Drug Safety Specialist II

This is a fully remote position, open to applicants in United States.

📋 Description

• The role involves, but is not limited to, the development of safety management plans, managing serious adverse events (SAEs and SUSARs) from initial intake to regulatory reporting, and offering safety expertise promptly upon request from team members, clients, and study site personnel.

• Collaborating with sponsors, vendors, and internal team members in the safety domain to aid in the design and implementation of tools, processes, and systems for safety data collection and reporting.

• Engaging in the evaluation and establishment of a safety database to capture SAE data.

• Conducting intake, triage, data entry, medical coding, assessing expectedness, and composing narratives and analyses of similar events for individual case safety reports (ICSRs), while adhering to relevant regulations and company policies.

• Performing quality control on documents and safety reports.

• Preparing and/or reviewing project-specific safety reporting plans and medical coding strategies.

• Preparing and/or reviewing safety training materials.

• Providing safety training and oversight for consultants, contractors, and/or staff.

• Reviewing and/or drafting standard operating procedures and work instructions.

• Assisting clients and/or other departmental personnel with safety-related evaluations and additional services.

• Undertaking other duties as assigned.

⛳️ Requirements

• A Bachelor’s degree (BA/BS)

• At least 2 years of experience in safety

• A professional background in healthcare

• Practical experience with global safety databases, SAE case processing including narrative composition, and the generation of safety reports

• Familiarity with MedDRA and WHODrug

• Knowledge of FDA safety regulations, ICH guidelines, and global safety regulations.

🏝️ Benefits

• Health insurance

• Retirement savings benefits

• Life insurance

• Disability benefits

• Parental leave

• Paid time off for sick leave and vacation