Medical Safety Officer - Electrophysiology

Johnson & Johnson Innovative Medicine•Plymouth, MN

About The Position

Johnson & Johnson is currently seeking a Medical Safety officer to join our team located in Irvine, CA or Plymouth, MN. Description The Medical Safety Officer (MSO) role is to provide medical safety stewardship for Medical Device (MD) products. Although a medically independent voice is key, collaboration in assessing potential safety signals is expected. This individual is an active member of a diverse team, and a close partner with the quality leader and statistical colleagues, in assessing any potential safety signal for an MD product. They will execute on the Medical Safety Organization’s strategy, by implementing programs and leading in the strategic priority areas as defined by the Chief Medical Officer. The MSO will build clear and positive relationships between R&D, Quality, Regulatory, Clinical, Medical Affairs, Epidemiology and Safety sciences and Safety process and groups to allow for proactive and flexible risk management system. The MSO is knowledgeable in risk management and serves as a subject matter authority in the therapeutic area and patient risk management throughout the product lifecycle, from new product development, to launch and commercial life. The MSO plays a pivotal role in evaluating customer/user risk and in assessing the actual or potential impact of product performance issues on patient safety. The reactive elements of the role (addressing Quality/performance issues) are balanced with the need for a proactive approach in continually assessing all available information/data sources and advising on any mitigating activities which should be taken to minimize potential risk to patients. Further, the MSO must be a trusted partner in the innovation process, engaging with R&D and quality engineering to drive MD&D’s patient-centered innovation process. The primary responsibility will be for Electrophysiology, Cardiac Imaging, Structural Heart, and Reprocessing

Requirements

Doctor of Medicine (MD), Doctor of Osteopathy (DO), or equivalent degree.
Minimum of 3 years clinical or research experience
Relevant experience or specific training in Cardiovascular field.
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

Nice To Haves

Preferred specialties: Electrophysiology, Interventional Cardiology, Cardiology, Interventional Radiology.
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

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. These include (but are 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 co-ordination with MD 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, for example, regulatory bodies, clinicians and patients when safety issues are involved
Coordinate with Regional Safety Officers to ensure timely coordination of information.

Benefits

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Employees are eligible for the following time off benefits:
Vacation – up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year

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