Senior Drug Safety Associate @ BIOCLINICA
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.
CLICK HERE ON LINK FOR
MORE DETAILS
GET UDYOG ADDA UPDATES EVERY TIME AND SHARE UPDATES WITH
JOB SEEKERS
No comments:
Post a Comment