BIOCLINICA
(www.bioclinica.com) is a global specialty clinical trials services provider
delivering expertise and technologies to enhance clinical research, data and
analytics . Bioclinica is divided into three business segments to deliver
focused service supporting multifaceted technologies. The Medical Imaging and
Biomarkers segment provides medical imaging and cardiac safety services and
includes a molecular marker laboratory. The eHealth Solutions segment comprises
an eClinical technology platform and professional services along with safety
and regulatory solutions. Under the Global Clinical Research segment,
Bioclinica offers a network of research sites, patient recruitment-retention
services, and a post-approval research division.
JOB
TITLE: Drug Safety Associate
WORK
LOCATION: Mysore, India
YEARS
OF EXPERIENCE: 0 to 2 years
EDUCATION:
Health care professional (B Pharm / M Pharm / Pharm D / BSc (Nursing) / MSc
(Nursing) /BDS / MDS / BHMS / BAMS / BPT)
Time
and Venue
29th January - 2nd February , 9 AM onwards
#120P
- 122P, Belagola Industrial Area K.R.S. Road, Metagalli, Mysore - 570 016
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
Perform
literature review activities when trained and 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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