About

With 24 years of pharmaceutical and biotech experience, I am a pharmacovigilance consultant who provides support to companies in the areas of medical safety strategy, and global regulatory submissions.

I am the Principal of Han Consulting LLC, a firm that I founded in November 2023 to leverage my expertise and network in the field of pharmacovigilance.

I have led and overseen the pharmacovigilance activities and strategies for several novel products in a variety of therapeutic areas, both in large pharma companies (Pfizer, BMS, J&J) and in smaller biotech companies (SBE, HUTCHMED, a stealth startup).

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

I have also worked in China and Korea, as well as with colleagues in other regions, and I am proficient in Korean.

I am passionate about ensuring patient safety and delivering high-quality products that can improve lives.

Seong Won Han

Principal @ Han Consulting LLC

Experience

Oct 2022 - Oct 2023

Stealth Biotech Startup

SVP, Drug Safety Risk Management

Led safety portion of the Pre-IND meeting for the lead candidate.
Completed deep dive safety evaluations for all pipeline products in development.
Streamlined workflow with safety database vendor.
Drove development of several CDPs for the lead candidate.
Actively participated in evaluating future disease areas based on evolving MOA data.

Feb 2021 - Oct 2022

HUTCHMED

VP, Product Safety and Pharmacovigilance

Led the Product Safety and Pharmacovigilance activities and strategies for HMP International, in close collaboration with China headquarters.
Achieved simultaneous NDA & MAA submissions for surufatinib (lead product) and oversaw the conduct of the fruquintinib international Phase 3 study.

Apr 2019 - Dec 2020

Samsung Bioepis

VP, Medical & Lifecycle Safety Team Leader

Medical Team Leader responsible for ~90 staff with responsibility for clinical development, biometrics, pharmacovigilance and medical affairs teams, for all biosimilar products in the immunology, oncology, ophthalmology and hematology therapeutics areas.
Established medical affairs call center in Europe to support commercial partner (Biogen) with EU launches, and optimized oversight of and collaboration with PV vendor (IQVIA)

Sep 2016 - Nov 2018

Johnson & Johnson

VP, Head of International Pharmacovigilance

IPV Head responsible for ~200 colleagues working as LSOs in EMEA and AP regions across both Pharmaceutical and Consumer sectors.
Focus on local PV operational excellence, compliance and inspection readiness outside of the US.
Established regional cross-sector meetings focused on strengthening collaboration internally and with country and regional functions.
Member of the Global Medical Organization SLT.

Nov 2014 - Sep 2016

Johnson & Johnson

VP, China Cluster Safety Head & Interim AP Cross-sector Safety Lead

China Cluster Safety Head (a newly created role) with oversight of safety operational and medical oversight for China, Hong Kong and Taiwan, for pharmaceutical and consumer products.
Member of the Janssen China R&D SLT, the China Quality Safety Compliance Council and the Global Medical Organization SLT.
Additional responsibility as interim AP Cross-sector Safety Head, which included One South East Asia cluster, India, Aus/NZ and South Korea.
Member of the AP Medical Sciences LT and the global International PV LT.

Apr 2011 - Oct 2014

Johnson & Johnson

VP, Head of Medical Safety Assessment, Global Medical Safety

Global Head of all Safety Management Teams across all TAs, ensuring proactive safety evaluation of all development and marketed pharmaceutical products, and the management of the safety risks.
Supervised and gave strategic direction to six Therapeutic Area Safety Heads and their associated staff of medical safety officers, across the 3 major R&D sites (US, UK and Belgium).
Additional responsibilities include: Interim Head of PV Operations for 4 months & Interim Head of Established Products for 18 months.

Sep 2007 - Mar 2011

Bristol-Myers Squibb

Executive Director, Medical Safety Assessment TA Head

TA Head of a group of 8 MDs directly and 5 safety scientists indirectly, with responsibility for Medical Safety Teams.
Oversaw pharmacovigilance and safety risk management activities for all products in the Cardiovascular and Metabolics portfolio, and then for the Immunology and Oncology portfolio.
Ensured safety risk management strategy and implementation for assets in early & full development through lifecycle management for both dapagliflozin (in partnership with AZ) and apixaban (in partnership with Pfizer).

Jul 2004 - Sep 2007

Pfizer Ltd.

Senior Director, Regulatory Evaluation & Documentation TA Head

Set up a new HQ team of 20 physicians and scientists responsible for the clinical safety assessment and documentation for early assets, full development teams, CTD submissions and risk management strategy for products in the pain, inflammation, dermatology and ophthalmology therapeutic areas.
Learned the ropes on how to manage a team, including colleagues at another site.

Jun 2000 - Jul 2004

Pfizer Inc.

Director, Safety Risk Management Leader

Darifenacin Global Clinical Submissions Leader for overactive bladder, responsible for authoring the Module 2.5 Clinical Overview and overseeing the other Module 2.7 summary documents.
Following NDA and MAA approvals asset was divested. Pegaptanib Safety Risk Management Leader role within the company for wet AMD, with alliance partner, Eyetech.
Individual contributor with matrix management responsibilities for coordinating the safety submissions team, as well as mentoring of new staff.
High performance resulted in 2 promotions within 3 years of joining organization.Darifenacin Global Clinical Submissions Leader for overactive bladder, responsible for authoring the Module 2.5 Clinical Overview and overseeing the other Module 2.7 summary documents.
Following NDA and MAA approvals asset was divested.
Pegaptanib Safety Risk Management Leader role within the company for wet AMD, with alliance partner, Eyetech. Individual contributor with matrix management responsibilities for coordinating the safety submissions team, as well as mentoring of new staff.
High performance resulted in 2 promotions within 3 years of joining organization.

Contact

Let's discuss how I can meet your company's needs over a free 30-min Introductory Consultation.