Job Summary

A clinical and scientific staffing company is filling a position for a Remote Medical Safety Specialist.

Core Responsibilities of this position include:

• Perform medical interpretation and analyses of safety data, including both ICSRs and aggregate data
• Support of writing and review regulatory documents, including periodic reports, signal evaluation reports and other analyses
• Serve as the safety point of contact to other colleagues (RA, QA, Medical Affairs)

Skills and Requirements Include:

• Physician with relevant, hands on safety experience
• At least 3 years of hands on PV experience in clinical and/or post marketing
• Solid understanding of global regulations impacting Pharma industry, especially drug safety/ PV
• Hands on experience writing/reviewing Aggregate Reports, e.g., PBRERs, DSURs, and PADERs
• Hands on experience with signal detection activities such as analyzing/categorizing/ assessing data
• Strong leadership skills