Associate Medical Safety Officer

Empresa Reconocida is seeking an Associate Medical Safety Officer to provide medical safety stewardship for Medical Device & Technology (MedTech) products.

Key Responsibilities:

• Assess product risk-benefit and offer medical input/review to Risk Management Reports, Product Issue assessment/Health Hazards Evaluations, Clinical Evaluation Reports, Product Safety Surveillance Plans (SSPs), including risk categorization of product/product families.
• Review and provide input on mitigations, labeling and internal and customer safety training materials directed to minimize patient risk and improve outcomes; adverse events, complaints and mass communications.
• Clinical interpretation of post-marketing safety data, aggregate complaint data, individual case safety reports, literature reports with possible safety data.
• Input into design and interpretation of safety-related studies, and results of any SSP activities.
• Represent Medical Safety in various product reviews during development.
• Evaluation of medical impact of manufacturing and design issues.
• Responsible for oversight and guidance as it relates to the performance and Medical Safety of products.
• Monitor external sources/trends and identify and call out emerging issues including (but not limited to) complaint & MDR/MDV trends, regulatory & market trends/intelligence, literature and scientific publications.
• Advise on failure investigations and provide medical opinion when deciding on reportability.
• Work with customers/users to gather additional medical information/data when required to support investigations.
• When required, review additional safety-related information to customers to prevent repeat adverse events and complaints.
• Discuss with healthcare professionals (at their request) AE investigations as well as discussion of AEs that the customer experienced.
• Be the medical representative within the review process when making decisions on field actions and help evaluate the effectiveness of field safety corrective actions.
• Ensure consistency in medical evaluations, Quality Review Board decisions and overall Safety evaluations of products.
• Deploy standard practices in coordination with MedTech CMO.
• Ensure appropriate metrics are used to assess adequacy of patient safety related processes.
• Contribute to and periodically review the definition of a product's harms and hazards list and derivations of criteria for reportability.
• Act as subject-matter-expert in audit and other regulatory body interactions.
• Review and approve (from a medical safety perspective) appropriate reports and filings.
• Review responses to regulatory bodies, clinicians and patients when safety issues are involved.
• Coordinate with Regional Safety Officers to ensure timely coordination of information.

Requirements:

• Doctor of Medicine (MD), Doctor of Osteopathy (DO), Physician Assistant, Nurse Practitioner or equivalent degree.
• Minimum of 3 years clinical or research experience preferably in a patient-facing setting.
• Relevant experience or specific training in a Cardiovascular specialty.
• Ability to use common computer programs (Microsoft Office Outlook, Word, Excel, PowerPoint).
• Knowledge of basic statistical techniques and epidemiological principles.
• Knowledge of pre-clinical or clinical research basic concepts.

Preferred Qualifications:

• Preferred experience specialties include Cardiology, Interventional Cardiology, Cardiovascular Surgery, Cardiac Failure & Transplant, Cardiac Critical Care, Cardiac Reperfusion.
• Experience in risk evaluation and mitigation.
• Medical device and/or pharmaceutical industry experience in Health Care and/or device industry.
• Clinical study/research experience.
• Experience of working with senior leadership within a global healthcare company.
• Advanced statistical knowledge (e.g., multivariate data analysis).
• Knowledge of local and international Medical Device regulations.