7 Argus Safety Jobs

Their responsibilities include reviewing safety data, identifying potential safety signals, assessing causality, and providing guidance on risk management and communication. Key Responsibilities: Safety Data Review and Analysis Risk Management and Communication Regulatory Compliance Qualifications Bachelor's or Masters degree in a related field, such as Medicine, pharmacy or related field 0-2 years of experience in related field Strong analytical and problem-solving skills Excellent communication and interpersonal skills Ability to work independently and as part of a team Interested to apply can share CV or call/whatsapp to 9342735755

Ultragenic brings together Life sciences domain expertise, Third party system knowledge and Deep technology to develop well-defined solutions, which address challenges across the Pharmacovigilance function. Our solutions are agile, flexible and scalable, developed using advance technologies such as AI, Machine learning and Robotic process automation that enable us to serve large and small organizations, both in developed and emerging markets. With rich experience in engineering and deploying best-in-class life sciences solutions, our team is well placed to help achieve your goals. Skills Experience of design, development and deployment of multi-dimensional reports using any BI Tool preferably Cognos/OBIEE/Quicksight/Logi/Tableau, Business Intelligence solution. Experience in Oracle PL/SQL and writing efficient SQL queries. Experience of creating excel based and RTF template based OBIEE Reports is a plus. Good experience in database concepts, and any ETL tool is added advantage. Good understanding of DW concepts and Analytical skills. Good experience in Performance tuning to ensure reports function within acceptable parameters. Good to have pharmacovigilance domain exposure. Responsibilities Work with business users to design and develop Custom Reports using any BI Tool preferably Cognos/OBIEE/Quicksight/Logi/Tableau, Business Intelligence solution. Prepare all designs and code for various Custom Reporting objects and ensure compliance with all best business practices in the industry. Understand business requirements, relational databases, and data models. Authoring of installation specifications and execution of unit testing. Be responsible for authoring project documentation/deliverables. Facilitate/contribute to client demo sessions/workshops.

Hi We are Hiring for ITES Company for the Pharmacovigilance Aggregate Reporting Role Job Description: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic Aggregate Safety Reports (PBRER, DSUR etc.) To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation. Drafting and maintaining PV agreements and SDEA'S Workflow management along with case allocation Accountable for updating relevant databases, repositories, trackers and logs on an ongoing basis as per relevant SOPs Submission of cases to various regulatory Authorities (EMA, MHRA, FDA, Health Canada) Execute drug safety data management process- a combination of case intake, triage, case entry, medical coding, narrative writing, peer review, case follow-up, report preparation- with accountability for quality and timelines of deliverables and responsibility for process improvements Maintaining and drafting project level SOPs as per Statement of Work. Create/collate periodic reports for client report meetings. To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 54 b) To Apply for above Job Role ( Pune ) Type : Job Code # 55

I am sharing with you the details related to the profile and the company below and kindly acknowledge this email with your updated resume: Company website : https://ultragenicglobal.com/ Company LinkedIn Page : https://www.linkedin.com/company/ultragenic/mycompany/?viewAsMember=true Job Description for Argus Config. : Should have good understanding of the Pharmacovigilance/ Health Care domain. Should have excellent knowledge of Oracle Argus Safety/LSMV or other PV/Safety systems. Should have experience in installing/configuration/validation of Argus Safety and customizations. Should have good knowledge of SQL, PL/SQL. Should have experience in configuring reports in Argus Aggregate and Periodic reports. Should have experience in Regulatory Standards like 21 CFR Part 11, ICH, GxP. Should have experience in Argus Business and system configuration. Should be able to provide technical architecture and design as per the user requirements. Should have experience in performing System Integration and User Acceptance testing as part of upgrade/ implementation projects. Should have good understanding of regulations (EU, FDA, MFDS, NMPS, Mexico, Taiwan and Russia). Thanks & Regards, Tripti Kumari Associate Principal - HR tripti.kumari@ultragenicglobal.com

Company Name: IQVIA Experience: 5+ Years Location: Ahmedabad/Kolkata (Hybrid Model) Interview Mode: Virtual Interview Rounds: 2-3 Rounds Notice Period: Any Generic description: Your primary responsibility will be validating and quality checking safety database fields on assigned projects. You will also provide input for and review relevant safety tracking systems for accuracy/quality and perform safety review of clinical data (case report forms) and patient labs. You will have knowledge of drug safety databases, preferably ARGUS. You will have the ability to produce high quality work, with meticulous attention to detail. You will be fluent in verbal and written English, with excellent communication skills.

Hi We are Hiring for ITES Company for the Pharmacovigilance Aggregate Reporting Role Job Description: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic Aggregate Safety Reports (PBRER, DSUR etc.) To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation. Drafting and maintaining PV agreements and SDEA'S Workflow management along with case allocation Accountable for updating relevant databases, repositories, trackers and logs on an ongoing basis as per relevant SOPs Submission of cases to various regulatory Authorities (EMA, MHRA, FDA, Health Canada) Execute drug safety data management process- a combination of case intake, triage, case entry, medical coding, narrative writing, peer review, case follow-up, report preparation- with accountability for quality and timelines of deliverables and responsibility for process improvements Maintaining and drafting project level SOPs as per Statement of Work. Create/collate periodic reports for client report meetings. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : PV Aggregate Mumbai (Job Code # 54) b) For Position in Pune Search : PV Aggregate Pune (Job Code # 55)

Hi We are Hiring for ITES Company for the Pharmacovigilance Aggregate Reporting Role Job Description: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic Aggregate Safety Reports (PBRER, DSUR etc.) To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation. Drafting and maintaining PV agreements and SDEA'S Workflow management along with case allocation Accountable for updating relevant databases, repositories, trackers and logs on an ongoing basis as per relevant SOPs Submission of cases to various regulatory Authorities (EMA, MHRA, FDA, Health Canada) Execute drug safety data management process- a combination of case intake, triage, case entry, medical coding, narrative writing, peer review, case follow-up, report preparation- with accountability for quality and timelines of deliverables and responsibility for process improvements Maintaining and drafting project level SOPs as per Statement of Work. Create/collate periodic reports for client report meetings. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : PV Aggregate Mumbai (Job Code # 54) b) For Position in Pune Search : PV Aggregate Pune (Job Code # 55)