Summary
Overview
Work History
Education
Skills
Websites
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Work Availability
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Quote
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Seong Won Han

Seong Won Han

Princeton,NJ

Summary

24 years of pharmaceutical and biotech experience, providing support to companies in the areas of medical safety strategy, scientific safety assessment, and global regulatory submissions.

Principal of Han Consulting LLC, founded in November 2023 to leverage expertise and network in the field of drug safety and safety risk management.

Oversaw the pharmacovigilance activities and strategies for several novel products in a variety of therapeutic areas, both in large pharma and smaller biotech companies.

Expertise in preparing and submitting NDA and MAA summary documents, setting up and optimizing vendor oversight, and driving medical safety governance processes.

Experience working in China and Korea.

Overview

24
24
years of professional experience
1
1
Language

Work History

Principal

Han Consulting LLC
11.2023 - Current
  • Offering pharmacovigilance consulting services leveraging pharmaceutical and biotech experience.

Senior Vice President, Drug Safety Risk Management

Beren Therapeutics P.B.C.
10.2022 - 11.2023
  • Head of Drug Safety Risk Management, overseeing safety assessment reports and submissions. Led safety portion of pre-IND meeting for lead asset. Streamlined the SAE archiving process across programs. Drove CDP planning for 3 CV indications and 4 non-CV indications.

Vice President, Product Safety and Pharmacovigilance

HUTCHMED International Corp
02.2021 - 10.2022
  • Head of Product Safety and Pharmacovigilance, responsible for clinical trials and submissions. Led the safety submissions for NDA & MAA filings for lead asset (surufatinib). Oversaw the medical safety evaluation and medical monitoring for the global Ph3 asset (fruquintinib). Coached the PV team based in China on global PV requirements and processes.

Vice President, Medical Team Leader

Samsung BioEpis
04.2019 - 12.2020
  • Medical Team Leader, transforming the team into a global organization. Improved performance of the PV vendor (IQVIA). Established an EU call center to support the commercialization partner (Biogen). Streamlined Medical Affairs function.

Vice President, Head of International Pharmacovigilance

Janssen Research & Development
04.2011 - 11.2018
  • Head of International Pharmacovigilance, overseeing safety activities and risk management for all cross-sector local safety teams globally. Focused the regional interactions to drive communication and collaboration with local commercial teams.
  • Cross-Sector China Cluster Safety Head, overseeing safety operations and quality oversight for China, HK and TW. Strengthened local quality oversight mechanisms. Implemented continuous improvement approach across the newly unified local safety teams. Identified a successor.
  • Head of Medical Safety Assessment, overseeing Global Safety Officers across all J&J therapeutic areas and throughout product lifecycles. Responsible for all safety evaluations and escalations to the Chief Medical Officer.

Executive Director, TA Safety Head

Bristol-Myers Squibb Company
09.2007 - 04.2011
  • Therapeutic Area Safety Head, managing safety surveillance and risk management, for CV / Metabolism and then for Immunology / Oncology. Led the safety portion for the dapagliflozin FDA Advisory Committee, and subsequent NDA & MAA approvals. Operational chair for the Medical Review Group.

Senior Director, TA Head

Pfizer Inc
07.2004 - 09.2007
  • Therapeutic Area Head, overseeing safety writing activities and submissions for Pain, Inflammation and Dermatology. Supplemental NDA submissions completed for AROMASIN, LIPITOR, XANAX and CELEBREX.

Director, Risk Management Leader

Pfizer Ltd
06.2000 - 07.2004
  • Risk Management Leader, leading risk management strategy for a developmental asset (pegaptanib) for wet AMD.
  • Global Clinical Submissions Leader, leading the regulatory submissions for the NDA and MAA for darifenacin, a treatment for OAB.

Education

Doctor of Medicine (MD) -

University of Newcastle upon Tyne
Newcastle upon Tyne, UK
01.2004

Medicine & Surgery (MB ChB) & Registration with General Medical Council -

University of Glasgow
Glasgow, UK
01.1993

Intercalated BSc in Experimental Pathology -

University of Glasgow
Glasgow, UK
01.1990

Skills

  • Pharmacovigilance
  • Medical Safety Strategy
  • Safety Risk Management
  • NDA / MAA Submissions
  • Safety Data Analysis
  • Inspection Readiness
  • Vendor Operations Oversight

Languages

Korean
Professional Working

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Work Preference

Work Type

Contract WorkPart TimeFull Time

Work Location

RemoteHybrid

Quote

Either write something worth reading or do something worth writing.
Benjamin Franklin

Timeline

Principal

Han Consulting LLC
11.2023 - Current

Senior Vice President, Drug Safety Risk Management

Beren Therapeutics P.B.C.
10.2022 - 11.2023

Vice President, Product Safety and Pharmacovigilance

HUTCHMED International Corp
02.2021 - 10.2022

Vice President, Medical Team Leader

Samsung BioEpis
04.2019 - 12.2020

Vice President, Head of International Pharmacovigilance

Janssen Research & Development
04.2011 - 11.2018

Executive Director, TA Safety Head

Bristol-Myers Squibb Company
09.2007 - 04.2011

Senior Director, TA Head

Pfizer Inc
07.2004 - 09.2007

Director, Risk Management Leader

Pfizer Ltd
06.2000 - 07.2004

Doctor of Medicine (MD) -

University of Newcastle upon Tyne

Medicine & Surgery (MB ChB) & Registration with General Medical Council -

University of Glasgow

Intercalated BSc in Experimental Pathology -

University of Glasgow

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