Drug / Product Safety Associate

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

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.
REQUIREMENTS
Skills Required:
Clinical knowledge of various disease states, human physiology and pharmacology.
Clinical and professional writing skills
Basic level computer skills
Communication and interpersonal skills.

Skills Desired: Knowledge and understanding of Pharmacovigilance Policies and underlying global regulations with respect to adverse event reporting. Ability to manage multiple tasks simultaneously.

Education/Experience: BS in Nursing or Pharmacy preferred. Clinical experience.