Purpose:

This position reports into the Office of the Product Safety Team (PST) within the Pharmacovigilance and Patient Safety (PPS) organization’s Global PV Strategy Management Office. The PPS organization works collaboratively and strategically with colleagues across the product lifecycle to identify, evaluate, understand and communicate the safety profile of our drugs to protect patients worldwide. 

The PST is a high-profile high-impact team that leads and owns safety decisions and strategy across the product lifecycle. The team partners with stakeholders across the product lifecycle to provide innovative safety-driven strategies, which will maximize product benefit-risk for patients. The Office of the PST plays a critical role in shaping and driving the priorities of the PST by providing strategic and operational leadership oversight of the PST model. 

As an Epidemiology Study Operations Manager within the Office of the PST, you will support and partner with the Global Epidemiology organization to achieve its mission in managing the lifecycle of studies utilizing real world evidence and to ensure compliance with quality standards (Global Regulations and AbbVie policies and procedures).  

Responsibilities:  

• Strategic management and oversight of Epidemiology-led non interventional studies with progressive autonomy  

• Provide support to the Study Leader for vendor selection, scope development, management, and oversight of external vendors/CROs 

• Manage and coordinate the development of study-related deliverables including development of project plans/timelines, confirming accountabilities, document quality, driving completion of actions and escalating obstacles/risks 

• Drive study-related deliverables to ensure regulatory and process timelines are met 

• Responsible for relevant updates to the cross-functional team and stakeholders on study status 

• Leverage applicable systems and processes to enable successful tracking and completion of the study and study-related deliverables  

• Coordinate the development, review and approval of study protocol and other study-related documents  

• Maintain study-related documents (e.g., meeting minutes, IRB/EC approvals) in the appropriate document repository 

• Responsible for oversight of funds spent against approved budget 

• Proactively identify, address and escalate, as appropriate, project-related issues 

• Identify opportunity areas for efficiency and participate in department related projects in order to achieve operational excellence within Global Epidemiology and the Office of PST  

• Build solid foundation in understanding regulations and applies knowledge or regulations to guide the development study-related deliverables 

• Collaborate effectively to build and leverage relationships across functions and organizations to achieve business results 

• Participate in audit and inspection preparation and execution activities 

• Level of position is commensurate with education and experienceMinimum Education and Experience Required:For Project Manager:Bachelor of Science Degree in Engineering, Science, Business, or a financial related discipline.
• 6 + years of experience in the pharmaceutical industry with an emphasis on the technical (chemistry, biology, clinical) and business (project management, contracting, outsourcing, finance) aspects.
• PMP Certification preferred but not required.
• For Associate Project Manager:Bachelor of Science Degree in Engineering, Science, Business, or a financial related discipline.
• 4 + years of experience in the pharmaceutical industry with an emphasis on the technical (chemistry, biology, clinical) and business (project management, contracting, outsourcing.