Nupur

· Lead by being a subject matter expert.

· Skilled in Aggregate reports, Signal management and process and all related documents.

· Literature extraction, review & monitoring

· Validity / triage of cases, Dual Validity, Book-in, follow ups (by ARGUS, manual, postal etc)

· Work allocation to team members.

· Compliances management related to regulatory requirements.

· Provided new members with training and mentorship.

· Assisted in process improvement, productivity, and quality improvement by creating and updating company documents.

· Served as part of special projects lead for the organization.

· Proficient in Service level agreements.

· Maintenances of trackers related to clients and company, Work grids management, Metrices management.

· Communications related to company safety lead for monthly trend analysis.

· Proficient in listings extractions and review.

· Participated in monthly trend analysis for company products including cases listings & line listings and managed all the related trackers; Generation & quality review of Monthly trend analysis for 100+ molecules & trend analysis graphs.

· Archival (soft & hard copy) of documents as required by company policies

· Excellent tracking & delivery of work (Received recognition multiple times).

· Lead to the team of 16+ clients at once.

· Handled team of more than 70+ people at once.

· Managed Quality & productivity to maintain service level agreements.

· Involved in review & process development for the preparation of quality metrics, trending of work & error, work progress and maintenance of trackers timely delivery.

· Served as subject matter expert.

· Participated in process improvement team.

· Lead the team for update of project progress to the different stakeholders.

· Actively participated in direct Client dealing, response sharing, notifications & various other client activity including client interactions.

· Handled project initiation and was involved in implementation.

· Represented team in company meetings.

· Literature review & monitoring of various literature search.

· Maintenance of awareness of changes for new regulations affecting pharmacovigilance activities & for communicating new or changed regulations to management and to relevant members of the department to initiate any change in processes.

· Involved in Case Processing & quality review; All type of cases.

· Screening & initial preparation of literature search.

· Import of regulatory cases from AgXchange gateway & Eudravigilance

· Quality review of different type of CCF (case closure forms).

• Processed Cases; data entry for the Individual Case Safety Reports, Anonymized Single patient reports, Abstract case processing, AgXchange cases
• Preparation & quality check of Signal Report's data for the signals, Addendum Data Clinical Overview Reports, Periodic Adverse Drug Experience Reports, Safety Evaluation Reports, and Periodic Safety Update Reports for the Signal sections for all the molecules of Ranbaxy
• ICARE: Igniting Consciousness for Adverse Event Reporting (A learning module of Ranbaxy Pharmacovigilance to report Adverse Events); User Account Management & Generation of Certificates
• Trackers complying with required Regulations & according to Company's latest Standard Operating Procedures
• Documentation work of Signal documents & Anonymized Single patient reports source documents
• Updated & managed trackers.

• Backup Clinical research coordinator in a live trial (phase 3)
• Site Coordination / management issues & investigator issues/ site initiation visits/ Communication with Sponsor/CRO representatives
• Data Entry & validation of the entered data/ investigational products handling, including shipping of investigational products/ attended patient visits / Maintenance of temperature logbooks & patient logbooks, patient diaries, master Files & other related confidential documents including/ Handling & management of data with confidentiality/ Submitted reports to Ethics Committee
• Documented work related to trail & coordinated with the sponsor & monitor.