Associate Medical Safety Officer - Santa Clara, CA

Johnson and Johnson is currently seeking an Associate Medical Safety Officer to join our team in Santa Clara, California.

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.

Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at https://www.jnj.com/.

The Associate Medical Safety Officer (aMSO) role is to provide medical safety stewardship for Medical Device & Technology (MedTech) 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 a MedTech 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 aMSO will build clear and positive relationships between R&D, Quality, Regulatory, Clinical, Epidemiology and Safety sciences and Safety process groups to allow for proactive and flexible risk management.

The aMSO 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 aMSO 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 aMSO must be a trusted partner in the innovation process, engaging with R&D and quality engineering to drive a patient-centered approach to design and development.

Section III: Principal Duties & 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 ...