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Director, Safety Data Ecosystem and Stronghold Analytics Lead
Company: Johnson & Johnson
Location: Fort Washington, PA
Employment Type: Full Time
Date Posted: 09/04/2021
Expire Date: 11/03/2021
Job Categories: Accounting/Auditing, Computers, Software, Healthcare, Practitioner and Technician, Personal Care and Service, Sales, Research & Development, Medical, Nonprofit and Volunteer Services
Job Description
Director, Safety Data Ecosystem and Stronghold Analytics Lead

Johnson & Johnson Consumer Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Director, Safety Data Ecosystem and Stronghold Analytics Lead, located in Fort Washington, PA.

 

Johnson & Johnson Family of Companies touches more than a billion people’s lives each day through our health care products and services, our corporate giving, and the volunteer efforts of our employees. The Johnson & Johnson Group of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units:  Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and Over-The-Counter (OTC) products.

 

Johnson & Johnson Consumer Inc., based in Skillman, N.J., is one of the world's largest consumer health and personal care products company. Our consumer companies produce many of the world's most trusted brands, among them JOHNSON'S® Baby, BAND-AID®, NEUTROGENA®, TYLENOL®, MOTRIN®, and LISTERINE®. Each one of our consumer businesses embraces innovative science to create products that anticipate consumer needs and create experiences that help them live healthy, vibrant lives.

 

The Director, Safety Data Ecosystem and Stronghold Analytics Lead will provide strategic leadership and oversight for the advancement of a “Best-in-Class Safety Data Ecosystem”, comprised of complementary internal and external data sources, such as adverse events data from the company, health authorities (i.e. FDA, EMA), product information (i.e. ingredient, formulation) and exposure data (i.e. sales, shipment).

 

The Director will serve as the Safety Analytics Lead for one of Safety Stronghold Teams.  This individual will provide medical, data and analytics expertise and lead the safety data review/analysis/assessment for one of the stronghold teams at Office of Consumer Medical Safety (OCMS).  Work in partnership with the Medical Safety Officer (MSO) and other functions to provide data in support of a product’s safety strategy, complete safety analyses and evaluations, lead safety data review, and contribute medical and data analytics insights to help interpret safety information to make a recommendation.  Lead the preparation of safety analysis and evaluations that are required for regulatory compliance, response to health authorities, and to aid in safety-related decisions for marketed products and products in development.

 

Principal Responsibilities:

  • Serve as the business owner for SMART-MDC and Safety Views, including expansion and optimization of services and opportunities for OCMS functions.
  • Elevate/Refine the Surveillance System for the Consumer Non-Medicinal portfolio producing an enhanced formula-based surveillance strategy and process.
  • Manage the Migration/Integration of Consumer Medical Device Safety Data.
  • Partner with other functions in Consumer to build a framework of seamless end-to-end product traceability, from R&D to marketed products in local markets.
  • Serve as the safety analytics lead for assigned consumer stronghold team.
  • Develop and implement the safety data analytics strategy for consumer medicinal, medical device, and cosmetic products worldwide.
  • Utilize medical and pharmacovigilance expertise to inform safety analytics strategy and to enhance SDA team knowledge of the context for their work.
  • Utilize this expertise to provide direction and guidance to project programmers/analysts.
  • Ensure data practices are compliant with U.S. and global regulations through oversight and continuous evaluation of surveillance data, systems, and procedures for extraction and transformation.
  • Serve as the point of contact for inspection/audit, quality investigation (CAPA) and training curriculum.

Qualifications
  • A minimum of a Medical Doctor (MD/OD) or equivalent degree is required.
  • A minimum of 10 years of experience in pharmacovigilance is required.
  • Strong knowledge of global safety operations and regulatory requirements is required.
  • Experience working with safety systems, including developing creative solutions and enhancements, is required.
  • Experience enhancing quality and compliance is preferred.
  • Experience designing/leading/successfully implementing process improvement activities is preferred.
  • Experience leading global teams through change is preferred.
  • Must have excellent verbal and written communication skills. 
  • The ability to collaborate with all levels and influence decision-making in a matrix environment is required.

 

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.


Primary Location
United States-Pennsylvania-Fort Washington-7050 Camp Hill Road
Organization
Johnson & Johnson Consumer Inc. (6101)
Job Function
R&D
Requisition ID
2105958263W
Contact Information
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