Job Summary
A global biopharmaceutical company has a current position open for a Remote Womens Health Drug Safety Associate Principal Scientist.
Must be able to:
- Perform medical reviews of serious adverse experience reports and other AE reports of interest to monitor and describe the safety profile of assigned products
- Take a leadership role in the oversight and development of pharmacovigilance and risk management plans
- Author PSURs and other regulatory documents
Skills and Requirements Include:
- Bachelor’s degree in nursing, pharmacy or other relevant health field
- Minimum of 4 years of relevant clinical health field experience and 4 years of relevant Pharmacovigilance experience in the review of aggregate safety data and authoring of safety documents; OR
- Masters degree in nursing, pharmacy or relevant health field
- Minimum of 2 years of relevant clinical health field experience and 4 years relevant Pharmacovigilance experience in the review of aggregate safety data and authoring of safety documents
- Proficiency in retrieval, and preliminary analysis of safety data for responses to inquiries from health professionals, regulatory agencies and other customers regarding adverse experiences reported
- Advanced knowledge of safety surveillance/pharmacovigilance and epidemiologic principles