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UBC - Associate Director, Pharmacovigilance (PV) 8/30/2016

Express Scripts Blue Bell, PA

Company
Express Scripts
Job Classification
Full Time
Company Ref #
1600003K
AJE Ref #
576014311
Location
Blue Bell, PA
Experience
Mid-Career (2 - 15 years)
Job Type
Regular
Education
Bachelors Degree

JOB DESCRIPTION

APPLY
Schedule: Full-time

Job ID: 1600003K

BRIEF DESCRIPTION:



Responsible for establishment
of standardized quality metrics for the UBC Global PV Department and for PV
projects contracted by UBC clients. Responsible for the development and
maintenance of the UBC PV procedural documents and for serving as the lead global
PV trainer. Responsible for the prioritization and dissemination of information
relating to global PV Safety Regulatory Intelligence.





REQUIREMENTS:

* Bachelor's Degree
in a science or health-related field, pharmacy or nursing required.
* Minimum of 8
years of experience in a pharmaceutical company or a service provider (e.g.,
CRO).
* Minimum 4 years
of experience at increasing levels of responsibility in PV Operations including
team management responsibilities.
* Advanced
knowledge of global and local PV regulations and legislation, both pre- and
post-marketing required.
* Strong
leadership, analytical, and organizational skills required.
* Strong written
and verbal communication skills.
* Strong
presentation skills.
* Strong
interpersonal skills.
* Must be able to
speak fluent English.
* Proficient with
computer programs (WORD, PowerPoint, excel)
* Experience in the
development of a PV Quality Management System and in utilization of Six Sigma
methodologies and tools preferred.
* Ability to travel
from time to time to UBC locations, clients, and professional/scientific
meetings.

ESSENTIAL FUNCTIONS:


* Responsible for
monitoring global regulatory reporting compliance by providing metrics for
7/15/90- day individual case safety reports (ICSRs) and for periodic safety
reports per UBC client and product to appropriate UBC leaders.
* Ensures the timely completion of root
cause analyses of any non-compliance with UBC and/or project specific processes
and corresponding corrective and preventative actions (CAPAs).
* Generates
productivity metrics from Argus per UBC PV user utilizing PV specific tools and
processes.
* Generates
quality metrics for all PV processes at UBC and project level, e.g. Ensures
data entry guidelines are consistently applied across UBC PV projects via the
development of a quality control sampling process.
* Ensures
timely completion of audit and inspection CAPAs relating to PV processes and
procedures in collaboration with PV Directors.
* Reviews
root causes and CAPAs periodically with UBC PV Leadership to identify trends.
* Provides
support for the generation and maintenance of standard operating procedures
(SOPs), working Practices (WPs), Business Continuity Plans, for the global PV
organization to ensure global regulatory reporting compliance for adverse
experience reports.
* Oversees
the collection, dissemination, and prioritization of global PV information
identified by the Safety Regulatory Intelligence group. Ensures that global
SOPs are up-to-date and that staff are appropriately trained.
* Provides
notification to Project Managers of changing regulations to ensure that client
plans concerning adverse experience reporting are up-to-date.
* Works
with UBC Quality Trainer to ensure new employees in PV complete the PV specific
training plan. Ensures that refresher training for UBC concerning the reporting
of adverse experiences is completed according to schedule.
* Provides
PV specific training on regulatory driven changes to UBC processes and
procedures.
*
Conducts
regular meetings with his/her direct PV reports.
* Participates
in project specific internal teleconferences/meetings and client specific
teleconferences/meetings for operations as needed.
* Attends
client operational Face to Face meetings and teleconferences as needed
* Evaluates
and responds to client requests for proposals as needed. Participates in
bid-defense preparation and attendance as needed.
* Attends
and supports client audits and regulatory inspections from a pharmacovigilance
operations standpoint.
* Ensures
completion of employee performance objectives and development plans for direct
reports. Conduct annual employee performance evaluations.
*

Performs additional duties as assigned by UBC
Management.

ABOUT EXPRESS SCRIPTS

Advance your career with the company that makes it easier for people to choose better health.
Express Scripts is a leading healthcare company serving tens of millions of consumers. We are looking for individuals who are passionate, creative and committed to creating systems and service solutions that promote better health outcomes.
Join the company that Fortune magazine ranked as one of the 'Most Admired Companies' in the pharmacy category. Then, use your intelligence, creativity, integrity and hard work to help us enhance our products and services.
We offer a highly competitive base salary and a comprehensive benefits program, including medical, prescription drug, dental, vision, 401(k) with company match, life insurance, paid time off, tuition assistance and an employee stock purchase plan.
Express Scripts is committed to hiring and retaining a diverse workforce. We are an Equal Opportunity Employer, making decisions without regard to race, color, religion, sex, national origin, age, veteran status, disability, or any other protected class. Applicants must be able to pass a drug test and background investigation.
Express Scripts is a VEVRAA Federal Contractor.
ABOUT UBC

United BioSource Corporation (UBC) is the leading provider of integrated development and commercial support solutions that deliver evidence of safe use, while optimizing access to mediation and care.

UBC leverages our specialty pharmacy therapy expertise and contracts for specialty pharmacy and specialty distribution services.

UBC's services include reimbursement, patient assistance and alternate funding programs, channel optimization through specialty pharmacy, specialty distribution and 3PL services, Customized clinical adherence and commercialization strategies powered by Express Scripts data.

Express Scripts is an EOE
Express Scripts is an Equal Employment Opportunity employer and does not discriminate in employment opportunities or practices on the basis of race, creed, color, religion, sex, national origin, nationality, ancestry, age, disability or status as a disabled veteran or veteran of the Vietnam era, pregnancy, affectional or sexual orientation, gender identity or expression, marital status, status with regard to public assistance, veteran status, citizenship or membership in any other legally protected class. None of the questions in this application are intended to elicit information regarding any protected characteristics, nor imply any limitation, illegal preferences or discrimination based upon non-job-related information or protected characteristics.Applicants must be able to pass a drug test and background investigation and, depending on position requirements, a Department of Defense background investigation. AA/EOE.