Walk- In at
Bioclinica
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
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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