Literature Surveillance Scientist

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Product Safety

Job Sub Function:
Pharmacovigilance

Job Category:
Scientific/Technology

All Job Posting Locations:
Raritan, New Jersey, United States of America

Job Description:

About Innovative Medicine:
 

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.

Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
 

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
 

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for a Literature Surveillance Scientist to be onsite in Raritan, NJ.
 

A pre-identified candidate for consideration has been identified.

However, all applications will be considered.
 

Purpose:
 

The Literature Surveillance Scientist (LSS) is responsible for the benefit/risk assessment of references retrieved in the global weekly literature search for assigned products and classes, and will execute clear, concise, and timely communications regarding potential new safety information to the Medical Safety Officer (MSO) as per standard procedures.
 

The LSS is expected to possess and remain current in their knowledge of the Reference Safety Information (CCDS, IB, others), Risk Management Plans, and other global safety documents for assigned products.

The LSS will utilize this context to critically review the published and pre-publication literature for the identification of potential signals, and will select references and draft MAH comments to be included in scheduled aggregate reports.
 

In addition, they will participate in the ongoing assessment of literature surveillance processes, systems, and internal controls to assure that qualitative and quantitative service goals are met.

You will be responsible for:
•    Assume primary responsibility for a portfolio of assigned products requiring scheduled weekly global literature surveillance.
•    Review search outputs for potential signals, and write a cogent, concise escalation rationale to the MSO when warranted.
•    Assess search outputs for aggregate reporting criteria, write draft company comments, and present/defend verbally and in writing to the Medical Safety Officer and product team.
•    In collaboration with Medical Safety Officer, identify medical conce...