BIOCLINICA Drug
Safety Associate I
Essential
Duties and Responsibilities:
As Quality
Check Reviewer
Review data
entered in safety database for completeness and accuracy.
Provide
quality feedback to team resources
Track and
maintain quality metrics
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.
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.
Mentor and
guide the activities of the Dug Safety Associate.
High level of
proficiency al all workflow tasks.
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 with 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.
Relevant
product and industry knowledge.
Experience
with relevant software applications.
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.
Compliance:
Awareness of
organizational policies & procedures governing his/her job
responsibilities. Awareness and compliance of QMS & ISMS policies &
procedures and their impact at his/her job level. Should understand escalation
matrix and escalate to the next level whenever incidents happen which are not
in compliance with organizational, QMS & ISMS policies and procedures.
Working
Conditions: Normal office environment.
Hours:
Standard
Hours 40 hours per week, one hour lunch, Monday – Friday. Additional hours as needed.
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