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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 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 Call Handler Handles all product specific complaints/inquiries and listens to voicemail recordings Performs outbound call follow up to obtain missing or additional details. Enters PC/Inquires in Synowledge PC tools 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 submission activities when trained and assigned. Understanding and application of good documentation. 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 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 Years of Experience: 3 4 yearseducation: Qualified to Degree Level in Biosciences or an Appropriate Healthcare or Pharmaceutical Industry BackgroundCommunication 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 departmental 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,
Keyskills :
databaseadministration safety dataentry medicalcoding quality stronginterpersonalskills msoffice drugsafety followingup patientsafety medicalhistory workeffectively interpersonalskills pharmaceuticalindustry qms isms basic lunch tests