Associate Medical Safety Director, Patient Safety

This is a fully remote position, open to applicants in Serbia.

📋 Description

• Act as a reliable medical expert on oncology product safety profiles, regulatory mandates, and global pharmacovigilance standards.

• Deliver expert medical insights on intricate safety matters, escalations, and critical evaluations.

• Represent the medical safety division in client discussions, regulatory audits, and inspections.

• Lead signal detection and management initiatives with scientific precision and adherence to regulatory standards.

• Supervise the validation of signals and the evaluation of emerging safety issues.

• Review and contribute to Signal Evaluation Reports and responses to regulatory inquiries.

• Engage in Safety Management Team meetings, facilitating data analysis and informed decision-making.

• Mentor peers in signal detection techniques and best practices.

• Manage safety deliverables across designated oncology projects.

• Provide governance and guidance on medical evaluations, case reviews, and aggregate safety reports.

• Contribute to PBRERs, PSURs, DSURs, and submissions to regulatory bodies.

• Assist in medical monitoring tasks, including the review of adverse events and participation in Data Monitoring Committees.

• Serve as the escalation contact for unresolved safety concerns.

⛳️ Requirements

• Extensive clinical or pharmacovigilance experience in the field of oncology.

• Proven expertise in signal detection, assessment, and management within a regulated framework.

• Significant experience in drug safety, risk management, and global regulatory compliance (ICH GCP, GVP).

• Strong medical foundation with the capability to exercise independent judgment on complex safety matters.

• Demonstrated effectiveness in audits, regulatory engagements, and cross-functional teamwork.

• Advanced clinical knowledge coupled with strong analytical and strategic thinking skills.

• Outstanding communication abilities, capable of conveying complex scientific ideas to varied audiences.

• Leadership skills, effectively balancing technical responsibilities with team management.

• Proficiency in pharmacovigilance systems, data analysis tools, and Microsoft Office applications.

• Business insight and an understanding of the financial implications of project decisions.

• Flexibility and a strong dedication to collaboration in a matrixed environment.

• Medical Degree: MBBS, MD, or an equivalent qualification from an accredited medical institution.

• Completion of foundational clinical training (residency, internship, or equivalent).

• Established expertise in global safety regulations and compliance standards.

🏝️ Benefits

• Engaging projects that have a direct influence on patient safety and drug development.