Patient Safety Physician
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Job Description
Drug Safety Physician supporting Parexel’s global pharmacovigilance and clinical research programs. Reviewing adverse events, monitoring safety signals, and supporting regulatory compliance.
Responsibilities:
- Perform medical review of spontaneous, clinical trial, literature, and combination product adverse event cases
- Assess seriousness, expectedness, listedness, causality, and overall medical relevance of reported safety events
- Review narratives, medical coding, source documentation, and case content for medical accuracy and consistency
- Provide medical guidance and support to pharmacovigilance and safety operations teams during case processing
- Support medical monitoring through review of adverse events, patient profiles, laboratory data, vital signs, medical history, and concomitant medications
- Provide medical and scientific input to internal teams, clients, investigators, and study personnel under appropriate supervision
- Review scientific and medical literature for product safety assessments and potential safety concerns
- Participate in internal and external meetings and present safety-related information
- Maintain awareness of global drug safety regulations, reporting obligations, and pharmacovigilance requirements
- Collaborate with stakeholders to address safety-related issues and support project objectives
Requirements:
- Bachelor of Medicine, Bachelor of Surgery (MBBS), Doctor of Medicine (MD), or equivalent medical qualification from an accredited medical school
- Completion of basic clinical medicine training, including residency, internship, or equivalent
- Fresher or relevant experience in pharmacovigilance, drug safety, clinical practice, or medical data review activities
- Knowledge of medical terminology and clinical assessment principles
- Understanding of ICH-GCP, GVP, global drug safety regulations, and applicable pharmacovigilance guidelines
- Strong communication, organization, analytical, and problem-solving skills
- Computer proficiency, including experience with Microsoft Office applications and web-based systems
- Experience working in clinical medicine, pharmacovigilance, clinical research, or a regulated healthcare environment
- Comfort working with safety databases, web-based applications, Microsoft Office tools, and pharmacovigilance processes
Benefits:
- Continuous learning opportunities
- Diverse teams and growth-oriented environment
- Remote work arrangement
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