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.
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.
of cases from incoming faxes, files and/or electronic case receipt system, as
of transmittal form and/or electronic documentation of key information, as
with Case Processing staff, to clarify information
of unclear or illegible information with LSO, Call Centre, etc
duplicate searches to determine if case is initial or follow-up
of case file (paper or electronic)
of case to complete basic data entry registry fields
of MFR/AER number
case numbers to LSOs/Call Centre, etc., as applicable
Case Processing: The completion of
case information in the database, culminating in Quality Review to ensure
accuracy and completeness.
of remaining case data entry, including narrative or auto-narrative for
non-serious cases, as required
of transmittal form, if applicable
deletions/edits, as necessary
Processes and Procedures:
Understand and follow GMSO systems and procedures.
of all assigned training on company and GMSO procedural documents relating to
of training for relevant PV Agreements for assigned products
assistance in supporting revision/creation of case receipt procedural documents
Project Work, Audits, Inspections
and other Ad-hoc Requirements: Participate in GMSO projects, preparation for audits
in supporting inspections and audits (e.g., interviews, as required)
support for local or global project teams
Mentoring: Enhancement of the
formal training program, through the provision of
on-going, on-the-job guidance and
with provision of on-the-job training and support to other Safety Coordinators
Application and knowledge within
single case receipt context of: GMSO processes and guidelines,
regulations and regulatory
guidelines, contractual agreements, product-specific information and
School graduate is required; Bachelor’s Degree preferred.
industry experience is preferred, with a focus on pharmaceutical safety related
safety experience is desired.
and experience with safety reporting and regulatory compliance, and experience
of international safety reporting/regulations are preferred.
with MS Office is required
entry experience is preferred
of medical terminology and ability to summarize medical information is
United States-New Jersey-Morris PlainsOrganization
Janssen Research & Development, LLC. (6084)Job Function
Drug & Product Safety Operations
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.