Senior Physician Patient Safety

Roles & Responsibilities
• Perform medical review, safety monitoring, and pharmacovigilance activities for assigned projects
• Act as Subject Matter Expert in assigned therapeutic areas and guide safety strategy
• Maintain expert knowledge of adverse event profiles, product labeling, and global safety regulations
• Ensure compliance with global regulatory timelines and internal SOPs for adverse event reporting
• Communicate and resolve review-related issues with project leads and stakeholders
• Participate in client, cross-functional, audit, and inspection meetings
• Provide inputs for process improvements and ensure achievement of process KPIs
• Function as pharmacovigilance representative and support bid defense activities
• Mentor and train Patient Safety Physicians and junior team members
• Perform expert medical review of complex clinical trial, spontaneous, and literature cases
• Assess seriousness, expectedness, causality, and medical coherence of safety cases
• Review narratives, source documents, and assign MedDRA coding
• Write MAH and pharmacovigilance comments and raise medical follow-up queries
• Review and author aggregate safety reports including PSURs, PBRERs, DSURs, SERs, COs, ACOs, and HHEs
• Provide medical monitoring support and sign off on adverse event reports
• Review data management listings to identify clinically meaningful trends
• Support preparation of clinical protocols, safety summaries, regulatory documents, and submissions
• Perform literature review for safety assessment and signal management
• Conduct signal detection, validation, evaluation, and author SERs
• Support risk management planning and maintenance of Risk Management Plans
• Review safety sections of CCDS, labels, and Development Core Safety Information
• Participate in safety committees, monitoring boards, and regulatory authority interactions
• Serve as Therapeutic Area expert and contribute to scientific forums and training initiatives

Qualification
• MBBS or MD from a recognized medical school

Experience
• Completion of basic clinical training such as internship or residency
• Relevant experience in pharmacovigilance, patient safety, or clinical practice
• Experience mentoring junior physicians preferred

Skills
• Strong expertise in pharmacovigilance, medical monitoring, and drug development
• Excellent clinical judgment and ability to assess medical data relevance
• Strong knowledge of global regulations including ICH GCP and GVP
• Proven leadership, mentoring, and stakeholder management skills
• Strong written, verbal, and presentation skills
• Ability to manage complex tasks and multiple priorities
• High attention to detail with strong analytical thinking
• Computer proficiency with safety databases and MS Office tools
• Flexible, collaborative, and client-focused approach

About the Company
Parexel is a leading global clinical research organization partnering with biopharmaceutical companies to accelerate the development and delivery of innovative medicines. With deep expertise in pharmacovigilance, medical sciences, and regulatory compliance, Parexel supports patient safety and scientific excellence across the entire product lifecycle.