SANDEEP KUMAR

To obtain a challenging a reputed organization like yours, which can provide adequate opportunities and environment position in to enrich my knowledge, envisage career growth and to do my best with honesty and diligence for the growth of the organization. Reliable Quality Control Specialist with abilities in blueprint interpretation, operations monitoring and quality control inspections. Outstanding communication, active listening, and organizational talents. Physically fit and adaptable with the capability to work in various work environments. Logical Pharmacovigilance experts with background identifying, assessing and preventing adverse effects or medications, vaccines and related pharmaceutical items. Dedicated expert with focus on maintaining drug safety by preparing and reviewing data and reports. Meticulous when authoring professional documents and reviewing scientific literature.

• Father's Name: Sh. Bijender Pal Singh
• Notice Period: 3 months
• Date of Birth: 05/23/87
• Nationality: Indian
• Marital Status: Married

• Currently working as Quality control of ICSRs in Argus for case processing of spontaneous, patient support program, market research program, non-interventional study, license partner, pregnancy, literature, regulatory authority, clinical trials, drug device combination products and other study cases for antiepileptic drugs, biological drugs for psoriasis, psoriatic arthropathy, osteoporosis, myasthenia gravis, diabetic drug domain.
• Working as subject matter expert (SME) for case processing team providing them guidance and query resolution.
• Providing mentorship to new associates on case processing convention on Argus as per client SOP guidelines.
• Maintaining training compliance, maintaining and approving leave for 8-10 associates.
• Creating and maintaining and tracking RCA and CAPA for the team.
• Reviewing and updating all the fields in Argus, Medra coding of events case assessment, labeling, Narrative generation and case correction, query generation for taking follow-up of patient information in Argus
• Worked on EMA-CP case processing of ICSR for regulatory authority on EVWEB for Covid vaccines for EU countries.
• Quality control of ICSRs under EMA Data Management Process in which ICSRs submitted to the regulatory has been thoroughly check for each section (Patient identifier, Drug, Event, Lab test, Reporter, Narrative, Medra coding of event) and correcting the ICSRs if required and providing report of quality ICSRs to the EMA.
• Duplicate Detection and merging of duplicate ICSRs and creating a master file of ICSRs that contain all the information of underline ICSRs, and also updating the master file for any follow-up information of ICSRs in the Duplicate detection Client database on EMA project
• Performed literature research and analysis of the data for other for Periodic safety update report (PSUR) and Signal detection.
• Data Entry in Art 57 database (Xevmpd database) in Eudravigilance for EU clients. Update of SmPC, withdrawal of products from Xevmpd database, update of New Grant of products in various EU countries in Xevmpd database.
• Literature monitoring of Embase and Pubmed searching database for the identification of valid and Potential ICSRs and using this data for the scientific and business research maintenance of compliance for all EU clients for submitting products as per regulatory guidelines in Eudravigilance database.

• Injectable and ophthalmic department, Jubilant Life science limited, D-12, Sector 59, Noida, Uttar Pradesh, 6 months
• Manufacturing of Contact Lens Solution & Eye Drop, Gaymed Lab Pvt. Ltd., Fatehpuri, Delhi, 1 month
• Pharmacist, E.S.I. Hospital, Okhla, 500 hours

• Pharmacovigilance
• Data analysis
• Secondary research
• Life sciences
• Drug regulatory

GPAT qualified

Registered pharmacist delhi