Greetings from Technosoft Corporation!
Technosoft is an integrated Information Technology (IT) and Business Process Management (BPM) solutions provider. Our collaborative culture and work environment helps attract and retain exceptional talent which is a key ingredient to address our clients needs, and help drive our sustained growth. Our biggest differentiators include: A Focused Service Portfolio Customer-Centric Approach Outcome-Based Model Exceptional Talent Culture of Curiosity and Confidence Technosoft has approximately 3,600+ employees worldwide. Our global footprint spans across North America, India, UK, Australia and New Zealand, and the Middle East. Our vision is to be partner and employer of choice in our chosen segment. For more information, visit us at www.technosoftcorp.com
Specialties: IT Consulting, BPM services, Healthcare IT, Data Sciences, Mobility, Global In-house Centers, Professional Staffing.
We are hiring "Sr. Drug Safety Associate" in Technosoft, Mysore
Job Location: Mysore
Experience Range:2 yrs - 4 yrs
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.
- 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.
- 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.
If the above opportunity is of interest to you, do revert with your updated resume immediately along with the below details.
NOTE: Candidates from Chennai/Bangalore/Mysore need not to apply.
Relevant experience in "Drug Safety Associate" :
Reason for job change:
Official Notice Period:
How soon you can join:
Any clarifications please feel free to call me on the co-ordinates in my signature below / Email to : Arshad.Ay@technosoftcorp.com
Executive Talent Acquistion
Technosoft Global Services Pvt Ltd
Direct:8008600298 Board: 040-49428844 ! Extn : 831
"GO Beyond Possible"
Salary: INR Negotiable !!
/ Clinical Research
Functional Area: Medical
Role Category: Drug Regulatory Affairs/Documentation
Role: Documentation/Medical Writing
Employment Type: Permanent Job, Full Time