Walk-In for Freshers & Experienced @ our Bangalore office on 3rd Nov, 2018 (Saturday)
This role is into Pharmacovigilance domain and the walk-In timings are in between 9 AM – 1 PM.
Walk-In Venue:
Bioclinica India Pvt. Ltd,
#18/2 & 18/3, V G Heritage,
Vanivilas road,
Basavanagudi,
Bangalore.
Kindly go through the job description and walk-in with your updated resume.
JOB TITLE: Drug Safety Associate
LOCATION: Mysore, India
YEARS OF EXPERIENCE: 0 to 2 years
EDUCATION: Any Health care professional (BPharm/M Pharm/ Pharm D/B. Sc Nursing / BPT / BDS / BHMS / BAMS etc.)
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.
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.
Willing to work in shifts as and when needed
