This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an Associate Director, Medical Safety Review Physician based in Brazil.
This is a highly impactful opportunity for an experienced physician with deep expertise in pharmacovigilance and drug safety. In this role, you will provide medical leadership in the review and assessment of safety data across both marketed products and clinical development programs. Working at the intersection of clinical medicine, regulatory compliance, and patient safety, you will contribute to the identification, evaluation, and management of potential safety risks. You will collaborate closely with global cross-functional teams while supporting critical safety operations, regulatory submissions, and continuous process improvements. The position offers a dynamic and collaborative environment focused on scientific excellence, operational quality, and improving outcomes for patients worldwide.
Accountabilities:
- Serve as the medical safety expert responsible for reviewing and assessing Individual Case Safety Reports (ICSRs) originating from clinical trials, literature sources, post-marketing studies, and spontaneous adverse event reports.
- Evaluate adverse events and serious adverse events for accuracy, completeness, seriousness, expectedness, coding quality, and medical relevance.
- Perform causality assessments and provide expert medical judgment aligned with global pharmacovigilance standards and regulatory requirements.
- Review case narratives, identify missing clinical information, and issue medical safety queries to ensure comprehensive case evaluation.
- Detect potential safety signals at the individual case level and escalate critical findings to relevant safety leadership teams.
- Contribute to safety analyses, regulatory responses, aggregate safety reports, and submissions to health authorities and ethics committees.
- Support quality assurance initiatives through case review feedback, root cause investigations, compliance monitoring, and process optimization.
- Participate in audits, inspections, vendor oversight activities, and the development of pharmacovigilance procedures and standards.
- Deliver training and mentorship to medical review personnel and represent the medical safety function in cross-functional projects and initiatives.
- Drive continuous improvement efforts to enhance efficiency, compliance, quality, and operational excellence within safety review processes.
Requirements
- Medical degree (MD, DO, MBBS, or international equivalent).
- Significant experience in pharmacovigilance, drug safety, or medical safety review within the pharmaceutical, biotechnology, or life sciences industry.
- Prior experience performing medical review of ICSRs and evaluating adverse event reports across clinical development and post-marketing environments.
- Strong understanding of global pharmacovigilance regulations, safety reporting requirements, and signal detection methodologies.
- Experience assessing event seriousness, expectedness, causality, and medical significance using standardized safety frameworks.
- Familiarity with MedDRA coding practices and safety databases such as ARGUS.
- Preferred background in oncology, hematology, or related therapeutic areas.
- Excellent analytical thinking, clinical judgment, and problem-solving capabilities.
- Strong written and verbal communication skills, with the ability to present complex medical information clearly and effectively.
- Ability to work independently in a remote, global, and cross-functional environment while managing multiple priorities and deadlines.
- Proficiency in Microsoft Office applications and strong documentation skills.
- Fluent English communication skills are required.
Benefits
- Fully remote position based in Brazil.
- Opportunity to contribute to innovative therapies and programs that support patients globally.
- Exposure to international teams and global pharmacovigilance operations.
- Collaborative, science-driven, and mission-focused work environment.
- Professional development and continuous learning opportunities.
- Participation in cross-functional strategic initiatives and high-impact projects.
- Flexible work environment with limited travel requirements.
- Comprehensive benefits package and competitive compensation, aligned with experience and local market practices.
- Inclusive workplace committed to diversity, equity, and professional growth.