Associate Medical Safety Director, Patient Safety
TypeFull-time job
LocationSerbia
Posted3 hours ago
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
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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