Bioclinica Walk- In Jr Drug Safety Associate 22nd Feb 2020 B Pharmacy, M Pharmacy, Pharm D, BDS, MDS, BSc Nursing, MSc Nursing
Day, Date: Saturday, 22nd Feb 2020
Time: 9 AM to 1 PM
Venue:
Bioclinica, ABBHI Campus, #120 P- 122P,
Belagola Industrial Area, K R S Road,
Metagalli, Mysore - 570 016
Job Title: Jr Drug Safety Associate
Location: Mysore
Years of Experience: 0 to 1 years
Education: B Pharmacy, M Pharmacy, Pharm D, BDS, MDS, BSc
Nursing, MSc Nursing
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 with regulatory &pharmacovigilanceguidelines.
· 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.
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