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.
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 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.
DESIRED TECHNICAL SKILLS:
Person should be familiar with MS Office Tools.
Safety database knowledge.
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.
Founded in 2006, Synowledge specializes in providing drug safety, regulatory affairs and... related IT services to small, mid, and large sized pharmaceutical, biotechnology and medical device companies. We are headquartered in Stamford CT, USA with operational facilities across the United Kingdom, Columbus, Ohio, and Bangalore, India. Our comprehensive outsourcing solutions combine the unique strengths of both onshore and offshore services to meet all of our clients’ pressing needs.
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