Patient Safety Physician

Roles & Responsibilities
• Perform medical review of safety cases including serious and non-serious spontaneous, clinical trial, and literature cases
• Maintain working knowledge of adverse event profiles, product labeling, and safety data for assigned products
• Assess seriousness, expectedness, causality, and medical coherence of reported adverse events
• Review narratives, source documents, and assign appropriate MedDRA coding
• Write pharmacovigilance and MAH comments and raise medical follow-up queries as required
• Provide medical input to case processing and safety teams under guidance
• Identify and resolve case-related issues in coordination with project teams and clients
• Answer day-to-day medical and scientific queries related to patient safety
• Review adverse event trends and provide medical interpretation of safety data
• Support medical monitoring activities and safety reporting requirements
• Review data management listings including AEs, labs, vitals, medical history, and concomitant medications
• Contribute medical input to clinical protocols, safety reports, and regulatory documents
• Perform literature review for product safety assessment and signal detection
• Provide medical guidance to pharmacovigilance and study teams
• Participate in internal and external meetings, trainings, and reviews under senior physician guidance
• Ensure compliance with global regulatory requirements, SOPs, and reporting timelines

Qualification
• MBBS, MD, or equivalent medical qualification from a recognized medical school

Experience
• Completion of basic clinical training such as internship or residency
• Experience in pharmacovigilance, drug safety, or medical data review preferred
• Clinical practice experience desirable

Skills
• Strong knowledge of medical terminology and clinical concepts
• Understanding of pharmacovigilance, drug safety, and clinical trial principles
• Familiarity with global regulations including ICH GCP and GVP
• Good written, verbal, and presentation skills
• Strong analytical and decision-making ability
• Ability to work within defined procedures and regulatory frameworks
• Computer proficiency with web-based systems and MS Office applications
• Flexibility, collaboration, and willingness to learn

About the Company
Parexel is a leading global clinical research organization that partners with biopharmaceutical companies to accelerate the development and delivery of innovative medicines. With deep expertise in clinical research, pharmacovigilance, and regulatory science, Parexel is committed to improving patient outcomes while maintaining the highest standards of scientific quality, compliance, and patient safety.