Job Description: Chief Safety Officer (CSO)
Company Overview: At the Johnson & Johnson Medical Devices Companies, we have a rich history of over a century in improving surgical practices and healthcare solutions. Our commitment to advancing medical care globally drives us to develop innovative products and services. Safety Officer Jobs in Kuwait
As a leader in surgical technologies, orthopedics, and interventional solutions, we are shaping the future of health. We are currently seeking a highly qualified and motivated Chief Safety Officer (CSO) to join our team in Danvers, MA.
Position Summary: As the Chief Safety Officer, you will play a vital role in providing stewardship for medical device safety within our organization. While maintaining medical independence, you will collaborate with cross-functional teams to assess potential safety signals. Your expertise and leadership will be instrumental in executing the Medical Safety Organization’s strategy and implementing programs aligned with our Chief Medical Officer’s priorities. Building positive relationships with various departments, including R&D, Quality, Regulatory, Clinical, Epidemiology, and Safety sciences, will be crucial to establish a proactive and flexible risk management system.
Responsibilities: Safety Officer Jobs in Kuwait
- Risk Management: Assess product risk-benefit and provide medical input on Risk Management Reports, Health Hazards Evaluations, Clinical Evaluation Reports, and Product Safety Surveillance Plans (SSPs). Review and contribute to mitigations, labeling, safety training materials, adverse events, complaints, and mass communications.
- Safety Data Analysis: Interpret post-marketing safety data, aggregate complaint data, individual case safety reports, and scientific literature reports for potential safety issues.
- Study Support: Provide input into the design and interpretation of safety-related studies and evaluate results from SSP activities.
- Cross-functional Collaboration: Represent Medical Safety in product reviews during development, evaluate the medical impact of manufacturing and design issues, and provide oversight and guidance for product performance and medical safety.
- Monitoring and Trends: Monitor external sources for emerging issues, including complaint trends, regulatory intelligence, scientific publications, and market trends.
- Investigations and Customer Support: Advise on failure investigations, gather additional medical information from customers when required, and review safety-related information to prevent repeat adverse events and complaints.
- Stakeholder Engagement: Discuss adverse event investigations with healthcare professionals upon their request, participate in decision-making processes regarding field actions, and evaluate the effectiveness of field safety corrective actions.
- Process Alignment: Ensure consistency in medical evaluations, Quality Review Board decisions, safety evaluations, and deployment of standard practices.
- Metrics and Reporting: Establish appropriate metrics to assess patient safety-related processes and review and approve reports and filings from a medical safety perspective.
- Regulatory Compliance: Act as a subject-matter expert in audit and regulatory interactions, review and respond to safety-related inquiries from regulatory bodies, clinicians, and patients.
- Global Coordination: Collaborate with Regional Safety Officers to ensure timely information exchange and coordination.
Requirements: Safety Officer Jobs in Kuwait
- Medical degree (MD), Doctor of Osteopathy (DO), or equivalent.
- Minimum of 3 years of clinical or research experience.
- Relevant experience or specific training in a Cardiovascular specialty.
- Proficiency in common computer programs (Microsoft Office Outlook, Word, Excel, PowerPoint).
- Knowledge of basic statistical techniques and epidemiological principles.
- Preferred surgical specialties: Cardiac Surgery, Interventional Cardiology, Thoracic Surgery, or Cardiology.
- Experience in risk evaluation and mitigation.
- Experience in the medical device and/or pharmaceutical industry, preferably in healthcare and/or device industry.
- Clinical study/research experience.
- Experience working with senior leadership within a global healthcare company.
- Advanced statistical knowledge, such as multivariate data analysis.
- Familiarity with local and international Medical Device regulations.
At Johnson & Johnson, we are committed to diversity and equal opportunity. We value individuals of all backgrounds and ensure that no applicant is discriminated against based
