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To apply for this position, please visit this Website.
http://biotech.fyicenter.com/jobs/99896160_Senior_Pharmacovigilance_Associate.html
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Date: 02-Aug-2007



Senior Pharmacovigilance Associate

Key Responsibilities

* Receipt, assessment, tracking, follow-up, and regulatory reporting
of adverse drug experiences. * Pharmacovigilance representation on
clinical development teams * Review of scientific literature received
from Medical Information for assigned products * Adverse Event
narrative review for quality, trends and signals * Safety database
reconciliation and coding review * Preparation of tables and
presentations for Safety Review Teams * Writing and preparing accurate
and timely reports to regulatory authorities such as periodics, annual
reports and PSURs * Coordinate regulatory responses for specific
safety concerns with marketed or investigational products * Review of
protocols, amendments, investigator brochures and study reports *
Provide data to support product registration and license maintenance
activities * Assist with audit preparation and vendor audits with
supervision * Participate in multi-functional teams and committees as
required * Training and mentoring staff as required

Educational & Experience Requirements

Essential:

* Science Degree * Previous experience working in Pharmacovigilance
with safety reporting in clinical trials, post marketing surveillance
and reporting to Regulatory Authorities * Experience with safety
database case entry, review and assessment * Protocol, Investigator
Brochure and Study Report reviews * PSUR experience in writing and
compilation * Global experience

Desirable:

* Pharmacovigilance training * Registry and Post Approval Commitment
Study experience * Biologic Product Experience

Key Skills and Competencies

* Must have a strong working knowledge of global regulations. *
Working knowledge of safety reviews of IB, protocols, clinical study
reports * Ability to respond appropriately to sensitive information
and complaints * Strong event assessment/review/documentation skills *
Safety Database experience * Working knowledge of MedDRA coding * High
level of knowledge of MS Word, Excel, PowerPoint and Outlook. * Must
be able to effectively present complex information to management, CROs
and the medical community. * Requires strong attention to detail in
composing and proofing materials, establishing priorities, scheduling
and meeting deadlines. * Must be able to work in a fast paced
environment with demonstrated ability to simultaneously manage
multiple competing tasks and demands. * Excellent written and oral
communication skills.



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BioTech FYI Center
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