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
