72 Parexel Jobs

Job Description: Active involvement in CAPA management activities within the team. Preferably must have faced Internal /Client audit. Working knowledge of the global pharmaceutical/pharmacovigilance regulations (ICH/ Good Pharmacovigilance modules) is preferable. Knowledge of TrackWise shall be an added advantage. Interpersonal and professional skills to interact at all levels including senior executives, contractors, and colleagues. Contribute to Global PV CAPA & Deviation Management implementation and documentation by completing all required processes as assigned. Audit & Inspection CAPA Management: 1. Collaborate with company departments/teams internal and external to provide oversight an...

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 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 (...

Role & responsibilities: 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 t...

Hi We are hiring for Leading ITES Company for Clinical Data Manager Profile. Role & responsibilities: Candidate should have 2-5 years of experience of CDM with experience in Conduct Scope of work Perform day-to-day Clinical Data Management activities. Experience in doing external data reconciliation Work and coordinate with the team to perform data management activities and deliver an error-free quality database in accordance with the data management plan and regulator standards. Read and understand the study protocol and the timelines. Perform test data entry in the TEST environment, data listing review, data reconciliation, and query management tasks. Escalate/Action discrepancy in the cli...

Hi We are Hiring for the job role of Medical Writer Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the information is scientifically sound,...

Hi We are Hiring for the job role of Medical Writer Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the information is scientifically sound,...

Hi, We are hiring for Leading ITES Company for Medical Writer Profile. Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the information is sc...

Hi Hiring for the leading ITES Company for Regulatory Medical Writer Profile. Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the informatio...

Hi, We are hiring for the Leading ITES Company for Medical Writing Role. Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the information is ...

Hi We are Hiring For Leading ITES Company for the position of PV Aggregate Reporting Role Job Description 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 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 t...

Hi We are hiring for Leading ITES Company for PV Aggregate Reporting Profile. Skills a) Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing b) Experience is documents i.e., PBRER,PSUR,DSUR, ICH Guidelines b) Qualifications - Health Care Professional OR Masters/bachelors degree in Life Sciences/Physician Job Responsibility Minimum 2 years of experience in Periodic/Scientific 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 ...

Hi We are hiring for Leading ITES Company for PV Aggregate Reporting Profile. Skills a) Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing b) Experience is documents i.e., PBRER,PSUR,DSUR, ICH Guidelines Job Responsibility Minimum 2 years of experience in Periodic/Scientific 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 To perform ...

Hi, We are hiring for Leading ITES Company for Lead Data Manager Profile. Job Description Perform day to day Clinical Data Management activities. Work and coordinate with the team to perform data management activities and deliver an error free quality database in accordance with the data management plan and regulator standards. Read and understand the study protocol and the timelines. Perform test data entry in TEST environment, data listing review, data reconciliation and query management tasks. Escalate/Action discrepancy in the clinical data as appropriate. Perform external checks to handle manual discrepancies and action the same. Ensure an error free, quality data with no open queries. ...

Hi , We are hiring for Leading ITES Company for SAS Programmer & CDB Programmer ( J Reviewer/Python/SAS) Role & responsibilities: 1.Create data cleaning reporting solutions study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. 2. Develop library of reusable checks working closely with data engineers and config specialists. 3. Collaborate with cross functional teams in creating business rules and automated check library across TAU. 4. Serves as a technical resource for creating data analytics to help with data validation and cleaning. 5. Provide programming expertise for data cleaning to efficiently ensure high quality data....

Hi We are hiring for the ITES Company for the SAS : J Review Programmer Role Role & responsibilities Programming, specifically Programming, specifically J Review, SQL, R and GitHub. Good to have SAS. Create data cleaning reporting solutions study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. 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 fo...

Hi, We are hiring for Leading ITES Company for Lead Data Manager Profile. Job Description Perform day to day Clinical Data Management activities. Work and coordinate with the team to perform data management activities and deliver an error free quality database in accordance with the data management plan and regulator standards. Read and understand the study protocol and the timelines. Perform test data entry in TEST environment, data listing review, data reconciliation and query management tasks. Escalate/Action discrepancy in the clinical data as appropriate. Perform external checks to handle manual discrepancies and action the same. Ensure an error free, quality data with no open queries. ...

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 mac...

Hi We are hiring for the ITES Company for the SAS : J Review Programmer Role Role & responsibilities Programming, specifically Programming, specifically J Review, SQL, R and GitHub. Good to have SAS. Create data cleaning reporting solutions study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. 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 fo...

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...

Hi, We are hiring for ITES Company for Spotfire Programmer Role. Job description: Minimum 3 years of experience as a Spotfire Programmer and Clinical experience is Mandatory Working on Refreshes requests for SRT & CSTV Building Oncology & Standard Visuals for Clinical Study Team Visualization (CSTV) Setting up standard and Study Specific Spotfire requests for Safety Review Team (SRT) Knowledge of Spotfire, Study configuration tool and On Demand Tool. Creating SAS Codes as per the requirement Setup and customization of visuals for Medical Reviewers Validation of visuals as per the specifications Optimize data models and queries for improved performance and scalability. Monitor and troubleshoo...

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 aggr...

Hi We are looking to hire Medical Data Reviewer for our Client. Please go through the JD and Apply. Responsibilities: Review subject/ patient level data for accuracy, to identify any anomalies, trends in patient reported data Review and provide inputs ion design of eCRF Review investigation product dosing Review all reported Adverse Events (AEs), Concomitant Medication and medical Ensure that any out of range data/ anomaly is verified Review all laboratory data on study subjects Review data in the form of visualizations and identify potential issues of concern Training new team members Qualifications: Bachelor/ Masters degree or equivalent in Life sciences/ Alternative Medicine (preferred) E...

Hi We are Hiring for the job role of Medical Writer Job Description: * Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. * Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. * Initiate start up meetings with the Study Teams related to the creation and development of the ...

We are Hiring For Leading ITES Company for the position of PV Aggregate Reporting Role Job Descriptions 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 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...

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 s...