, President
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  Abdi Ibrahim Pharmaceuticals

  Apr 2012 - Jan 2015

  Pharmacovigilance Specialist

  Deputy QPPV for all PV activities in Turkey for active 200+ products (generic and original)• Authoring and management of communications with Regulatory Authority • Development and maintenance of Standard Operating Procedures • Case Management and Processing (Developed a Case Management Tool (QMex): database and workflow management tool for case processing)• Authoring and submission of PSURs for generic products• Coordination of pharmacovigilance audits and inspections (hosted 4 external audits from international Collaborating Companies)• Providing pharmacovigilance trainings companywide (1500+ employees) Show less

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  Abdi İbrahim Otsuka İlaç

  Jan 2015 - May 2017

  Pharmacovigilance Supervisor, QPPV

  Sole PV responsible person for all pharmacovigilance activities reporting directly to Managing Director. Structured in-house PV department and Quality Assurance and Medical Information systems in a newly established company. Lead a complex and multi-parties involved product transfer project successfully for 2 new territories.• Risk Management: Generated a Risk Management Plan (RMP) for a product at pre-authorized phase and implemented successful implementation of the additional risk minimization measures to the market – lead all communications with Health Authority. • Clinical Trials: Developed a Safety Management Plan (SMP) for an interventional clinical trial and contributed all phases from protocol preparation to the final publication from PV site. • Vendor Management: Oversight of all outsourced activities to PV Vendor and third parties for sub-licensed products• Quality Assurance: Served as QA responsible managing product quality complaints and recall.• Audit and Inspection Management: Managed Turkish Health Authority GvP inspection and various internal audits successfully. • Trainings: Provided pharmacovigilance trainings companywide and monitored its compliance and effectiveness – demonstrated an increased awareness across the company. • Contract Management: Responsible for management, oversight and compliance of Safety Data Exchange Agreements (SDEAs) and Quality Agreements with Business Partners• Budget Management: Managed department budget cost-effectively. Show less

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  Otsuka Pharmaceutical Companies Europe

  Jun 2017 - Sept 2022

  Global Lead for GPV CAPA and Deviation Management; Member of Global Audit and Inspection Readiness Team• Responsible for management and oversight of deviations and responses to findings from audits and inspections to ensure any non-compliance are identified and addressed including assessment of the root cause analysis. • Management of resource internal and external (vendor) a team of 12+ people cost-effectively.• Generate and monitor compliance metrics and perform trend analysis for internal/external audits and inspections.• Designed an interactive training model to ensure audit and inspection readiness at all times.• Collaborate with all other GPV groups and PV stakeolders and lead various continuous improvement activities and implementation of corrective measures. Show less

  • Associate Director, Global Pharmacovigilance Compliance and Business Management

    Jan 2021 - Sept 2022

  • Senior Manager, Global Pharmacovigilance Compliance and Business Management

    May 2020 - Jan 2021

  • Senior Manager, Global Pharmacovigilance Compliance and Business Management

    Jun 2017 - May 2020
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  Kyowa Kirin International plc.

  Sept 2022 - now

  Director, Global Affiliate PV Office