Associate Medical Safety Director, Patient Safety
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Job description
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Are you a physician with deep expertise in oncology and a passion for drug safety? We're seeking an experienced Associate Medical Safety Director to lead medical safety initiatives across our client’s oncology portfolio and drive strategic improvements in pharmacovigilance and risk management.
In this role, you'll combine clinical leadership with scientific expertise to ensure the highest standards of patient safety and regulatory compliance. You'll be at the forefront of complex safety decision-making and partnering with cross-functional teams and our client to advance our drug safety capabilities.
What You'll Do
Medical Leadership & Expertise
- Serve as a trusted medical authority on oncology product safety profiles, regulatory requirements, and global pharmacovigilance standards
- Provide expert medical judgment on complex safety issues, escalations, and critical assessments
- Represent our medical safety function in client meetings, regulatory audits, and inspections
Signal Detection & Management
- Lead signal detection and management activities with scientific rigor, ensuring compliance with regulatory requirements
- Provide expert oversight and guidance on signal validation and assessment, offering critical medical judgment on emerging safety concerns
- Review and contribute to Signal Evaluation Reports (SERs) and regulatory responses
- Participate in Safety Management Team meetings, driving data analysis and informed decision-making on high-priority oncology projects
- Mentor colleagues in signal detection methodologies and best practices
Safety Oversight & Governance
- Oversee safety deliverables across assigned oncology projects, ensuring compliance with internal processes and regulatory timelines
- Provide quality governance and expert guidance on complex medical reviews, case assessments, and aggregate safety reports
- Contribute to periodic safety reports (PBRERs, PSURs, DSURs) and regulatory submissions
- Support medical monitoring activities, including adverse event review and Data Monitoring Committee participation
- Act as the escalation point for unresolved safety issues, ensuring timely and scientifically sound resolution
Who You Are
Essential Experience:
- Oncology expertise – Significant clinical or pharmacovigilance experience in oncology is essential
- Signal management– Proven experience in signal detection, evaluation, and management within a regulated environment
- Pharmacovigilance leadership – Substantial background in drug safety, risk management, and global regulatory compliance (ICH GCP, GVP)
- Clinical excellence – Strong medical background with the ability to exercise independent judgment on complex safety issues
- Client-facing experience – Demonstrated success in audits, regulatory interactions, and cross-functional collaboration
Key Skills:
- Advanced clinical expertise with strong analytical and strategic thinking abilities
- Exceptional communication skills – able to present complex scientific concepts to diverse audiences
- Leadership capability, balancing technical responsibilities with people management
- Proficiency with pharmacovigilance systems, data analysis tools, and Microsoft Office
- Business acumen and understanding of financial implications of project decisions
- Adaptability and strong commitment to teamwork in a matrix environment
Qualifications
- Medical Degree: MBBS, MD, or equivalent from an accredited medical school
- Clinical Training: Completion of basic clinical training (residency, internship, or equivalent)
- Regulatory Knowledge: Proven expertise in global safety regulations and compliance standards
Why Join Us?
At Parexel, you'll work on meaningful projects that directly impact patient safety and drug development.
Originally posted on Himalayas
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