Associate Medical Safety Director, Patient Safety

🔥 1 minute ago

🇷🇸 Serbia – Remote

⏰ Full Time

🔴 Lead

👔 Director

👻 Ghost score 10%

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• 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 the medical safety function in client meetings, regulatory audits, and inspections • Lead signal detection and management activities with scientific rigor and regulatory compliance • Oversee signal validation and assessment of emerging safety concerns • Review and contribute to Signal Evaluation Reports and regulatory responses • Participate in Safety Management Team meetings and drive data analysis and informed decision-making • Mentor colleagues in signal detection methodologies and best practices • Oversee safety deliverables across assigned oncology projects • Provide quality governance and guidance on medical reviews, case assessments, and aggregate safety reports • Contribute to 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

🎯 Requirements

• Significant clinical or pharmacovigilance experience in oncology • Proven experience in signal detection, evaluation, and management within a regulated environment • Substantial background in drug safety, risk management, and global regulatory compliance (ICH GCP, GVP) • Strong medical background with the ability to exercise independent judgment on complex safety issues • Demonstrated success in audits, regulatory interactions, and cross-functional collaboration • 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 • Medical Degree: MBBS, MD, or equivalent from an accredited medical school • Completion of basic clinical training (residency, internship, or equivalent) • Proven expertise in global safety regulations and compliance standards

🏖️ Benefits

• Meaningful projects that directly impact patient safety and drug development