Safety Associate - Clinical Trials/CRO

NSF • Germantown, MD

14d • $65,000 - $70,000 • Hybrid

About The Position

The Safety Associate (Hybrid Germantown, MD) assists in the processing of Serious Adverse Events (SAE) and Adverse Drug Reactions (ADR) and performs medical coding under supervision of the Medical Monitor(s).

Requirements

• RN preferred.
• 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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 1,001-5,000 employees