# Director / Associate Director, Global Patient Safety | Pharmacovigilance | Drug Safety Physician

Location Dallas, United StatesDesired Salary 100000 - 250000 USD/yearlyWork preference Remote Only / Full Time, Part Time, ContractLinks Joined8 Jul 2026Field / Industry Healthcare & Medical

* SharePreferences:Status: Actively lookingJob Level: SeniorRelocation: NoNotice Period: ImmediateCategory: Healthcare & MedicalSkill Assessments:This user has not passed any tests yet

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[Overview](#overview)

## About Me

Physician and Global Patient Safety leader with 11+ years of experience in pharmacovigilance, clinical safety, benefit-risk assessment, signal detection, aggregate reporting, and regulatory safety strategy across biotechnology and pharmaceutical organizations. Extensive experience supporting investigational and marketed products, including oncology and cell therapy programs. Expertise includes safety governance, signal management, aggregate reports, Risk Management Plans, health authority interactions, and cross-functional leadership.

## Skills

### [Oncology](https://jobicy.com/talent/oncology.md)[Regulatory Affairs](https://jobicy.com/talent/regulatory-affairs.md)[FDA](https://jobicy.com/talent/fda.md)[SOP Development](https://jobicy.com/talent/sop-development.md)[CAPA](https://jobicy.com/talent/capa.md)[Gene Therapy](https://jobicy.com/talent/gene-therapy.md)[Signal Detection](https://jobicy.com/talent/signal-detection.md)[Investigator Brochures](https://jobicy.com/talent/investigator-brochures.md)[Labeling Strategy](https://jobicy.com/talent/labeling-strategy.md)[PBRER)](https://jobicy.com/talent/pbrer.md)

## Education

Donetsk National Medical University, Ukraine  2014  Doctor of Medicine (MD)

## Experience

Medical Director, Global Patient Safety @ LEGEND BIOTECH  Apr 2025 - Present Lead global pharmacovigilance and patient safety activities supporting advanced therapy and clinical development programs. Provide medical oversight for safety surveillance, signal evaluation, aggregate reporting, and adverse event assessment. Partner with Clinical Development and Regulatory Affairs to execute product safety strategies throughout the lifecycle. Support inspections, audits, vendor oversight, and continuous process improvement initiatives. Manage department staffing, training, development, performance reviews, and staff meetings.

Medical Director, Global Patient Safety @ ALLOGENE THERAPEUTICS  Jan 2023 - Apr 2025 Directed global patient safety strategy for allogeneic cell therapy development programs. Chaired Safety Management Teams and led cross-functional signal detection and risk management activities. Authored and reviewed aggregate safety reports, regulatory responses, and core safety documents. Developed Risk Management Plans, Investigator Brochures, and product labeling content.

Medical Director, Safety Evaluation & Risk Management @ AXSOME THERAPEUTICS  Feb 2019 - Dec 2022 Led signal detection, safety trend analysis, and benefit-risk evaluations across development and marketed products. Performed medical review of SAEs, narratives, and safety datasets supporting regulatory decisions. Supported REMS, RMPs, labeling updates, SOP development, CAPAs, and inspection readiness. Organized and prepared safety data for quarterly Safety Management Team meetings and drafted meeting minutes.

Drug Safety Medical Reviewer @ GLOBAL BLOOD THERAPEUTICS  Mar 2017 - Dec 2018 Conducted medical review of safety cases for investigational and marketed products. Authored and reviewed DSURs, PBRERs, PSURs, and PADERs. Contributed to safety signal evaluation, benefit-risk assessments, and global regulatory compliance.

Medical Officer @ CENTRAL HOSPITAL WARRI, NIGERIA  Nov 2014 - Dec 2016 Provided inpatient, outpatient, and emergency medical care while maintaining high standards of patient safety.