Clinical trials are complex and monolithic approaches are the norm. But the most successful trials require the ability to see key details and uncover hidden insights. Bioclinica creates clarity in the clinical development process, and we are looking for passionate professionals who are ready to share their knowledge and innovation to support successful clinical trials.
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Position: Sr Drug Safety Associate
Location: Mysore, Karnataka, India
Essential Duties and Responsibilities:
As Case Intake Member:
- Responsible for case intake, duplicate check, and registration
- Maintain a 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.
- Following up with sites regarding outstanding queries.
- Follow up on the reconciliation of discrepancies.
- Follow departmental AE workflow procedures.
- Closure and deletion of cases.
- Mentor and guide the activities of the Drug Safety Associate.
- High level of proficiency at 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:
- The 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.
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