A contact in our network has shared an opening for a Pharmacovigilance Case Evaluator (Case Operation) at a multinational pharmaceutical company. This permanent position, based in Osaka, Japan, offers a hybrid work model, blending remote flexibility with onsite presence. In this crucial role, you’ll evaluate safety reports, handle regulatory inquiries, and ensure strict compliance with Japanese regulations.

What’s the Job? Ensuring Drug Safety and Regulatory Compliance

As a Pharmacovigilance Case Evaluator, you will be on the front lines of drug safety, meticulously evaluating clinical and post-marketing safety reports to ensure the well-being of patients. Your responsibilities will span case evaluation, regulatory correspondence, and cross-functional collaboration.

• Evaluate Individual Case Safety Reports (ICSRs): You will be responsible for meticulously evaluating individual case safety reports (ICSRs) for both clinical trials and post-marketing surveillance. This involves assessing the reported adverse events, determining causality, and ensuring that all information is accurately captured and documented in accordance with regulatory standards. Your diligence in this area is paramount to patient safety and regulatory compliance.
• Review Literature and Identify Safety Concerns: You’ll actively review scientific literature and society information to proactively identify emerging safety concerns related to the company’s pharmaceutical products. This involves staying up-to-date with new research, clinical findings, and public health data to detect potential safety signals and contribute to the overall risk-benefit assessment of the products.
• Conduct Follow-up Investigations: You will conduct comprehensive follow-up investigations to gather additional safety information on reported cases. This involves liaising with healthcare professionals, patients, and other relevant parties to obtain a complete and accurate understanding of adverse events. Your investigative work ensures that safety reports are as complete as possible for regulatory submission.
• Handle Regulatory Authority Inquiries and Audits: You will serve as a key point of contact for the company, ready to handle regulatory authority inquiries, re-examinations, and audits. This requires a deep understanding of Japanese regulations and the ability to provide clear, accurate, and timely responses to questions from regulatory bodies, demonstrating the company’s commitment to compliance and transparency.
• Exchange Safety Information with Partner Companies and Manage Outsourcing: You will manage the secure and efficient exchange of safety information with partner companies. This ensures that all parties involved in the clinical development or marketing of a product have a consistent and complete safety profile. Additionally, you will be involved in managing outsourcing of certain pharmacovigilance activities, overseeing external partners to ensure they adhere to the company’s quality and compliance standards.
• Support Risk Management and Participate in Safety Projects: You will actively support risk management activities by contributing to the development and implementation of risk mitigation strategies for pharmaceutical products. You will also participate in various safety-related projects, such as system upgrades, process improvements, or new regulatory initiatives, contributing your expertise to enhance the overall pharmacovigilance function.

What’s Needed? Your Qualifications for Pharmacovigilance Excellence

To excel as a Pharmacovigilance Case Evaluator, you’ll need a strong medical/pharmaceutical background, extensive pharmacovigilance experience, and a deep understanding of Japanese regulatory compliance.

• Educational Background: A Bachelor’s degree or equivalent in medical/pharmaceutical sciences is required. This provides the essential foundational knowledge of medical terminology, drug mechanisms, and disease states, which is crucial for evaluating safety reports accurately.
• Extensive Pharmacovigilance Experience (3+ years): You must have more than 3 years of verifiable pharmacovigilance experience gained in a domestic or global pharmaceutical company. This extensive background indicates a seasoned professional capable of handling the complexities of drug safety reporting and compliance.
• Experience in Case Evaluation (3+ years): You must have more than 3 years of hands-on experience in case evaluation. This demonstrates your practical ability to assess ICSRs, determine causality, and ensure the accuracy and completeness of safety reports for regulatory submission.
• Practical Experience with Japanese Regulations: You possess practical, hands-on experience in compliance with Japanese regulations. This is a mandatory requirement, indicating your deep familiarity with the regulatory landscape in Japan, including the Pharmaceuticals and Medical Devices Act (PMDA) and other relevant guidelines.
• Prior Experience with PV Regulations and Guidelines: You have proven experience with pharmacovigilance (PV) regulations and guidelines. This foundational knowledge ensures you can adhere to all legal requirements and industry best practices in drug safety.
• Interest in IT Systems and Databases: You possess a strong interest in IT systems and databases, indicating a willingness to work with pharmacovigilance software, case management systems, and other technical tools used for data entry, analysis, and reporting in the pharmacovigilance domain.
• Business Level English: Business level English is required for collaborating with the multinational organization’s global teams, communicating with partners, and working with international documentation.

About the Company: A Global Leader in Pharmaceutical Innovation

This multinational pharmaceutical organization, originating from Europe, is renowned for its research and development of several widely recognized pharmaceutical products. In addition to its core pharmaceutical portfolio, the company also produces products related to diagnostic imaging, women’s health, and medical adhesives, showcasing a diverse and innovative approach to healthcare.