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