BIOCLINICA Jr. Drug Safety Associate Apply Now Share with Job seekers
Essential
Duties and Responsibilities:
As Case
Intake Member:
Responsible
for case intake, duplicate check, and registration
Maintain log
of source documents and other communications
As Case
Processor:
Responsible
for data entry of individual case safety reports into the safety database.
Review and
evaluate AE case information to determine required action based on and
following internal policies and procedures
Process all
incoming cases in order to meet timelines
Full data
entry including medical coding and safety narrative
As Medical
Coder
Responsible
for coding all medical history, events, drugs /procedures/indications and
laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company
Product Dictionary, WHO-DD)
As Narrative
Writer
Responsible
for writing medically relevant safety narrative of cases and checking the
completeness and accuracy of the data entered in the various fields.
As
Literature Review Specialist
Ensure
effective and accurate collection, recording, review and reporting of
literature searches conducted.
Review of
literature articles to identify case safety reports.
Responsible
for operational Pharmacovigilance activities for assigned developmental and/or
marketed products.
Assist in
signal generation and safety analysis activities.
Ensure
quality of literature searches and reporting.
Review of
local/global literature reports to determine regional reportability.
Create/maintain
study summary documents.
Assist with
narrative writing for periodic/ad hoc submissions.
Assist with
ad hoc or routine safety monitoring activities.
Other
Responsibilities:
Following up
with sites regarding outstanding queries.
Follow up on
reconciliation of discrepancies.
Follow
departmental AE workflow procedures
Closure and
deletion of cases
Perform any
other drug safety related activities as assigned
Specialized
knowledge and skills:
Basic
competence with medical and therapeutic terminology.
Ability to
work independently but guided by documented procedures, with appropriate
support.
Able to work
effectively as part of a team.
Understanding
of patient safety regulatory obligations.
Should be
familiar regulatory &pharmacovigilance guidelines.
Should be
familiar with pharmacovigilance terminology.
Excellent
attention to detail.
Ability to
deliver within established timelines.
Fluency in
English and excellent comprehension.
Computer
literate.
Communication
Skills:
Requires a
proactive approach and excellent written/oral communication and interpersonal
skills. Strong interpersonal skills required to interact with clients,
management, and peers effectively. Effective cross- department communication.
Ability to document and
communicate problem/resolution and information/action
plans.
Desired
technical skills:
Person
should be familiar with MS Office Tools.
Safety
database knowledge.
Other
skills:
The ability
to contribute to a team environment with a high degree of professionalism and
skill. Demonstrate flexibility within a dynamic, fast-paced, cross-functional
team.
Demonstrated ability to complete multiple tasks concurrently and deliver
results in a fast-paced environment. Ability to perform under stringent
timelines.
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