Associate Medical Safety Director, Patient Safety

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.

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