Associate Director, Medical Safety Review Physician

BeOne Medicines

Medical Safety Review Physician conducting medical reviews of Individual Case Safety Reports at BeOne. Collaborating with teams to ensure compliance and safety signal detection.

Posted 6/14/2026full-timeRemote • 🇧🇷 BrazilSeniorWebsite

About the role

Key responsibilities & impact

Provide the medical and clinical expertise needed to perform medical review of Individual Case Safety Report (ICSR)
Serve as safety medical expert to evaluate ICSRs for all company products either marketed or in clinical development
Perform regular medical case review for all ICSRs reported from any source including clinical trials, literature, post-marketing studies and post-marketing spontaneous adverse event reports
Review all AEs and SAEs and determine whether the events are accurately reported and captured as what occurred in patient clinically and confirm that events are correctly coded with MedDRA and confirm seriousness criteria
Assess AE and SAE expectedness for each event per Reference Safety Information (RSI) and ensure correct, consistent interpretation and application to ICSRs
Provide overall case assessment and pharmacovigilance comments on ICSRs as needed
Identify important/critical cases with potential safety signals at single case level

Requirements

What you’ll need

MD, DO or MBBS or other international equivalent
Medical case review experience and prior biopharmaceutical industry experience preferred
Minimum of 2- 4 years Clinical experience, included training required
Minimum of 8-10 years pharmacovigilance experience preferred, including 2-3 years as a Medical Safety Review Physician is preferred; other MD experience in the pharmaceutical industry may be considered
Excellent communication skills (verbal and writing); Clear and confident presentation skills

Benefits

Comp & perks

Health insurance
Paid time off

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

medical reviewIndividual Case Safety Report (ICSR)adverse event (AE) assessmentserious adverse event (SAE) assessmentMedDRA codingReference Safety Information (RSI) interpretationpharmacovigilancecase assessment

Soft Skills

communication skillspresentation skills

Certifications

MDDOMBBS