Drug Safety Coordinator

  • Company: Johnson & Johnson
  • Location: Morris Plains, New Jersey
  • Posted: January 05, 2017
  • Reference ID: 4254161215-en-us

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.

Primary Responsibilities:

Case Registry/Entry: The preparation of a case, from receipt to initial assignment in the database.

  • Retrieval of cases from incoming faxes, files and/or electronic case receipt system, as applicable
  • Creation of transmittal form and/or electronic documentation of key information, as applicable
  • Liaison with Case Processing staff, to clarify information
  • Clarification of unclear or illegible information with LSO, Call Centre, etc
  • Conducting duplicate searches to determine if case is initial or follow-up
  • Creation of case file (paper or electronic)
  • Registry of case to complete basic data entry registry fields
  • Assignment of MFR/AER number
  • Send 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.

  • Completion of remaining case data entry, including narrative or auto-narrative for non-serious cases, as required
  • Completion of transmittal form, if applicable
  • Request deletions/edits, as necessary

Processes and Procedures: Understand and follow GMSO systems and procedures.

  • Completion of all assigned training on company and GMSO procedural documents relating to case receipt/processing
  • Completion of training for relevant PV Agreements for assigned products
  • Provide 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 and inspections

  • Assist in supporting inspections and audits (e.g., interviews, as required)
  • Provide 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 support

  • Assist 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

database/systems functionality.

  • High School graduate is required; Bachelor’s Degree preferred.
  • Pharmaceutical industry experience is preferred, with a focus on pharmaceutical safety related areas.
  • Drug safety experience is desired.
  • Knowledge and experience with safety reporting and regulatory compliance, and experience of international safety reporting/regulations are preferred.
  • Proficient with MS Office is required
  • Data entry experience is preferred
  • Understanding of medical terminology and ability to summarize medical information is preferred

Primary Location
United States-New Jersey-Morris Plains
Janssen Research & Development, LLC. (6084)
Job Function
Drug & Product Safety Operations

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