Regulatory/Drug Safety Associate

MedFocus offers clinical and scientific research contract outsourcing and staffing specifically to the pharmaceutical, biotechnology and medical device industries.  We specialize in the nationwide recruitment of clinical trials personnel and scientific / laboratory personnel.  MedFocus has grown substantially year after year since 1993 to achieve premier status as a top source of hiring for clinical research managers coast to coast.

 

Contract Regulatory Associate / Global Product Safety Associate needed in Indianapolis, IN, for major pharmaceutical client!

 

This is an 18 month contract that is 40 hours/week, first shift, Monday-Friday.

 

Pay rate is based on experience.

 

Duties to Perform: Primarily responsible for assessment and entry of adverse event cases. Case management will include: entry of data, coding of medical terms, follow-up, and quality review of individual cases. Must be able to interpret and apply medical concepts to individual case reports. Need to be able to quickly learn basic system navigation and data entry skills. Good communications skills are essential in order to conduct follow up communications on individual adverse event cases with health care professionals, consumers and sales representatives to produce high quality complete reports. May be asked to perform tasks associated with medical device process.

 

Skills Required: Candidate MUST have a solid nursing background.  The DESIRED educational level is a BSN, however the REQUIRED minimum educational level is a candidate with a BS/BA degree AND an ASN.  If a candidate does not meet either of these education requirements, they can not be considered for this position. 

 

The candidate should possess clinical knowledge of various disease states, human physiology and pharmacology. Clinical and professional writing skills. Basic level computer skills. Good communication and -interpersonal skills are required. Skills Desired: Knowledge and understanding of Pharmacovigilance Policies and underlying global regulations with respect to adverse event reporting. Ability to manage multiple tasks simultaneously.