Samir Kumar Singh Email & Phone Number

Pune, Maharashtra, India

Do take care Work Flow of Cases. Preparing monthly dashboard. Handling of client escalation e-mail communication. Do work on monthly quality and productivity report. Do work on RCA for quality. Share regarding all new updates related to case processing with in the team. Process Clinical trial cases. Foster constructive and professional working relationships with all project team members, internal and external. File documents according to project specific requirements (electronically or in hard copy as applicable). Ensure case files are compliant with SOPs. Distribute safety data reports to other Sr. Safety Associate peer and Medical Monitor for review. Distribute safety data reports to clients and other relevant parties. Responsible for ensuring project deliverables are completed on time and with high quality. Ensure compliance with company policies, procedures, and standards. Participate in the development of safety SOPs and Operating Guides. Participate in project meetings. Participate in audits as required/appropriate. Interact and communicate effectively with other company departments/functions to ensure the highest level of client satisfaction through successful execution of projects. Lead in the development of case management related SOPs and Operating Guides. Assist with preparation/compilation, and review of safety aggregate reports. Responsible for distributing and monitoring team workload. Provide support for Safety Lead with miscellaneous project tasks related to case management. Mentor and train other associates on processes regarding case processing. Perform literature review as appropriate for Post-Marketing cases. Communicate with other departments and clients as directed by project lead to ensure compliance with safety and PV SOP’s. Maintain knowledge of all applicable FDA/EU/ICH guidelines and regulations relating to safety and PV reporting. Any other duties as assigned by manger.

Pune, Maharashtra, India

Bengaluru, Karnataka, India

Responsible for translation from Eng. to Japanese of individual case safety database including medical coding and safety narrative.Evaluate case information to determine required action on the case based on following application policies and procedures.Process all incoming cases in order to meet time lines.Review data entered in safety database for completeness and accuracy.Provide quality feedback to team resources.Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various field.

Bengaluru, Karnataka, India

Receiving orders for Japan Hardware Quoting and Configuration product from Japanese client and processing them further by understanding the terms and requirements of the customer and delivered on time.Involves in translation of orders as they written in Japanese, contacting the sales department based in japan via telephone/e-mail and fixing the orders.Good experience working closely with the Japanese customer as the job involves daily telephonic/written communication with Japanese customers/sales.Assigning the request equally among the team members, monitoring the queue and monitoring on the floor to address their concerns.Handling escalations, QC, RCA(Route cause analysis)and all the process related queries and taking call on urgent and escalated request.Maintaining and circulating the production reports to the higher management on daily basis.Suggested and successfully implemented process enhancement ideas to improve the quality, reduce the processing time and increasing productivity.Received lots of appreciation mail from the sales for the delivered on time without getting any error.Received YAR award is the given for the Volume Reports, Quality, Customer Appreciations and additional responsibilities.

Gurugram, Haryana, India

Technical interpretation related to leak testing machine at our end and customer site.Visiting existing customer as well as new customer.Receive inquiry and make quotation.Follow up with customers till the project completion.Cope-up in extreme pressure and within deadline for complete the target.Keep records update of customer and projects for our internal use.Provide service support to customer as per requirement.Doing admin. work ( arrangement of taxi, hotel & flight booking for Japanese). Four months training in Cosmo Instruments India Pvt. Ltd., Japan.Technical training on machine side.Visited customer sight for the improve client relationship.Training for preparing the documents for expert-import.Training for managing data in Excel.

Bachelor, Arabic Language

Bachelor, Science Stream

Master, Marketing