Associate Director, Medical Safety Review Physician

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Deliver the medical and clinical expertise necessary to conduct medical reviews of Individual Case Safety Reports (ICSRs).

• Act as the safety medical expert to assess ICSRs for all company products, whether they are marketed or under clinical development.

• Conduct regular medical case reviews for all ICSRs reported from various sources, including clinical trials, literature, post-marketing studies, and spontaneous adverse event reports.

• Evaluate all Adverse Events (AEs) and Serious Adverse Events (SAEs) to determine if they are accurately reported and documented according to what occurred clinically in patients, while ensuring that events are correctly coded with MedDRA and that seriousness criteria are met.

• Assess the expectedness of AEs and SAEs for each event in accordance with Reference Safety Information (RSI) and guarantee consistent interpretation and application in ICSRs.

• Provide comprehensive case assessments and pharmacovigilance comments on ICSRs as required.

• Identify significant or critical cases that may indicate potential safety signals at the individual case level.

⛳️ Requirements

• MD, DO, MBBS, or an equivalent international qualification.

• Experience in medical case review and prior experience in the biopharmaceutical industry is preferred.

• A minimum of 2-4 years of clinical experience, inclusive of required training.

• Preferred minimum of 8-10 years of pharmacovigilance experience, including 2-3 years as a Medical Safety Review Physician; other MD experience in the pharmaceutical industry may also be considered.

• Exceptional communication skills (both verbal and written); strong and confident presentation abilities.

🏝️ Benefits

• Health insurance

• Paid time off