Project Manager, Pharmacovigilance
United BioSource Corporation - Blue Bell, PA

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Brief Description:
Lead UBC pharmacovigilance project teams to deliver project milestones

Specific Job Duties:
• Oversee all aspects of the safety project conduct from Start-up through Close-Out
• Manage project per the scope of work and within the contracted budget
• Review contracts and ensure that change orders are issued, as necessary
• Ensure project is conducted in concert with UBC SOPs, project-specific procedures and client’s SOPs as appropriate
• Develop plans to achieve contracted milestones (i.e., Adverse Event Reporting Plan, Safety Data Management Plan)
• Ensure project specific staff training and associated documentation
• Prepare project timelines and project management related deliverables
• Identify percent complete units for monthly revenue recognition meeting with Finance as well as forecast future unit completion
• Ensure project budget is tracked against contract milestones
• Serve as UBC primary contact with the client
• Lead internal project and client conferences
• Focal point for resolving project team member questions
• Present project information at bid defenses, client meetings and UBC project review meetings
• Prepare project specific presentations
• Assist in project specific audit preparation and actively participate to the audit
• Coordinate meetings
• Ensure full documentation of project files
• Support QPPV in his/her activities throughout the project
• May be asked to support Safety Scientist and Safety Data Associate/Manager in their duties as needed and appropriate
• Prepare project KPI and monthly report
• Other duties as assigned by management
Supervisory Responsibilities:
Matrix supervision of project team
Expected Project Load:
3 to 5 projects (local and global) depending on scope
*LI-CW2
Qualifications:
Requirements:
• Bachelor, MSc or equivalent
• 2 year direct project management experience at a CRO or pharmaceutical company and/ or 2 or more years of pharmacovigilance experience
• Demonstrated supervisory skills
• Excellent interpersonal skills
• Excellent presentation skills
• Demonstrated knowledge of pharmacovigilance regulatory requirements (i.e. Good Clinical Practice, ICH guidelines, etc.)
• 10% travel
We are an Equal Opportunity Employer, M/F/D/V
GES

United BioSource Corporation - 19 months ago - save job - copy to clipboard
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