Associate Director, PV Process Excllence - UBC - Blue Bell, PA | Biospace
Get Our FREE Industry eNewsletter

Associate Director, PV Process Excllence - UBC

United BioSource Corporation (UBC)

Apply
Location:
Blue Bell, PA
Posted Date:
12/29/2016
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

POSITION SUMMARY:

Lead UBC international pharmacovigilance project teams to deliver milestones.


ESSENTIAL FUNCTIONS:


Oversee all aspects of the safety project conduct from Start-up through Close-Out

Manage pharmacovigilance projects 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

Requirements

QUALIFICATIONS:

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 including ICH (international conference on harmonization), EMA (European Medicines Agency) and FDA (Food and Drug Administration) 10% travel