Organon
Manufacturer
Jersey City, United StatesAbout
At Organon, we are dedicated to advancing women's health and improving lives through innovative medicines and products. Our team is committed to addressing the unique health needs of women globally, focusing on areas such as reproductive health, hormone therapy, and menopause management. We believe in collaboration and partnerships that empower us to drive meaningful change in healthcare. Together, we strive to create a healthier future for women everywhere.
Pharmacovigilance Operations
Individual Case Safety Report (ICSR) managementRisk Management Plan (RMP) developmentBenefit-Risk assessmentAggregate report writing (e.g., DSURs, PBRERs)
Regulatory Affairs & Compliance
PV regulatory intelligence (GVP, FDA, local guidelines)Local and global PV compliance oversight
Medical Affairs & Patient Safety
Collaboration with medical affairs and clinical ops