"Are you a highly experienced medical professional with a passion for ensuring the safety and efficacy of immunology treatments? Do you have a strong background in pharmacovigilance and risk management? Johnson & Johnson is seeking a dynamic and driven individual to join our team as the Director, Medical Safety Officer for our Immunology division. This role is critical in ensuring the safety and well-being of patients who rely on our life-changing immunology therapies. Join us in our mission to make a difference in the lives of patients worldwide. Qualified candidates will have a medical degree, extensive experience in pharmacovigilance and risk management, and strong leadership skills. If you are ready to take on this impactful and rewarding role, we encourage you to apply."
Develop and implement medical safety strategies and policies for the Immunology division in accordance with regulatory requirements and company standards.
Oversee and manage all aspects of pharmacovigilance and risk management activities for immunology treatments, including signal detection, evaluation, and management.
Lead and provide direction to the medical safety team, ensuring effective collaboration and communication within the team and with other departments.
Monitor and analyze safety data from clinical trials, post-marketing surveillance, and other sources to identify potential safety issues and develop risk mitigation strategies.
Serve as the primary medical safety expert and point of contact for regulatory agencies, providing timely and accurate responses to safety inquiries and submissions.
Collaborate with cross-functional teams to ensure integration of medical safety considerations into drug development, including clinical trial design, product labeling, and risk management plans.
Conduct thorough and timely evaluations of adverse events, product complaints, and other safety issues, and communicate findings to relevant stakeholders.
Stay current on industry trends, regulations, and best practices related to medical safety and pharmacovigilance, and apply knowledge to continuously improve processes and procedures.
Represent the company at scientific conferences and meetings to discuss safety-related topics and present data.
Support the development and review of safety sections of regulatory submissions and other relevant documents.
Ensure compliance with all applicable laws, regulations, and company policies related to medical safety and pharmacovigilance.
Foster a culture of patient safety and continuous improvement within the medical safety team and throughout the organization.
Mentor and develop team members, providing ongoing support, feedback, and opportunities for growth and development.
Collaborate with key stakeholders, such as clinical development, regulatory affairs, and commercial teams, to ensure alignment and integration of medical safety goals and strategies.
Act as a key liaison between the company and external partners, such as contract research organizations and other vendors, for medical safety-related activities.
Johnson & Johnson is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.