Medical Safety Lead

📋 Description

• • Lead and provide strategic medical safety leadership, acting as the primary point of contact for all patient safety aspects across argenx products.
• • Define, drive, and implement the overarching strategy and approach for communicating critical safety information throughout the entire product lifecycle, from development to post-market surveillance.
• • Offer expert medical safety contributions and rigorous oversight, ensuring comprehensive ownership of all safety-related activities and initiatives.
• • Lead the meticulous assessment of safety data from diverse sources to support informed, data-driven decision-making for product safety profiles.
• • Foster and maintain close, collaborative relationships with key internal stakeholders, including Regulatory Affairs, Clinical Development, and Medical Affairs teams, to ensure seamless integration of safety strategies.
• • Engage effectively with external partners, such as Key Opinion Leaders (KOLs) and regulatory agencies, to align safety communications and uphold the safe and effective use of argenx's innovative therapies.
• • Contribute significantly to the development and execution of robust safety signal management processes, including the identification, assessment, and mitigation of potential safety signals.
• • Play a pivotal role in benefit-risk assessment activities, ensuring a balanced and comprehensive understanding of a product's safety profile in relation to its therapeutic benefits.
• • Lead and contribute to regular and ad-hoc aggregate safety data reviews, synthesizing information to identify trends and potential safety concerns.
• • Actively participate in and contribute to the establishment and refinement of the overall safety governance structure and associated activities, ensuring compliance and best practices.
• • Provide critical safety strategies and deliver accurate, timely, and high-quality safety contributions for the preparation of essential sections of global regulatory submission documents, such as Investigator's Brochures (IBs), Clinical Study Reports (CSRs), and responses to inquiries from regulatory authorities.
• • Ensure the completeness, accuracy, and high quality of safety sections within clinical documents, including study protocols, informed consent forms (ICFs), and other relevant clinical trial documentation.
• • Lead the comprehensive preparation of periodic safety reports, such as Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs), providing the medical safety content and ensuring overall consistency and quality.
• • Perform detailed medical assessments of Individual Case Safety Reports (ICSRs) when required, ensuring accurate interpretation and appropriate action.
• • Provide crucial medical safety contributions during internal audits and regulatory inspections, representing the company's commitment to safety compliance.
• • Support the development, maintenance, and implementation of Global Patient Safety (GPS) Standard Operating Procedures (SOPs) and other controlled documents, including work instructions, forms, and templates, to ensure standardized and efficient safety operations.
• • Contribute to product safety training and pharmacovigilance awareness activities across various functional teams, promoting a strong safety culture.
• • Lead the development, maintenance, and execution of Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS) to proactively manage and minimize identified risks associated with argenx products.
• • Contribute actively to the updates of safety labelling sections of product information and Core Data Sheets (CDS), ensuring accurate and up-to-date safety information is communicated.
• • Provide strategic guidance and maintain oversight of case processing activities, ensuring efficiency, accuracy, and compliance with regulatory requirements.
• • Partner closely with the Safety Operations team to address case quality issues, ensure appropriate MedDRA coding, and maintain consistent case processing conventions.
• • Participate actively in cross-functional projects and strategic initiatives, bringing a vital safety perspective to drive business objectives.
• • Manage and mentor safety physicians as required, fostering their professional development and ensuring high performance within the team.
• • Undertake other tasks as required to support departmental activities and contribute to the overall success of the Global Patient Safety function.
• • Drive a culture of continuous improvement within the patient safety function, identifying opportunities for process enhancements and efficiency gains.
• • Serve as a subject matter expert on patient safety and pharmacovigilance for internal and external stakeholders, providing clear and concise information.
• • Ensure compliance with all applicable global regulations, guidelines, and company policies related to pharmacovigilance and drug safety.
• • Contribute to the strategic planning for new product development from a safety perspective, identifying potential risks and mitigation strategies early in the development process.
• • Oversee the medical review of safety data from clinical trials, post-marketing studies, and spontaneous reports, ensuring timely and accurate assessment.
• • Collaborate with Medical Affairs to ensure safety information is effectively communicated to healthcare professionals and patients.
• • Support the development and implementation of pharmacovigilance agreements with third-party vendors and partners.
• • Ensure the integrity and quality of safety databases and reporting systems.
• • Act as a key contributor to the company's overall drug development and lifecycle management strategy through robust safety oversight.