To apply for this position, please visit this Website.
http://biotech.fyicenter.com/jobs/99896160_Senior_Pharmacovigilance_Associate.html
To see other BioTech job op****tunities, please visit
http://biotech.fyicenter.com/
Date: 02-Aug-2007
Senior Pharmacovigilance Associate
Key Responsibilities
* Receipt, *****sment, tracking, follow-up, and regulatory re****ting
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 re****ts to regulatory authorities such as periodics, annual
re****ts and PSURs * Coordinate regulatory responses for specific
safety concerns with marketed or investigational products * Review of
protocols, amendments, investigator brochures and study re****ts *
Provide data to sup****t 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 re****ting in clinical trials, post marketing surveillance
and re****ting to Regulatory Authorities * Experience with safety
database case entry, review and *****sment * Protocol, Investigator
Brochure and Study Re****t 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
re****ts * Ability to respond appropriately to sensitive information
and complaints * Strong event *****sment/review/do***entation 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, establi****ng 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.
Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/
|
