HireDiversity

Fort Washington, PA, US

Device Vigilance Physician (Consumer), Office of Medical Safety-6306130103

Description

Johnson & Johnson Consumer Products Company, a member of the Johnson & Johnson family of companies, is recruiting for a Device Vigilance Physician (Consumer) for its location in Fort Washington, PA.

Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. develops and markets baby care, wound care and skin care products that address the needs of consumers and health care professionals and incorporate the latest innovations. The portfolio includes heritage brands JOHNSON'S® Baby and BAND-AID® Brand, as well as leading skin care brands such as AVEENO® and CLEAN & CLEAR® and NEUTROGENA.

The Associate Director, Device Vigilance Physician is the medical expert who assists with medical oversight for medical device malfunctions and related adverse events associated with consumer and personal care products.

The Device Vigilance Physician (DVP) will assist overseeing all medical aspects relating to individual case safety reviews (ICSR) and the case management processes for adverse event and medical device malfunctions and related adverse event reports; and support the regulatory reporting requirements in accordance with US and international regulations, standard operating procedures, and applicable contractual terms. The DVP is a subject matter expert who provides strategic insight and guidance to the organization on medical aspects of: (a) individual case safety report review for medical device malfunctions and case management strategies to meet current and emerging global regulatory requirements; (b) the development of consistent, standardized processes through controlled documents, process compliance management, and implementation of corrective and preventative actions to remediate non-conformance issues; and, the implementation of global device malfunction; and (c) vigilance systems and related information technology solutions.

On a day-to-day basis, the DVP will assist the Director-Senior Product Vigilance Physician and Associate Director, Device Malfunction Operations in overseeing the medical aspects of staff training and compliance, managing medical aspects of global operations taking place in four continents, monitoring performance indicators to achieve operational excellence, and performing ICSR and device malfunction assessments.

The DVP must be able to work independently making decisions about the appropriate course of action to resolve medical and malfunction review issues; escalate safety observations and alerts; and develop close working relationships in a highly matrixed, global organization. Significant interfaces include but are not limited to MDC peers, OCMS colleagues, Regulatory Affairs and Quality Assurance. Interactions with safety, medical and regulatory staff of Operating Companies are expected to occur regularly. Additionally, the DVP will complete safety review projects as assigned by Director- Senior Product Vigilance Physician.

This position requires up to 10% global and domestic travel in support of business needs.

Qualifications


An MD or equivalent is required for this position. A minimum of four (4) years of experience in marketed product safety and/or clinical experience is also required.

Expert level knowledge and hands-on experience in safety case management for regulatory reporting and an in-depth understanding of related medical device vigilance systems is highly preferred, as is an advanced level understanding of US and international medical device vigilance and safety regulations.

Consumer products and medical device experience is preferred, but not required. People management experience is also preferred.

Demonstrated success in working in a global, matrixed and team oriented environment is essential for success, as is the demonstrated ability to plan, implement and execute strategic initiatives. Excellent written and verbal communication skills and strong decision making and problem solving skills and a strong attention to quality, detail and accuracy are also required skills.

This position requires up to 10% global and domestic travel in support of business needs.

BE VITAL in your career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-Pennsylvania-Fort Washington
Organization: Johnson & Johnson Consumer Inc. (6071)