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Johnson & Johnson Services, Inc.

Drug Safety Associate 1 of 3

Johnson & Johnson Services, Inc. - Raritan, NJ

Janssen Research & Development, a part of the Johnson &Johnson family of companies, is recruiting for a Drug Safety Associate to be
located in Horsham PA or Raritan, 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:\/\/ 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. Thriving
on a diverse company culture, celebrating the uniqueness of our employees and
committed to inclusion. Proud to be an equal opportunity employer. The
Drug Safety Associate is responsible for the case processing 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. Responsibilities: Case
processing: completion of full case information on the database, including
quality review to ensure accuracy and completeness Triage of incoming cases to prioritize for daily workflow managementCompletion of remaining case data entry (including narrative or auto-narrative), manual coding, label and approvalPreparation of SUA summary: Analysis of Similar EventsPerform quality review of ICSR which includes review of source documents and ensuring that the case is accurate and that corrections to the case, if applicable, are incorporated.Liaison with Case Receipt and\/or Safety Surveillance Physicians (SSP) staff as appropriate to clarify appropriate information required for case processingOther activities relating to case processing as appropriate per case, including but not limited to:Single case unblinding, Serious Adverse Event (SAE) \/Adverse Event (AE) reconciliation, deviation memo preparation, deletion\/admin edit requests, review protocol update request forms for accuracy Processes
& procedures: awareness of and input to company procedures and guidance Completion of all assigned training on company and GMSO procedural documents relating to case processingCompletion of training relating to relevant PV Agreements for assigned productsParticipate in designated activities to support revision\/creation of case processing procedural documents Project
work: participation in assigned projects, including inspection\/audit readiness
activities Participation in local or global project teams, including on-time delivery of assigned responsibilitiesParticipation in inspections and audits as identified, including interviews and provision of requested dataPersonal development: continuous development of personal skills whether task or competency-related. Activities may include project involvement, technical training, shadowing and\/or mentoring others, soft-skill development. Perform
other related duties as required Mentoring of other DSAs or staff, as identifiedMaintains compliance with company guidelines and HR Policies
QualificationsRegistered Nurse OR Health\/Biomedical Degree (BS, PhD or other related scientific degree\/qualification) OR Associates Degree in Nursing or relate scientific area OR Licensed Practical Nurse without Bachelor\u2019s degree, but with knowledge of Drug Safety usually exhibited by minimum 5 years\u2019 experience in a pharmaceutical safety-related role is requiredPharmaceutical industry experience is preferred, with a focus on pharmaceutical safety related areas.Case processing experience is desiredKnowledge and experience with safety reporting and regulatory compliance, and experience of international safety reporting\/regulations are preferredUnderstanding of medical terminology and ability to summarize medical information is preferredAbility to follow guidelines and procedural documents (experience of working with SOPs etc.) is preferredFamiliarity with safety systems is preferredKnowledge or experience with Excel, PowerPoint, Visio is preferred

18 days 13 hours ago

Johnson & Johnson Services, Inc.


Drug Safety Associate 1 of 3 Johnson & Johnson Services, Inc. - Raritan, NJ, United States


Location: Raritan, NJ

Company Profile:
Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. Johnson & Johnson was founded more than 120 years ago. Since then, we’ve brought the world new ideas and products that have transformed human health and well-being.