Janssen Research & Development, a part of the Johnson & Johnson family of companies, is recruiting for a Drug Safety Coordinator in the Global Medical Safety Organization to be located in Morris Plains, NJ.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.
Please visit http://www.JanssenRnD.com for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The Drug Safety Coordinator will be responsible for the receipt and data entry of adverse event reports following Company Standard Operating Procedures, internal business practices and regulatory guidance documents to ensure compliance with worldwide safety regulations and corporate policies.
Case Registry/Entry: The preparation of a case, from receipt to initial assignment in the database.
Case Processing: The completion of case information in the database, culminating in Quality Review to ensure accuracy and completeness.
Processes and Procedures: Understand and follow GMSO systems and procedures.
Project Work, Audits, Inspections and other Ad-hoc Requirements: Participate in GMSO projects, preparation for audits and inspections
Mentoring: Enhancement of the formal training program, through the provision of
on-going, on-the-job guidance and support
Application and knowledge within single case receipt context of: GMSO processes and guidelines,
regulations and regulatory guidelines, contractual agreements, product-specific information and