Medical Director Pharmacovigilance Role

Sumitomo Pharma America, Inc. (SMPA) is seeking an Associate Medical Director for Pharmacovigilance and Risk Management to help drive innovative and patient-first solutions across key therapeutic areas. This critical role will contribute to the ongoing safety and risk management of both investigational and marketed products, ensuring compliance with global regulatory standards and promoting improved patient outcomes through advanced science and technology.

Job Overview

As Associate Medical Director, you will oversee continuous safety monitoring, risk/benefit assessment, and risk mitigation activities for a diverse portfolio, including oncology and rare diseases. You will play an integral part in clinical trial safety, regulatory submissions, and cross-functional collaboration, helping to advance SMPA’s mission of delivering technology-driven healthcare solutions.

Key Responsibilities

• Continuously monitor and assess risk/benefit profiles for assigned investigational and marketed products.
• Conduct safety surveillance throughout product life cycles, including clinical development and post-marketing phases.
• Generate and evaluate safety queries, author safety statements, and contribute to safety data analysis.
• Ensure timely medical review and assessment of Individual Case Safety Reports (ICSRs).
• Contribute to the development and execution of Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS).
• Represent Pharmacovigilance and Risk Management (PVRM) in study team meetings and governance committees.
• Participate in literature evaluation, investigator training, and regulatory audits.

Required Skills & Qualifications

• Medical Degree (MD) with 3-5 years of pharmaceutical drug safety experience.
• Advanced expertise in pharmacovigilance and risk management regulations (FDA, EU ICH).
• Proven experience in oncology is highly preferred.
• Strong skills in medical review of ICSRs and aggregate safety reports.
• Comprehensive knowledge of drug development and global regulatory requirements.
• Experience in expedited and periodic safety reporting, signal detection, and mitigation strategies.
• Strong cross-functional communication and leadership abilities.
• Eligibility for competitive benefits, including merit-based salary, incentive plans, and comprehensive health coverage.
• Ability to manage multiple priorities in a dynamic, technology-driven environment.
• Commitment to continuous learning and contributing to patient-focused healthcare innovations.