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Job Location | Mysore |
Education | Not Mentioned |
Salary | Not Disclosed |
Industry | Pharma / Biotech |
Functional Area | General / Other Software |
EmploymentType | Full-time |
Essential Duties And Responsibilities: As Quality Check Reviewer &Bull;Review Data Entered In Safety Database For Completeness And Accuracy. &Bull;Provide Quality Feedback To Team Resources &Bull;Track And Maintain Quality Metrics As Case Processor &Bull;Responsible For Data Entry Of Individual Case Safety Reports Into The Safety Database. &Bull;Review And Evaluate Ae Case Information To Determine Required Action Based On And Following Internal Policies And Procedures. &Bull;Process All Incoming Cases In Order To Meet Timelines. &Bull;Full Data Entry Including Medical Coding And Safety Narrative. As Medical Coder &Bull;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 &Bull;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: &Bull;Following Up With Sites Regarding Outstanding Queries. &Bull;Follow Up On Reconciliation Of Discrepancies. &Bull;Follow Departmental Ae Workflow Procedures. &Bull;Closure And Deletion Of Cases. &Bull;Mentor And Guide The Activities Of The Dug Safety Associate. &Bull;High Level Of Proficiency Al All Workflow Tasks. &Bull;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.,
Keyskills :
caseprocessing pharmacovigilance safety case dataentry stronginterpersonalskills msoffice drugsafety followingup qualitycheck medicalcoding patientsafety oliciesprocedures medicalhist keffect