VERA SARKODIE
Middletown
Summary
Pharmacovigilance leader with over 10 years of experience in clinical research, drug safety, and pharmacovigilance within academic, pharmaceutical, and biotechnology sectors. Expertise in developing global pharmacovigilance strategies, signal detection, and regulatory compliance for oncology programs. Proven ability to collaborate with senior clinical leaders to integrate safety science into development processes, ensuring adherence to FDA and international regulations. Recognized for building effective safety organizations that prioritize patient outcomes in dynamic oncology environments.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Senior Medical Director, Global Drug Safety & Medical Monitoring
Cartesian Therapeutics
Frederick
12.2024 - Current
- Provide global, enterprise-level pharmacovigilance leadership for a multi-asset RNA-based cell therapy portfolio across Phase 1–3 clinical development, with accountability for safety strategy, governance, and execution.
- Act as the senior safety partner to the CMO and Clinical Development leadership, integrating safety science into clinical development strategy, dose escalation decisions, protocol design, and program risk tolerance.
- Execute end-to-end signal detection and signal management strategy, evaluating emerging safety trends, conducting cumulative analyses, and performing benefit–risk assessments across programs.
- Prepare and presented periodic benefit–risk evaluations to internal governance committees and executive leadership, ensuring informed decision-making.
- Act as the company’s medical safety authority in interactions with FDA and global health authorities, including written responses, briefing materials, and safety strategy discussions.
- Represent Global Pharmacovigilance in DSMB / Safety Monitoring Committee engagements, ensuring clear interpretation of safety data and actionable recommendations.
- Act as SME author, reviewer, and approver for DSURs, Investigator Brochures, IND annual reports, RMPs, REMS, protocols, ICFs, and other safety-related regulatory and clinical documents.
- Oversee pharmacovigilance systems, SOPs, and performance metrics in collaboration with Quality, ensuring inspection readiness and scalability for late-stage development and future commercialization.
- Build, mentor, and lead safety physicians and scientists, fostering a high-performing, patient-centered safety organization.
- Direct strategic collaboration with CROs, vendors, and external partners for case processing, safety reporting, and analytics, enhancing operational effectiveness.
Patient Safety Physician, Oncology & Immunotherapy
Gilead Sciences
07.2023 - 11.2024
- Led a senior safety science team supporting global oncology and immunotherapy programs across investigational and marketed products.
- Led signal detection, evaluation, and risk characterization, translating complex safety data into clear benefit–risk positions for internal governance and regulatory engagement.
- Authored and reviewed safety sections for IND, NDA, and BLA submissions, ensuring compliance and clarity in ISS, ISE, labeling, IBs, and CSRs.
- Represented Patient Safety in FDA, EMA, and global authority interactions, supporting responses to safety inquiries and inspection readiness.
- Collaborated with Clinical Development, Regulatory Affairs, Biometrics, and Clinical Operations to align safety strategy with program objectives.
- Developed and maintained RMPs, REMS, DSURs, and PSURs to enhance patient safety and regulatory compliance.
- Provided medical oversight of ICSRs and aggregate safety analyses to ensure high-quality, compliant safety reporting.
- Managed contract negotiations
Senior Medical Director, Drug Safety & Medical Monitoring
Bristol Myers Squibb
02.2020 - 07.2023
- Acted as senior medical advisor to Safety Operations and Medical Monitoring teams, facilitating consistent, high-quality safety decision-making.
- Led global medical safety activities across multiple development programs, combining strategic oversight with hands-on execution.
- Reviewed and approved SAEs, SARs, and SUSARs, ensuring compliance with seriousness, causality, listedness, and regulatory requirements.
- Directed preparation of DSURs, aggregate safety reports, and regulatory submissions (INDs, NDAs, BLAs).
- Collaborated with Clinical Development, Regulatory Affairs, and PV Operations to establish safety governance models and escalation pathways.
- Supported PV system optimization, CRO oversight, and inspection readiness in a global matrix environment.
- Participated in portfolio-level safety strategy discussions and program governance forums to inform decision-making.
Attending Pediatrician & Clinical Investigator
TLC Pediatrics
Norwalk
07.2016 - 01.2020
- Balanced active clinical practice with role as a clinical investigator on IRB-approved research studies, enhancing integration of research and patient care.
- Performed safety assessments and adverse event reporting, ensuring compliance with institutional and regulatory requirements to safeguard patient welfare.
- Authored and reviewed informed consent and pediatric assent documents to facilitate ethical participation in research studies.
- Experience grounding safety leadership in real-world patient care, reinforcing patient-first decision-making.
Education
Doctor of Medicine (MD) -
Albert Einstein College of Medicine
Bronx, NYPediatrics Residency -
Yale New Haven Children’s Hospital
New Haven, CTBS - Biology (Honors)
Syracuse University
Syracuse, NYSkills
- Pharmacovigilance
- Signal detection
- Risk assessment
- Risk management
- Regulatory compliance
- Data analysis
- Trial design
Technical And Systems Experience
- Safety Databases & PV Systems (enterprise & CRO-managed)
- Signal Detection Methodologies
- Global Regulatory Reporting Standards
- Vendor Oversight & Quality Collaboration
Training
- ICH-GCP (NIH)
- WHO Signal Detection & MedDRA Coding
- Global Health Fellowship — Ghana Sickle Cell Foundation
Core Leadership Expertise
- Global Pharmacovigilance Strategy & Governance
- Oncology Safety Science (Early → Late Phase)
- Signal Detection & Benefit–Risk Evaluation
- DSMB / Safety Committee Leadership
- FDA & Global Health Authority Engagement
- Aggregate Reporting (DSUR, ISS, ISE, RMP, REMS)
- Clinical Development Partnership
- CRO & Vendor Oversight / PV Systems
- Safety Organization Building & Mentorship
Certification
Board Certified Pediatrician (Active License)
Timeline
Senior Medical Director, Global Drug Safety & Medical Monitoring
Cartesian Therapeutics
12.2024 - Current
Patient Safety Physician, Oncology & Immunotherapy
Gilead Sciences
07.2023 - 11.2024
Senior Medical Director, Drug Safety & Medical Monitoring
Bristol Myers Squibb
02.2020 - 07.2023
Attending Pediatrician & Clinical Investigator
TLC Pediatrics
07.2016 - 01.2020
Doctor of Medicine (MD) -
Albert Einstein College of Medicine
Pediatrics Residency -
Yale New Haven Children’s Hospital
BS - Biology (Honors)
Syracuse University