Lead Medical Safety Oversight for Global Drug Development
Parexel is a leading global clinical research organization (CRO) dedicated to advancing medical breakthroughs. We are seeking an experienced Senior Patient Safety Physician to serve as a Subject Matter Expert (SME), providing critical medical safety oversight, complex case review, and mentorship. In this key remote role, you will apply your clinical expertise to ensure the integrity of safety data, guide pharmacovigilance strategy, and support the development of safe and effective therapies.
Your Key Accountabilities
Core Medical Review & Expertise:
- Perform in-depth medical review of complex individual case safety reports (ICSRs), including clinical trial, post-marketing, and literature cases, assessing causality, seriousness, and expectedness.
- Provide expert medical guidance to case processing teams, ensuring medical coherence and accuracy in narratives and regulatory responses.
- Write Pharmacovigilance/Marketing Authorization Holder (MAH) comments and apply expert clinical judgment to challenging cases.
Strategic Leadership & Mentorship:
- Act as a Subject Matter Expert (SME) within designated therapeutic areas, providing specialized knowledge to support drug safety initiatives and decision-making.
- Mentor and train junior Patient Safety Physicians, fostering their professional growth and expertise.
- Represent Parexel's medical expertise in client meetings, bid defenses, and scientific forums.
Safety Surveillance & Process Excellence:
- Maintain expert knowledge of assigned products' safety profiles, labeling, and global regulatory requirements (ICH GCP, GVP).
- Support literature surveillance for safety assessments and contribute to signal management activities.
- Provide medical guidance to Pharmacovigilance and study teams, including input for Data Monitoring Committees (DMCs) and Clinical Endpoint Committees (CECs).
- Contribute to process improvements and ensure adherence to Key Performance Indicators (KPIs).
Compliance & Collaboration:
- Ensure compliance with internal and regulatory timelines for adverse event reporting.
- Interact effectively with internal and external stakeholders to resolve complex safety issues.
- Support audits and inspections as a medical safety expert.
Your Profile: Qualifications & Experience
Education & Clinical Background:
- MBBS / MD degree from an acknowledged medical school.
- Completion of basic clinical training (residency, internship). Current or past clinical practice experience is highly valued.
Experience & Skills:
- Minimum of 2 years of direct experience in pharmacovigilance, drug safety, and medical monitoring within a pharmaceutical company or CRO.
- Strong knowledge of medical terminology, drug development processes, and international drug regulations (ICH GCP, GVP).
- Proven ability to exercise clinical judgment, interpret complex medical data, and assess clinical relevance.
- Excellent presentation, communication, and interpersonal skills, with a client-focused approach.
- Experience mentoring junior team members and working effectively in a matrix environment.
- Proficiency with Microsoft Office and web-based applications.
- Flexible, detail-oriented, and able to manage multiple priorities in a dynamic setting.
Why Join Parexel?
- Global Impact & Leadership: Act as the medical authority for drug safety on global development programs, with a direct influence on patient safety.
- Expert Development: Deepen your expertise as a therapeutic area subject matter expert in a leading global CRO.
- Remote Flexibility: Work from anywhere while collaborating with a worldwide team of safety and clinical experts.
- Career Advancement: Clear pathway for growth into therapeutic area leadership or senior medical director roles.
Ready to apply your clinical expertise to safeguard patient safety in global drug development?
Apply now for the Senior Patient Safety Physician position.
Parexel is an equal opportunity employer. We welcome applications from all qualified individuals.
