The Drug Safety Associate II role focuses on providing support in drug safety activities, including database setup, safety report submissions, and case management. The role involves assisting with project-specific workflows, electronic documentation, and safety information management.
Key Responsibilities:
- Triage and Documentation: Review incoming reports for completeness and document them electronically.
- Data Entry & Coding: Enter case reports into the safety database and perform coding for medical events.
- Narrative Writing: Write detailed case narratives for safety reports.
- Project Support: Maintain case report files and assist Drug Safety Specialists in various activities.
- Regulatory Submissions: Assist in setting up worldwide reporting to regulatory authorities and prepare for audits and inspections.
- Team Collaboration: Work closely with medical directors, safety physicians, and attend relevant training sessions.
Key Skills:
- Analytical and problem-solving skills.
- Strong communication (verbal and written) and organizational skills.
- Ability to work collaboratively within a team.
- Client-focused mindset.
- Familiarity with computer applications and databases.
Qualifications:
- A minimum of 2 years of experience in ICSR (Individual Case Safety Reports) case processing.
- Ability to perform database and literature searches.
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