PLEASE NOTE : BIOCLINICA IS CONDUCTING THIS WALKIN INDEPENDENTLY AND NOT WITH PARTNERSHIP WITH CONSULTANCIES.
Bioclinica invites you for an opportunity to be part of our Pharmacovigilance team!
Meet us on Saturday, 9th Feb 2019 between 11 AM to 1 PM at the below address:
Bioclinica India Pvt Ltd
No: 18/2 & 18/3, V G Heritage,
Vani Vilas road, Basavanagudi, Bangalore
JOB TITLE: Sr Drug Safety Associate
WORK LOCATION: Mysore, India
YEARS OF EXPERIENCE: 1 to 4 years of experience in PV (Pharmacovigilance)
EDUCATION: Health care professional or Any Equivalent Degree (BPharm/B Sc nursing/BPT/BDS/MBBS/BHMS/BAMS etc)
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.
As Narrative Writer
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.
Relevant product and industry knowledge.
Experience with relevant software applications.
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.
Time and Venue
9th February , 11 AM onwards
Bioclinica India Pvt Ltd No:18/2 &amp; 18/3, V G Heritage, Vanivilas Road, Kanakapura, Basavanagudi, Bengaluru, Karnataka 560004