Safety Associate - Clinical Trials/CRO

NSF is a company with a legacy spanning more than 80 years, focused on improving human and planet health through science-driven services. The Safety Associate will assist in the processing of Serious Adverse Events and Adverse Drug Reactions, performing medical coding and providing support for the Safety Department.

Responsibilities

• Enter incoming safety events into related tracking systems and databases
• Handle incoming safety-related reports from clinical trial sites
• Process expedited/non-expedited safety events based on the Medical Monitor’s evaluation in accordance with company’s SOPs and other regulatory guidelines
• Perform data reconciliation for ad hoc and annual safety reports
• Write SAE narratives
• Organize, attend and take minutes of Safety Department meetings
• Provide administrative/logistical support for the Safety Department
• Perform medical coding based on MedDRA and WHO Drug dictionaries under supervision of the Study’s assigned Medical Monitor(s)
• Other duties as assigned

Skills

• Bachelor's degree in scientific or medical curriculum, or equivalent professional experience
• At least one year of clinical research and drug safety and pharmacovigilance experience
• Competent in the use of Microsoft Office software
• Understanding of medical terminology
• Ability to work effectively both independently and in a team environment
• Strong problem solving and decision-making skills
• Strong oral communication skills
• Written communication abilities to include drafting of memos, formatting and taking minutes
• RN preferred

Company Overview

Company H1B Sponsorship