The Global Surgery Group, a member of Johnson & Johnson’s Family of Companies is recruiting for a Medical Safety Officer, located in Somerville, NJ.
The Global Surgery Group is comprised of the following businesses within Johnson & Johnson: Ethicon Surgical Care, Ethicon Energy, Ethicon Biosurgery, Acclarent, Biosense Webster, Cordis, Mentor and Sterilmed. With annual sales of $11 billion, the Global Surgery Group is the world’s largest, most innovative surgical company. The strength of the Global Surgery Group is illustrated by the fact that more than 80% of our sales come from businesses with #1 or #2 global market share positions. We serve customers around the world, with about 60% of our sales generated outside the U.S., including a fast-growing presence in emerging markets. The Global Surgery Group is committed to innovation, with about 30% of our sales coming from products introduced in the past five years.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Medical Safety Officer is responsible for ensuring processes and resources are in place to monitor and enhance the safety of MD&D products. The MSO develops and directs the Product Safety strategy and standards for the business. Oversees the integrity, capability and reliability of all processes and systems to detect and monitor product safety in his/her assigned area and performance signals through close collaboration with Quality, R&D and Medical Affairs. Responsible for providing guidance and leadership to the product safety teams on all aspects of safety surveillance and operations, by ensuring the accurate and timely collection, recording, and evaluation of events involving post-marketing products. The MSO is an active member of a cross functional team, and a close partner with the quality leader and statistical colleagues, in assessing any potential safety signal for an MD&D product. Although a medically independent voice is key, collaboration in assessing potential safety signals is expected. The MSO plays a pivotal role in evaluating customer/user risk and in assessing the real 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.
Responsible for the overall management and effectiveness of the risk management processes with regard to patient safety. Represents the Medical Safety organization at meetings with internal and external groups to provide information on product safety, surveillance plan, results, resolutions and input into strategy and future direction. Participate on MD&D and J&J teams to align and improve processes and systems. Develops performance metrics focused on quality, efficiency and patient well being. Presents case reviews and metrics to management. Leads initiatives and strategy to meet franchise and corporate key metrics and commitments related to global implementation of enterprise standards related to product safety. Ensures personal and company compliance with all local government and company regulations, policies and procedures. Ensures conformance to company safety, quality policy.
Accountable for the medical safety aspects of Product Risk Management and Post-Market Safety Surveillance processes. Provides direction from a Medical perspective to the product safety teams responsible for risk assessment, post-market safety surveillance and MDD safety surveillance initiatives. Ensure processes are in place to guaranty appropriate medical review and input to: Risk Management Reports, Clinical Evaluation Reports, Response to AEs, complaints and mass communications, Internal and customer safety training materials, Complaint Handling processes and reportability decisions and Regulatory reports and filings. Ensure procedures are in place for continual medical review of a product’s harms and hazards list and derivations of criteria for reportability. Develops process and strategies to facilitate Medical support and expert input of the New Product Development and New Business Development teams including conceptual and hands-on product evaluation, and clinical research perspectives and expert medical support to Regulatory Affairs, Communications, Legal, and QA/Risk Management / Product Safety teams. Responsible for the review and approval of Product Safety Surveillance plans (SSPs), including risk categorization of product/product families. Ensure that PMS plans are reviewed on a regular defined schedule and updated when new data indicates that a substantial change in risk/benefit ratio has occurred.
Maintain and continuously improve global business processes to ensure appropriate trending for signal detection and timely execution of signal investigation and escalation. Oversees and ensures proper execution and compliance in safety signal investigations. Interface with customers/users to gather additional medical information / data when required to support investigations regarding safety. Communicates product safety and performance issues to management and appropriate individuals. Medical representative within the escalation process when making decisions on field actions; and evaluates the effectiveness of field safety corrective actions; may be assigned to lead cross functional discussions regarding patient safety issues. Ensure consistency in medical evaluations, Quality Review Board decisions and overall Safety evaluations of products. Responsible for the review and approval of the Health Hazards Evaluations.
Recommends appropriate actions. Drives collaboration with clinical, regulatory and R&D teams, and corporate partners in the development of safety reporting procedures and post marketing activities. Work closely with Medical Affairs and Clinical organization to ensure consistency in medical evaluations, and overall Safety evaluations of product. Ensures mechanisms are in place to provide feedback to the R&D organization on potential areas for improvement for MD&D product based on Post-Market Surveillance data. Provide strategic direction in order to develop integration plans for new products and patient registries. Establishes and maintains global relationships with partnering organizations and regulatory bodies. Interacts with manufacturing sites and marketing sites worldwide. Maintains global awareness at the sector and enterprise level to define best practices and implement at the franchise level.
Represents the Medical Safety organization at meetings with internal and external groups to provide information on product safety, surveillance plan, results, resolutions and input into strategy and future direction. Participate on MD&D and J&J teams to align and improve processes and systems. Identify key organizational needs and design/implement solutions which are relevant and aligned to the MD&D Quality standard. Develops performance metrics focused on quality, efficiency and patient well being. Presents case reviews and metrics to management. Leads initiatives and strategy to meet franchise and corporate key metrics and commitments related to global implementation of enterprise standards related to product safety. Ensures personal and company compliance with all local government and company regulations, policies and procedures. Ensures conformance to company safety, quality policy.
- An MD/DO is required for this role
- At least 3 years, post residency, General Surgical practice experience is required.
- Demonstrated leadership skills, mentoring skills and the ability to make quick decisions are required
- Excellent communication skills, including written and oral presentation of scientific data and research results are required
- Excellent people management, leadership, organizational, interpersonal, and reasoning skills are required
- Medical device, biologics and/or pharmaceutical industry experience is preferred
- Experience in risk evaluation and mitigation is preferred
- Clinical study/research experience is preferred
- Knowledge of basic statistical techniques is preferred
- Knowledge of basic epidemiological principles is preferred
- Experience of interfacing with senior leadership within a global healthcare company is preferred
- Experience interacting with Regulatory Agencies is preferred
- Understanding of CFR Title 21, ISO 13485, ISO 14971, European Medical Device Directives & worldwide pharmacovigilance regulations are preferred.
- Travel of 10% is required
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How to Apply
Please visit: http://bit.ly/1vKtcua to submit your online application