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Aggregate Reporting Manager

Company: GForce Life Sciences
Location: Princeton
Posted on: May 14, 2022

Job Description:

Consultant, PV, Aggregate Report/ Operations Manager, Pharmaceuticals

Responsibilities
Support roles involved in the creation of Aggregate Safety Reports (ASR)
Facilitate Aggregate Report production activities across CSPV and other organizations for PSUR, RMP updates, DSURs, and other reports as required
Participate in project teams and facilitate coordination of activities required to implement initiatives
Request standard output for ASRs according to project plan timelines
Lead ongoing ASR production meetings

Perform the following project management activities on CSPV projects:
Collaborate with the project team to establish and maintain project charter and scope documents.
Establish and drive execution of actionable project plans for the projects.
Facilitate cross-functional project meetings to enable alignment, and advancement of key project deliverables.
Work with the cross-functional project teams to define, capture and track actions, decisions, issues, and risks to the project.
Develop and report out to leadership project dashboards to enable concise and effective updates on project status and escalation of current issues and risks

Perform the following project management activities to enable effective facilitation of the Global PV Safety Governance teams:
Collaborate with the project team to establish and maintain project charter and scope documents.
Facilitate safety governance meetings and document/publish discussion, actions and decisions.
Capture and track actions, decisions, issues, and risks identified during the safety governance meetings
Education and Experience
5+ years of global aggregate report experience
Extensive knowledge of US, ICH, and EU PV and GCP regulations
Experience in table generation for aggregate reports
Experience with CA Inspections (PV and GCP)
Experience managing vendors
Experience working with Alliance Partners and managing Pharmacovigilance Agreements
Advanced Health Care Professional degree required (MD, PharmD., Nurse Practitioner, Physician Assistant)

Term
12+ month contract with the ability to extend
Remote - prefer local to NJ for potential onsite meetings
EST work hours
Full time (40hrs/week)
Benefits included - health, dental, vision, 401k

Keywords: GForce Life Sciences, Trenton , Aggregate Reporting Manager, Advertising , Princeton, New Jersey

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