Serves as Global Safety Lead (GSL) and the Company-wide patient safety expert for assigned pharmaceutical / biological / drug-device combined products, accountable for the safety strategy and major safety deliverables for each assigned product. Leads GPSE Safety Team (GST) and Safety Management Team (SMT) for assigned compounds and products. Represents the cross-functional program team as a product safety profile and risk mitigation expert.
The Senior Pharmacovigilance (PV) Physician I is responsible for medical review of ICSRs, writing and/or reviewing signal detection reports, aggregate reports (DSURS, PSURS, PBRERs. PADERS), and risk management reports (RMPs). The Senior PV Physician I is also expected to support the QPPV in medical aspects and safety issues as may be required by Company or Client.
The Clinical Operations Program Director connects science and operations to bring clinical studies to life through the execution of clinical research programs. The Director serves as a strategic advocate for pipeline assets and provides operational reality to our scientific experiments.