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WHAT
IN
Director Pharmacovigilance Operations
Job
Regeneron
US
-
Tarrytown,
New York
Job Code - 1667
Position - See job description
Job First Active on: Thursday, November 05, 2009
APPLY TO THIS JOB (You will be applying directly to Regeneron for this position!)
JOB DESCRIPTION: Director, Pharmacovigilance Operations
The Director, Pharmacovigilance Operations will head the Pharmacovigilance
Operations group within the Pharmacovigilance & Risk Management department.
This individual is responsible for oversight of the collection, processing and
reporting of serious adverse events from clinical trials and for all
postmarketing adverse events in accordance with FDA/ICH regulations, and
Regeneron SOPs and Working Practices. He/she is responsible for all department
deliverables and the management of department staff, numbering approximately
6.
Essential Duties and Responsibilities include, but are not limited to
the following:
'X Ensure regulatory compliance with all US and
international regulations governing serious and non-serious adverse event
reporting
'X Oversee and manage activities of the Pharmacovigilance (PV)
Operations group.
'X Responsible for managing PV Operations staff, including
quality standards, adequacy of training, job performance and career
development
'X Responsible for management of all vendors providing contractual
services to PV Operations, including CROs responsible for collection and
processing of serious adverse events in Regeneron clinical trials
'X Acts as
liaison with corporate partners for safety reporting for jointly managed
clinical trials
'X Represent PV Operations at internal and external
meetings
'X Maintain knowledge of US and international regulations regarding
adverse event reporting
'X Oversee maintenance of the electronic ARISg safety
database to ensure compliance with regulatory requirements and with all
upgrades.
'X Oversee development and maintenance of PV Operations SOPs and
Working Practices
REQUIREMENTS - QUALIFICATIONS: Director, Pharmacovigilance Operations
'X Bachelor¡¿s degree and Masters Degree in a related field.
'X A minimum
of 7 years of experience in clinical trial and postmarketing adverse event
processing and submission.
'X Team leadership experience and a minimum of 2
years of supervisory experience required; participates in hiring, termination,
performance review and disciplinary processes.
'X Expert knowledge of
regulations worldwide regarding adverse event reporting.
'X Advanced knowledge
of the ARISg safety database; previous significant experience with electronic
document management systems and eCTD submissions
'X Excellent communications,
management and advanced negotiation are a must.
Reneneron
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