DRUG SAFETY ASSOCIATE

MISSION STATEMENT:

A new opportunity exists in an expanding Drug Safety and Pharmacovigilance department.  We are currently recruiting a qualified health professional (RN preferred) to manage AE / SAE and other safety-related issues in accordance with global safety regulations.
 

RESPONSIBILITIES:

• Will manage AE/SAE in oncology clinical trials including the collection, evaluation, collation and reporting of cases in accordance with global safety regulations, departmental SOP’s and company policies.
• Will perform verification of safety data, maintain case files and source documents, and prepare AE/SAE narratives.
• Will have daily direct interactions with clinical trial sites and 3rd party vendors in processing cases and will act as the liaison for safety on multi-disciplinary teams, assisting in the development of study-related documents including protocols, CRFs and Investigator Brochures.
• Will assist in implementation of safety databases.
 

QUALIFICATIONS:

• RN, RPh. or PharmD preferred with 3+ years in product safety
• Must have knowledge of safety regulations (ICH, FDA) and have experience with MedDRA.
• Experience with drug safety databases.
• Attention to detail and excellent written, verbal and interpersonal skills