Macka Barry
@mackabarry
Medical Safety Executive at EMD SERONO, providing oncology safety review and regulatory oversight for clinical and post-marketing portfolios.
United StatesWhat I'm looking for
At EMD SERONO, I provide medical review and authoritative causality assessments for oncology, immuno-oncology, and targeted therapy portfolios. I also review aggregate safety reports, including PBRERs and DSURs, and support updates to Investigator Brochures, Reference Safety Information, and Company Core Data Sheets.
Earlier at EMD SERONO, I reviewed serious, non-serious, and clinical trial ICSRs and co-created an electronic safety handbook for medical review and risk management. My clinical work includes coordinating Phase I and II immuno-oncology trials at CANCER INSTITUTE OF NEW JERSEY / RUTGERS and practicing as a urologist at IGNACE DEEN TEACHING HOSPITAL.
Experience
Work history, roles, and key accomplishments
Associate Medical Director, Medical Safety Advisor
EMD Serono
Mar 2020 - Present (6 years 7 months)
Serve as global Medical Review Subject Matter Expert for oncology and immuno-oncology assets, directing cross-functional safety strategies and authoring regulatory documents.
Drug Safety Scientist, Medical Assessment Team
EMD Serono
Nov 2018 - Mar 2020 (1 year 4 months)
Executed medical review of ICSRs across oncology portfolios, authored PV comments and AOSE, and co-created an electronic safety handbook.
Oncology Clinical Research Coordinator
Cancer Institute of New Jersey / Rutgers
Feb 2018 - Sep 2018 (7 months)
Coordinated Phase I and II immuno-oncology trials, managed study activation and data reconciliation, and authored SAE reports.
Oversaw triage, coding, and narrative writing for clinical trials and post-marketing portfolios using Argus, and provided medical guidance.
Senior Clinical Research Coordinator
MRHE Foundation Inc.
Jul 2012 - Aug 2015 (3 years 1 month)
Managed daily clinical trial activities, site SOPs, and TMF alignment, and directed patient screening and adverse event triage.
Drug Safety Associate & Clinical Scientist
Qtech Solution Inc.
Nov 2014 - May 2015 (6 months)
Conducted simulated pharmacovigilance reports and analyzed ICSR data trends for clinical trial portfolios.
Allied Health Instructor
Gee's Training Career Center
Jan 2012 - Jul 2012 (6 months)
Taught advanced anatomy, clinical physiology, and phlebotomy protocols to allied health professionals.
Clinical Research Associate Intern
Norton Auditing Inc
Jan 2012 - Apr 2012 (3 months)
Gained hands-on experience in clinical research monitoring, GCP/ICH, FDA regulations, and audit skills.
Directed surgical and medical workflows in the Department of Surgery and Maternity, leading a team of 26 healthcare professionals.
Physician ā Urologist & Research Coordinator
Ignace Deen Teaching Hospital
Dec 2004 - Jul 2007 (2 years 7 months)
Spearheaded surgical treatment for advanced oncology profiles and coordinated medical research theses and clinical data registers.
Education
Degrees, certifications, and relevant coursework
Quinnipiac University
Master of Science, Molecular and Cell Biology
Master of Science in Molecular and Cell Biology from Quinnipiac University.
Fudan University
Master of Science, Medicine/Surgery (Urology)
Master of Science in Medicine/Surgery (Urology) from Fudan University.
Shanghai Medical University
Doctor of Medicine, Medicine
Doctor of Medicine (MD) / Bachelor of Medicine & Surgery from Shanghai Medical University.
Association of Clinical Research Professionals (ACRP)
Certified Clinical Research Professional (CCRP), Clinical Research
Certified Clinical Research Professional (CCRP) certification from the Association of Clinical Research Professionals.
Vanderbilt University
Data Management for Clinical Research Certification, Data Management for Clinical Research
Data Management for Clinical Research Certification from Vanderbilt University via Coursera.
Qtech Solution Inc.
Drug Safety Associate / Pharmacovigilance Professional Certification, Pharmacovigilance
Drug Safety Associate / Pharmacovigilance Professional Certification from Qtech Solution Inc.
Norton Training Institute
Clinical Research Associate Certification, Clinical Research
Clinical Research Associate Certification from Norton Training Institute.
Tech stack
Software and tools used professionally
Availability
Location
United StatesAuthorized to work in
Salary expectations
Social media
Job categories
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