Jr. Drug Safety Associate
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.
• 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
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.
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.
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.
Standard Hours 40 hours per week, one hour lunch, Monday – Friday. Additional hours as needed.
Willing to work in shifts as and when needed
Bioclinica is an equal opportunity employer. Bioclinica evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.Collaboration, Continuous Learning, Critical Thinking, Organizational Awareness, Results Orientation, Service Orientation