20 Eli Lilly Jobs

Graduate or post graduate in Pharmacy, Nursing or life sciences. Certification in Medical writing or Diploma in clinical research would be desirable. Preferred experience for the Author role: Preferably 1 to 2 years of experience in medical writing domain. Life science graduate with 1 to 3 years of experience Responsibilities of Author: 1. As per process requirement and assigned primary responsibility, support CSR patient narratives (draft and QC) 2. Ensure that the narratives are in accordance with the client SOPs, guidelines and agreed timelines and comply with client quality standards 3. Perform Quality check of the narratives according to the project specific checklist and against the source documents such as patient listing, concomitant medication listing, CIOMS form etc. and log defect in the defect tracker after analyzing the defect category 4. Attention to detail, work under stringent timelines on a need basis, and switch between different projects, as required 5. Be responsible for the quality and timelines of the deliverables as designated/allocated in the project. 6. Proactive communication with lead narrative writers to meet the narrative writing quality and timelines 7. Complete assigned training within stipulated timelines 8. Provide timely data (study tracker, quality metrics, billing numbers/effort hours) for preparing relevant (e.g. quality, TAT, effort hours, etc.) and project status updates, as defined by the client requirements Key Skills: a) Grad or PG in Nursing, Pharmacy or Life Sciences b) 1 to 2 years of experience in medical writing

Hi, We are hiring for ITES Company for SDTM Programmer Role. Job description: Minimum 2 years of experience for Senior Statistical programming is a mandate. • Having strong understanding of SAS Base/Macros/GTL and experience of SDTM/ADAM/TLFs creation as per CDISC standards. • Associate should be able to manage communication with customers, track and ensure quality on-time deliverables • Implementation of process improvements for enhanced quality and efficiency gains, institute robust processes to ensure consistent outcomes with quicker turn-around time. • Experience in SDTM, ADAM & TLF • Experience in EDC & VEEVA • Expertise in Base and Advance SAS programming. • Expertise in developing macros and developing generalized programs. • Development of the complex SAS macros that can be utilized across TAs in multiple studies, review of the developed SAS programs. • Expertise in SQL, SAS Macros, Functions, SAS GTL, SAS, and other advanced SAS components. • Mentor and supervise developers to build generic standard macros, generic listings or other ad-hoc requests in accordance with business requirements Key Skills: a) Minimum 2 years of Experience in SDTM, ADAM & TLF is must b) Any Graduate 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 ( Bangalore ) Type : Job Code # 91 b) To Apply for above Job Role ( Nagpur ) Type : Job Code # 92

Hi We are hiring for ITES Company for Spotfire Programmer Role. Responsibilities: Working on Refreshes requests for SRT & CSTV Building Oncology & Standard Visuals for Clinical Study Team Visualization (CSTV) Setting up standard and Study Specific requests for Safety Review Team (SRT) Knowledge of Spotfire, Study configuration tool and On Demand Tool. Creating SAS Codes as per the requirement Validation of visuals as per the specifications 1.5+ years of experience crafting interactive dashboards using TIBCO Spotfire. Adept at developing complex reports utilizing cross tables, bar charts, with advanced features like: property control, custom expressions, labels, and marking. Proficient in all core visualizations including bar charts, line charts, pie charts, scatter plots, cross tabs, and combination charts. Experience creating intricate dashboards leveraging information links and Iron Python scripting for enhanced functionality. Possess strong knowledge of advanced visualizations such as heat maps, box plots, tree maps, and map charts. Proven ability to collaborate effectively with stakeholders to address support requests and implement new feature enhancements. Skilled in publishing and deploying dashboards to meet specific business requirements. Proficient in Microsoft Excel functions including VLOOKUP, text functions, charts, and pivot tables. Demonstrated ability to handle multiple tasks simultaneously and thrive in both independent and collaborative work environments. Possess strong documentation and presentation skills to effectively communicate technical concepts. 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 # 78 b) To Apply for above Job Role ( Pune ) Type : Job Code # 79

Hi We are looking to hire for SAS+R Programming . Please go through the JD and Apply Roles & Responsibilities: Create data cleaning reporting solutions, study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. Contribute to process improvements and development of programming standards using R. Minimum of 3 years of experience in R programming including familiarity with R packages (e.g., Tidyverse, ggplot2, survival) Familiarity with data visualization techniques and tools in R. Write clean, efficient, and well-documented R code, conduct R code reviews, and R programming validation. Strong proficiency in R programming, including data manipulation, statistical analysis, and data visualization. Experience with POSIT Workbench, Connect, and/or Package Manager. Good to have python & SQL knowledge Develop library of reusable checks working closely with data engineers and config specialists. Collaborate with cross functional teams in creating business rules and automated check library across TAU. Serves as a technical resource for creating data analytics to help with data validation and cleaning. Provide programming expertise for data cleaning to efficiently ensure high quality data. Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 373 b) For Position in Pune Search : Job Code # 374

Hi, We are hiring for the leading ITES Company for EDC (Veeva & Inform Programmer) Role. JOB DESCRIPTION: Create eCRF specifications, design, develop and unit test and functionally validate clinical trial setup process Create edit check specifications and program or modify checks at study level within EDC Setup different instances of study URL (e.g.: UAT (User Acceptance Testing), production, testing etc.,) Setup and configure user accounts for study teams Setup and manage blinded and unblinded study configurations Be the SME (Subject Matter Expert) for all database related activities Setup, configure, unit test and functionally validate and integrate other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc., Familiar with custom functions within EDC systems Work closely with EDC vendors regarding any tool related issues in the system Ability to troubleshoot database setup as per study needs Prepare, test and implement postproduction changes as per study needs Archive and retire the study URL after database lock Partner with appropriate team members to establish technology standards and governance models • Establish and support business process SOPs. Oversee system delivery life cycle in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT (Information Technology), and Quality organizations Be a primary change agent to ensure adoption of new capabilities and business process Be the contact for Clinical Technology vendors to ensure established milestones are met with the highest degree of quality. Work with leaders to resolve issues affecting the delivery of clinical trials Collaborate with standards team in creating standard CRF libraries for study level consumption Work closely with data engineers and data management programmers at study level integration and delivery Lead technology vendor oversight activities. Be a process expert for operational and oversight models. 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 # 181 b) To Apply for above Job Role ( Pune ) Type : Job Code # 182 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 183

Hi We are hiring for ITES Company Role -Medical Reviewer Qualification : MBBS/MD only (MCI Certification is not mandate**) Experience Range : 1 to 7 Years Preferred Experience: Minimum of 1 years of experience in PV/ Clinical Research (drug safety) Job Description: Author a company clinical comment (CCC) for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: -Review and respond to any queries/comments from the Case Owner, which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database. -Detail any requests for changes to the case, including the narrative. -Detail any follow-up information that is required and not already noted within the Query Manager in the Patient Safety database. Provide product advice as required, especially with regards to case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Review the company causality assessment provided by Medical Advisor. • Review the medical sense including seriousness and coding of the case in the global context of the drug or clinical project, including the narrative, AE/SAE terms, suspect drugs, concomitant medications, laboratory data, and medical history. To provide documentation of the review and case comments in Sapphire in Medical Review workflow. Maintain knowledge of the marketed drug currently under litigation. Maintain knowledge of the company disease and therapeutic areas for marketed drugs and drugs in development through periodic medical review training held by client medical staff. Skills required: Computer Literate (good knowledge of MS Office) Sound understanding of the Drug Safety and Regulatory process Good problem solving and decision-making skills Capability to lead by motivation and example Ability to prioritize schedule and organize Excellent interpersonal and communication skills 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 # 47 b) To Apply for above Job Role ( Pune ) Type : Job Code # 48 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 51

Hi We are hiring for the leading ITES Company for the Medical Reviewer Role. Qualification - MBBS/MD is Must (Full TIme) Job Overview: The Medical Reviewer is responsible for the evaluation and analysis of clinical data to ensure accuracy, compliance with regulations, and the highest quality standards. This role involves reviewing clinical trial data, medical documentation, and regulatory submissions to support the approval of new medical products and therapies. Key Responsibilities: Clinical Data Review : Evaluate clinical trial data for completeness, accuracy, and adherence to protocols. Ensure data integrity and consistency across various documents and databases Medical Documentation: Review and verify the accuracy of medical documentation, including patient records, case reports, and clinical study reports. Ensure documentation complies with regulatory requirements and company standards. Regulatory Compliance: Stay updated with the latest regulatory guidelines and ensure all reviews align with current regulations. Prepare and review regulatory submissions to ensure timely and successful product approvals. Training and Development: Stay informed about advancements in medical research and regulatory changes. Participate in continuous training and development programs to enhance knowledge and skills. Skills required: Computer Literate (good knowledge of MS Office) Sound understanding of the Drug Safety and Regulatory process Good problem solving and decision-making skills Capability to lead by motivation and example Ability to prioritize schedule and organize Excellent interpersonal and communication skills 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 ( Pune ) Type : Job Code # 48 b) To Apply for above Job Role ( Chennai ) Type : Job Code # 52 c) To Apply for above Job Role ( Indore ) Type : Job Code # 53

Hi We are Hiring Leading ITES Company for Medical Reviewer Role. Please go through the JD and Apply Job Description: Author a company clinical comment (CCC) for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: -Review and respond to any queries/comments from the Case Owner, which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database. -Detail any requests for changes to the case, including the narrative. -Detail any follow-up information that is required and not already noted within the Query Manager in the Patient Safety database. Provide product advice as required, especially with regards to case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Review the company causality assessment provided by Medical Advisor. Review the medical sense including seriousness and coding of the case in the global context of the drug or clinical project, including the narrative, AE/SAE terms, suspect drugs, concomitant medications, laboratory data, and medical history. To provide documentation of the review and case comments in Sapphire in Medical Review workflow. Ensure compliance with global and local procedural documents and local implementation of client Maintain knowledge of the marketed drug currently under litigation. Maintain knowledge of the company disease and therapeutic areas for marketed drugs and drugs in development through periodic medical review training held by client medical staff. 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 ( Nagpur ) Type : Job Code # 49 b) To Apply for above Job Role ( Gandhinagar ) Type : Job Code # 50 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 51

We are Hiring for Leading ITES Company for Medical Reviewer Profile Pls Apply, We shall call back the relevant profiles. Experience :- Min 1 years of experience in Medical Reviewer domain Job Description for Medical Reviewer Author a company clinical comment (CCC) for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: -Review and respond to any queries/comments from the Case Owner, which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database. -Detail any requests for changes to the case, including the narrative. -Detail any follow-up information that is required and not already noted within the Query Manager in the Patient Safety database. Provide product advice as required, especially with regards to case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Review the company causality assessment provided by Medical Advisor. • Review the medical sense including seriousness and coding of the case in the global context of the drug or clinical project, including the narrative, AE/SAE terms, suspect drugs, concomitant medications, laboratory data, and medical history. To provide documentation of the review and case comments in Sapphire in Medical Review workflow. • Ensure compliance with global and local procedural documents and local implementation of client. Maintain knowledge of the marketed drug currently under litigation. Maintain knowledge of the company disease and therapeutic areas for marketed drugs and drugs in development through periodic medical review training held by client medical staff. Skills required: Computer Literate (good knowledge of MS Office) Sound understanding of the Drug Safety and Regulatory process Good problem solving and decision-making skills Capability to lead by motivation and example Ability to prioritize schedule and organize Excellent interpersonal and communication skills 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 # 47 b) To Apply for above Job Role ( Pune ) Type : Job Code # 48 c) To Apply for above Job Role ( Nagpur ) Type : Job Code # 49

Hi We are hiring for ITES Company Role -Medical Reviewer Qualification : MBBS/MD only (MCI Certification is not mandate**) Experience Range : 1 to 7 Years Preferred Experience: Minimum of 1 years of experience in PV/ Clinical Research (drug safety) Job Description: Author a company clinical comment (CCC) for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: -Review and respond to any queries/comments from the Case Owner, which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database. -Detail any requests for changes to the case, including the narrative. -Detail any follow-up information that is required and not already noted within the Query Manager in the Patient Safety database. Provide product advice as required, especially with regards to case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Review the company causality assessment provided by Medical Advisor. • Review the medical sense including seriousness and coding of the case in the global context of the drug or clinical project, including the narrative, AE/SAE terms, suspect drugs, concomitant medications, laboratory data, and medical history. To provide documentation of the review and case comments in Sapphire in Medical Review workflow. Maintain knowledge of the marketed drug currently under litigation. Maintain knowledge of the company disease and therapeutic areas for marketed drugs and drugs in development through periodic medical review training held by client medical staff. Skills required: Computer Literate (good knowledge of MS Office) Sound understanding of the Drug Safety and Regulatory process Good problem solving and decision-making skills Capability to lead by motivation and example Ability to prioritize schedule and organize Excellent interpersonal and communication skills To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Medical Reviewer Mumbai (Job Code # 47) b) For Position in Pune Search : Medical Reviewer Pune (Job Code # 48) c) For Position in Bangalore Search : Medical Reviewer Bangalore (Job Code # 51)

Hi We are hiring for the leading ITES Company for the Medical Reviewer Role. Qualification - MBBS/MD is Must (Full TIme) Job Overview: The Medical Reviewer is responsible for the evaluation and analysis of clinical data to ensure accuracy, compliance with regulations, and the highest quality standards. This role involves reviewing clinical trial data, medical documentation, and regulatory submissions to support the approval of new medical products and therapies. Key Responsibilities: Clinical Data Review : Evaluate clinical trial data for completeness, accuracy, and adherence to protocols. Ensure data integrity and consistency across various documents and databases Medical Documentation: Review and verify the accuracy of medical documentation, including patient records, case reports, and clinical study reports. Ensure documentation complies with regulatory requirements and company standards. Regulatory Compliance: Stay updated with the latest regulatory guidelines and ensure all reviews align with current regulations. Prepare and review regulatory submissions to ensure timely and successful product approvals. Training and Development: Stay informed about advancements in medical research and regulatory changes. Participate in continuous training and development programs to enhance knowledge and skills. Skills required: Computer Literate (good knowledge of MS Office) Sound understanding of the Drug Safety and Regulatory process Good problem solving and decision-making skills Capability to lead by motivation and example Ability to prioritize schedule and organize Excellent interpersonal and communication skills To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Chennai Search : Medical Reviewer Chennai (Job Code # 52) b) For Position in Indore Search : Medical Reviewer Indore (Job Code # 53)

Hi We are Hiring Leading ITES Company for Medical Reviewer Role. Please go through the JD and Apply Job Description: Author a company clinical comment (CCC) for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: -Review and respond to any queries/comments from the Case Owner, which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database. -Detail any requests for changes to the case, including the narrative. -Detail any follow-up information that is required and not already noted within the Query Manager in the Patient Safety database. Provide product advice as required, especially with regards to case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Review the company causality assessment provided by Medical Advisor. Review the medical sense including seriousness and coding of the case in the global context of the drug or clinical project, including the narrative, AE/SAE terms, suspect drugs, concomitant medications, laboratory data, and medical history. To provide documentation of the review and case comments in Sapphire in Medical Review workflow. Ensure compliance with global and local procedural documents and local implementation of client Maintain knowledge of the marketed drug currently under litigation. Maintain knowledge of the company disease and therapeutic areas for marketed drugs and drugs in development through periodic medical review training held by client medical staff. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Nagpur Search : Job Code # 49 b) For Position in Gandhinagar Search : Job Code # 50 c) For Position in Bangalore Search : Job Code # 51

We are Hiring for Leading ITES Company for Medical Reviewer Profile Pls Apply, We shall call back the relevant profiles. Experience :- Min 1 years of experience in Medical Reviewer domain Job Description for Medical Reviewer Author a company clinical comment (CCC) for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: -Review and respond to any queries/comments from the Case Owner, which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database. -Detail any requests for changes to the case, including the narrative. -Detail any follow-up information that is required and not already noted within the Query Manager in the Patient Safety database. Provide product advice as required, especially with regards to case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Review the company causality assessment provided by Medical Advisor. • Review the medical sense including seriousness and coding of the case in the global context of the drug or clinical project, including the narrative, AE/SAE terms, suspect drugs, concomitant medications, laboratory data, and medical history. To provide documentation of the review and case comments in Sapphire in Medical Review workflow. • Ensure compliance with global and local procedural documents and local implementation of client. Maintain knowledge of the marketed drug currently under litigation. Maintain knowledge of the company disease and therapeutic areas for marketed drugs and drugs in development through periodic medical review training held by client medical staff. Skills required: Computer Literate (good knowledge of MS Office) Sound understanding of the Drug Safety and Regulatory process Good problem solving and decision-making skills Capability to lead by motivation and example Ability to prioritize schedule and organize Excellent interpersonal and communication skills To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 47 b) For Position in Pune Search : Job Code # 48 c) For Position in Nagpur Search : Job Code # 49

Hi, We are hiring for the leading ITES Company for EDC (Veeva & Inform Programmer) Role. JOB DESCRIPTION: Create eCRF specifications, design, develop and unit test and functionally validate clinical trial setup process Create edit check specifications and program or modify checks at study level within EDC Setup different instances of study URL (e.g.: UAT (User Acceptance Testing), production, testing etc.,) Setup and configure user accounts for study teams Setup and manage blinded and unblinded study configurations Be the SME (Subject Matter Expert) for all database related activities Setup, configure, unit test and functionally validate and integrate other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc., Familiar with custom functions within EDC systems Work closely with EDC vendors regarding any tool related issues in the system Ability to troubleshoot database setup as per study needs Prepare, test and implement postproduction changes as per study needs Archive and retire the study URL after database lock Partner with appropriate team members to establish technology standards and governance models • Establish and support business process SOPs. Oversee system delivery life cycle in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT (Information Technology), and Quality organizations Be a primary change agent to ensure adoption of new capabilities and business process Be the contact for Clinical Technology vendors to ensure established milestones are met with the highest degree of quality. Work with leaders to resolve issues affecting the delivery of clinical trials Collaborate with standards team in creating standard CRF libraries for study level consumption Work closely with data engineers and data management programmers at study level integration and delivery Lead technology vendor oversight activities. Be a process expert for operational and oversight models. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 181 b) For Position in Pune Search : Job Code # 182 C) For Position in Bangalore Search : Job Code # 183

Hi, We are hiring for the leading ITES Company for EDC (Veeva & Inform Programmer) Role. JOB DESCRIPTION: Create eCRF specifications, design, develop and unit test and functionally validate clinical trial setup process Create edit check specifications and program or modify checks at study level within EDC Setup different instances of study URL (e.g.: UAT (User Acceptance Testing), production, testing etc.,) Setup and configure user accounts for study teams Setup and manage blinded and unblinded study configurations Be the SME (Subject Matter Expert) for all database related activities Setup, configure, unit test and functionally validate and integrate other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc., Familiar with custom functions within EDC systems Work closely with EDC vendors regarding any tool related issues in the system Ability to troubleshoot database setup as per study needs Prepare, test and implement postproduction changes as per study needs Archive and retire the study URL after database lock Partner with appropriate team members to establish technology standards and governance models • Establish and support business process SOPs. Oversee system delivery life cycle in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT (Information Technology), and Quality organizations Be a primary change agent to ensure adoption of new capabilities and business process Be the contact for Clinical Technology vendors to ensure established milestones are met with the highest degree of quality. Work with leaders to resolve issues affecting the delivery of clinical trials Collaborate with standards team in creating standard CRF libraries for study level consumption Work closely with data engineers and data management programmers at study level integration and delivery Lead technology vendor oversight activities. Be a process expert for operational and oversight models. To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 181 b) For Position in Pune Search : Job Code # 182 C) For Position in Bangalore Search : Job Code # 183

Hi We are hiring for ITES Company Role -Medical Reviewer Qualification : MBBS/MD only (MCI Certification is not mandate**) Experience Range : 1 to 7 Years Preferred Experience: Minimum of 1 years of experience in PV/ Clinical Research (drug safety) Job Description: Author a company clinical comment (CCC) for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: -Review and respond to any queries/comments from the Case Owner, which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database. -Detail any requests for changes to the case, including the narrative. -Detail any follow-up information that is required and not already noted within the Query Manager in the Patient Safety database. Provide product advice as required, especially with regards to case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Review the company causality assessment provided by Medical Advisor. • Review the medical sense including seriousness and coding of the case in the global context of the drug or clinical project, including the narrative, AE/SAE terms, suspect drugs, concomitant medications, laboratory data, and medical history. To provide documentation of the review and case comments in Sapphire in Medical Review workflow. Maintain knowledge of the marketed drug currently under litigation. Maintain knowledge of the company disease and therapeutic areas for marketed drugs and drugs in development through periodic medical review training held by client medical staff. Skills required: Computer Literate (good knowledge of MS Office) Sound understanding of the Drug Safety and Regulatory process Good problem solving and decision-making skills Capability to lead by motivation and example Ability to prioritize schedule and organize Excellent interpersonal and communication skills To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Medical Reviewer Mumbai (Job Code # 47) b) For Position in Pune Search : Medical Reviewer Pune (Job Code # 48) c) For Position in Bangalore Search : Medical Reviewer Bangalore (Job Code # 51)

We are Hiring for Leading ITES Company for Medical Reviewer Profile Pls Apply, We shall call back the relevant profiles. Experience :- Min 1 years of experience in Medical Reviewer domain Job Description for Medical Reviewer Author a company clinical comment (CCC) for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: -Review and respond to any queries/comments from the Case Owner, which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database. -Detail any requests for changes to the case, including the narrative. -Detail any follow-up information that is required and not already noted within the Query Manager in the Patient Safety database. Provide product advice as required, especially with regards to case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Review the company causality assessment provided by Medical Advisor. • Review the medical sense including seriousness and coding of the case in the global context of the drug or clinical project, including the narrative, AE/SAE terms, suspect drugs, concomitant medications, laboratory data, and medical history. To provide documentation of the review and case comments in Sapphire in Medical Review workflow. • Ensure compliance with global and local procedural documents and local implementation of client. Maintain knowledge of the marketed drug currently under litigation. Maintain knowledge of the company disease and therapeutic areas for marketed drugs and drugs in development through periodic medical review training held by client medical staff. Skills required: Computer Literate (good knowledge of MS Office) Sound understanding of the Drug Safety and Regulatory process Good problem solving and decision-making skills Capability to lead by motivation and example Ability to prioritize schedule and organize Excellent interpersonal and communication skills To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 47 b) For Position in Pune Search : Job Code # 48 c) For Position in Nagpur Search : Job Code # 49

Hi, We are hiring for leading ITES Company for Narrative Medical Writing Profile . Job Description Graduate or post graduate in Pharmacy, Nursing or life sciences. Certification in Medical writing or Diploma in clinical research would be desirable. Preferred experience for the Author role: Preferably 1 to 2 years of experience in medical writing domain. Life science graduate with 1 to 3 years of experience Responsibilities of Author: 1. As per process requirement and assigned primary responsibility, support CSR patient narratives (draft and QC) 2. Ensure that the narratives are in accordance with the client SOPs, guidelines and agreed timelines and comply with client quality standards 3. Perform Quality check of the narratives according to the project specific checklist and against the source documents such as patient listing, concomitant medication listing, CIOMS form etc. and log defect in the defect tracker after analyzing the defect category 4. Attention to detail, work under stringent timelines on a need basis, and switch between different projects, as required 5. Be responsible for the quality and timelines of the deliverables as designated/allocated in the project. 6. Proactive communication with lead narrative writers to meet the narrative writing quality and timelines 7. Complete assigned training within stipulated timelines 8. Provide timely data (study tracker, quality metrics, billing numbers/effort hours) for preparing relevant (e.g. quality, TAT, effort hours, etc.) and project status updates, as defined by the client requirements Key Skills: a) Grad or PG in Nursing, Pharmacy or Life Sciences b) 1 to 2 years of experience in medical writing To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Noida Search : Copy and Paste the link below https://outpace.in/job/narrative-medical-writing-4/

Hi We are looking forward to hire Medical Monitor for our Client. Please go through the JD and Apply Responsibilities: Review protocol and provide suggestions Respond to queries/ clarifications from EC/ IRBs Answer medical questions from sites or project team Respond to queries from sites with regard to protocol Attend drug safety meetings/ external meetings Patient eligibility review Review AE/ SAEs Protocol training to site staff, CRAs etc Attend, participate/ present in investigator meetings Qualification: MBBS/ MD qualification Eligibility: 3 year+ of clinical trial experience Familiar with clinical trials operations Good English communication skills Proficiency in using Microsoft office To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 362 b) For Position in Pune Search : Job Code # 363 c) For Position in Bangalore Search : Job Code # 364

Hi, We are hiring for ITES Company for SDTM Programmer Role. Job description: Minimum 2 years of experience for Senior Statistical programming is a mandate. • Having strong understanding of SAS Base/Macros/GTL and experience of SDTM/ADAM/TLFs creation as per CDISC standards. • Associate should be able to manage communication with customers, track and ensure quality on-time deliverables • Implementation of process improvements for enhanced quality and efficiency gains, institute robust processes to ensure consistent outcomes with quicker turn-around time. • Experience in SDTM, ADAM & TLF • Experience in EDC & VEEVA • Expertise in Base and Advance SAS programming. • Expertise in developing macros and developing generalized programs. • Development of the complex SAS macros that can be utilized across TAs in multiple studies, review of the developed SAS programs. • Expertise in SQL, SAS Macros, Functions, SAS GTL, SAS, and other advanced SAS components. • Mentor and supervise developers to build generic standard macros, generic listings or other ad-hoc requests in accordance with business requirements Key Skills: a) Minimum 2 years of Experience in SDTM, ADAM & TLF is must b) Any Graduate To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Bangalore Search : Job Code # 91 b) For Position in Nagpur Search : Job Code # 92