Drug safety specialist II

Summary

Pharmacovigilance Specialist with a strong foundation in clinical trials, post-marketing, and medical devices. Proficient in Narrative writing, MedDRA and WHODD using ARGUS and ArisG, ensuring compliance with ICH-GCP and USFDA guidelines. Accomplished in regulatory documentation for FDA submissions, User Acceptance Testing (UAT), and leading team case processing quality control

Expectations

Utilizing Pharmacovigilance Expertise, Regulatory Compliance and Documentation, Quality Control and Team Leadership, Further Exposure to Industry Standards, Collaborative and Multidisciplinary Environment, Continuous Learning and Development and Flexibility and Adaptable Schedules.

Employment Preferences

Expected Base Salary

**,000 USD

Expected Hourly Rate

** USD/hr

Academic Degree

Experience

Skills

• Clinical Expertise In Therapeutic Areas
• Drug Classes.
• Exceptional Written
• Verbal Communication Skills.
• In-depth Understanding
• Global Drug Safety Regulations.
• Proficient In Microsoft Office
• Teams
• OneNote.
• Skilled In Pre
• Post-marketing Pharmacovigilance.
• Clinical Registration.
• DSUR
• PSUR Drafting
• Acing