Associate Director, Medical Safety Review Physician

About the role

This position offers a highly impactful opportunity for an experienced physician to lead medical safety review activities across marketed products and clinical development programs. Based in Brazil, you will work at the intersection of clinical medicine, regulatory compliance, and patient safety, supporting critical safety operations and continuous process improvements.

Key responsibilities

• Review and assess Individual Case Safety Reports (ICSRs) from clinical trials, literature, post‑marketing studies, and spontaneous reports.
• Evaluate adverse events for accuracy, seriousness, expectedness, coding quality, and medical relevance.
• Perform causality assessments and provide expert medical judgment aligned with global pharmacovigilance standards.
• Identify missing clinical information, issue safety queries, and ensure comprehensive case evaluation.
• Detect potential safety signals at the individual case level and escalate critical findings.
• Contribute to safety analyses, regulatory responses, aggregate safety reports, and submissions to health authorities.
• Support quality‑assurance initiatives, audits, inspections, vendor oversight, and development of pharmacovigilance procedures.
• Provide training, mentorship, and represent medical safety in cross‑functional projects.

Required profile

• Medical degree (MD, DO, MBBS or international equivalent).
• Significant experience in pharmacovigilance, drug safety, or medical safety review within pharma, biotech or life‑sciences.
• Proven experience performing medical review of ICSRs across clinical development and post‑marketing environments.
• Strong understanding of global pharmacovigilance regulations and safety reporting requirements.

Required skills

• Pharmacovigilance
• Drug safety
• Medical safety review
• Causality assessment
• Signal detection methodologies