Tina Nguyen
Director, Global Risk Management & Safety Surveillance, Scientist @Incyte
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WORK HISTORY
Director, Global Risk Management & Safety Surveillance, Scientist @Incyte
Manage and provide leadership to a Scientist team to produce deliverables in compliance with current employment guidelines and policies while assuring that all company procedures and global regulations for quality and timeliness are met for all deliverables- Oversee and provide support to Scientists within the risk management safety governance system to ensure positive benefit/risk profiles of medicinal products- Ensure processes allow for appropriate risk management planning and execution throughout a medicinal product’s lifecycle- Responsible for assigned products and oversee and provide support to Scientist within the drug safety signal detection processes for investigational and marketed products; endorse medically reasonable evaluations of safety signals; and make specific, actionable and defensible recommendations for confirmation or refutation of safety signals- Provide support to the Safety Physicians on the formulation of clinical trial and postmarketing risk management safety strategies that are in alignment with the company\'s drug development and commercialization strategies- Contribute to preparedness for regulatory authority inspections of Pharmacovigilance; contribute to the development and implementation of preventative and/or corrective action plans pertaining to identified deficiencies of policy, procedure, or practice- Participate in the process management, review and preparation of DSURs for Incyte clinical trial programs, and PADERs/PAERs and/or PBRERs and RMPs as warranted for marketed products- Key contributor in the review and preparation of ISS, CO, SCS, CSR, patient narratives, RMPs and other registration documents for new and supplemental drug submissions in the US and ex-US in conjunction with Clinical Development, Medical Writing, Statistics, and Regulatory Affairs- Participate in the process management, review and preparation of RSI for Incyte products, including IBs and marketed product labels (e.g. USPI, SmPCs, CCDS).
EDUCATION
Albany College of Pharmacy and Health Sciences
Doctor of Pharmacy (PharmD), Pharmacy
SKILLS
ABOUT TINA NGUYEN
Pharmaceutical professional with over 11 years of experience in Pharmacovigilance and Risk Management working across a variety of indications (mainly Oncology) and phases of development (Phase 1-3 as well as post-marketing).KEY SKILLS• Excellent written and verbal communication skills.• Ability to build strong relationships with colleagues and healthcare professionals.• Proven interpersonal skills, organization skills, and analytical thinking.• Ability to establish work priorities and directions independently.• Ability to adapt to rapidly changing needs and demands.• Embrace new ways of working, streamlining processes and improving workflows.• Knowledge of scientific terms and medical terminology.• Understanding of FDA and international regulations.• Knowledge of MedDRA coding dictionaries.• Proficient in Microsoft Office.
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