Contract Clinical Trial Drug Safety Associate - Nutley, NJ

We have a new Drug Safety Associate position open in Nutley, New Jersey. This is a full time contract position for up to 3 years with an awesome pharmaceutical company!

 

Description:The Drug Safety Associate is primarily responsible for the activities associated with the collection, coding and assessment of case report forms in drug safety.  The role may include interactions with prescribers and patients at the local level or members of the Clinical Team at the global level.  The role may also include activities on grouped data under the supervision of a DSPC or DSS.  The individual is responsible to perform these tasks in accordance with the sponsor's policies and procedures.  In addition, the DSA may perform other tasks associated with the evaluation of safety data under the supervision of other members of the Drug Safety Department

 

Responsibilities:Capture of data from serious adverse event reports from clinical trials Data capture for spontaneous cases Coding of individual case reports Assessment and coding of seriousness and labelling Preparation of an initial assessment of drug safety reports Communication and follow-up on relevant safety information with external health care professionals Communication and follow-up on relevant safety information with external health care professionals Provide instruction or training to other company personnel on Drug Safety policies and/or procedures Assists in the development of Drug Safety policies and procedures Assists in the preparation of Drug Safety reports Assists in the preparation of Drug Safety Periodic Reports

 

ABSOLUTE REQUIREMENTS FOR CONSIDERATION:Ability to acquire knowledge in different diseases and therapeutic areas, willing to upgrade skills and medical/scientific knowledge base Knowledge of MedDRA Clinical Trials Experience


Education: BSN, RN, PharmD, or equivalent medical/scientific qualification