As a Sr. Clinical Project Manager, you will reimagine how therapies are brought to life and bring hope to patients around the world. Your expertise in clinical development and strategic program leadership will be critical in accelerating the mission to launch life-changing medicines. You will lead the orchestration of program plans, ensuring timelines, dependencies, and deliverables are aligned.
Primarily responsible for ensuring the timely release of GMP clinical supplies by providing direction and quality oversight of the supply chain including, manufacturing, testing and release processes from drug substance to drug product to finished product. As a team member, the Senior Manager is responsible for early identification and prevention of pipeline risks by driving consensus-building across AbbVie R&D functions and external partners.
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.