Hybrid Safety & PV Data Associate

Technical Resources International, Inc.; Bethesda (MD); Hybrid; USD 54,000 - 60,000; Full time

Job summary

Technical Resources International, Inc. is seeking a S&P Associate to support drug safety data operations in Bethesda, MD. The role emphasizes data collection, validation of SAE information, and collaboration with safety and medical teams.

The position requires a Bachelor’s degree, strong attention to detail, excellent communication skills, and proficiency in MS Office; hybrid work arrangement with two days in-office and three days remote is provided.

Qualifications

• Must have excellent attention to detail and strong verbal/written communication.
• Superior organizational and customer service abilities required.
• Proficiency in MS Office; SharePoint a plus.
• Knowledge of drug and vaccine development or clinical trials a plus.

Responsibilities

• Collect, organize, and interpret data to support project safety operations.
• Validate SAE entries to ensure data accuracy and resolve discrepancies.
• Collaborate with Safety Specialists, Managers, Physicians and Medical Monitors for reporting.
• Prepare data summaries or supporting materials for meetings and presentations.
• Manage safety-related communications to sites, investigators, and regulatory authorities.
• Serve as liaison for safety communications between study sites and the safety team.
• Maintain and organize safety documentation to meet regulatory requirements.
• Oversee safety box management and ensure materials are archived and accessible.
• Track distribution/receipt of safety documents to ensure timelines and compliance.
• Perform MedDRA coding and process SAEs for safety reports.

Skills

Attention to detail

Verbal communication

Written communication

Organizational skills

Customer service

Education

Bachelor's Degree

Tools

MS Office

SharePoint

Job description

Technical Resources International, Inc. is seeking a S&P Associate to support drug safety data operations in Bethesda, MD. The role emphasizes data collection, validation of SAE information, and collaboration with safety and medical teams.

The position requires a Bachelor’s degree, strong attention to detail, excellent communication skills, and proficiency in MS Office; hybrid work arrangement with two days in-office and three days remote is provided.