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Bengaluru
INR 20.0 - 25.0 Lacs P.A.
Hybrid
Full Time
Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation. Job Title: Assistant Manager/Manger - FP&A Location: Bengaluru Function: Finance ESSENTIAL DUTIES AND RESPONSIBILITIES: • Preparation of Monthly MIS report and other KPI Metrics • Develop and continually improve Budgeting, Financial projections and Operational forecasts. • Supporting during annual operation plan/Budget finalization. • Finance partnering with BU leaders and lead efforts to unpack BU profitability and drive analytics and decision support to improve profitability. • Tracking of various Operational and Financial KPIs (Variance Analysis, Project profitability, Utilization etc.) including but not limited to this. • Ensuring Revenue recognition in line with signed contracts • Ensuing Nil Revenue leakages on monthly basis • Working closely with the accounting team during month-end close to ensure costs and revenues are accrued wherever required. • Support during annual statutory audit regarding Revenue queries. • Tracking of Order Booking every week and working on Backlog forecast. • Ensuring Monthly invoicing in line with Contracts with mapping of right material code for revenue recognition and P&L reporting • Ad-hoc Analysis. • Implement a Business Intelligence tool and dashboard reports. • This role requires working with cross-functional teams like Legal (contracts), Sales, and other support functions to ensure a smooth flow of data for reporting and other analysis. • Handling of Automation projects for Finance EDUCATION AND EXPERIENCE REQUIRED: • 3-5 Years of FP&A core experience and MBA/CA or any other professional qualification preferred COMPENSATION & BENEFITS: Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits. EMPLOYMENT TYPE: Full Time, Permanent COMMITMENTS: • Standard Hours 40 hours per week, one hour lunch, Monday Friday. Additional hours as needed. • Willing to work in shifts as and when needed. DISCLAIMER: Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
Bengaluru
INR 18.0 - 20.0 Lacs P.A.
Hybrid
Full Time
Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation. Job Title: Senior Software Engineer Location: Bangalore, Karnataka ESSENTIAL DUTIES AND RESPONSIBILITIES Design, develop, test, debug, document software, and create /enhance existing components to ensure that software meets business needs Conduct design and code reviews to ensure code developed meets coding best practices guidelines, unit testing, security, and scalability and maintainability guidelines Deploy and maintain enterprise level Applications/Systems Collaborate with other team members, business stakeholders and product owners, both inside and outside the team Demonstrate application features and fixes with product management and users Mentor junior team members on procedures and technical standards Troubleshoot and support deployed systems Attend and participate in applicable company-sponsored training Maintain a strong understanding of software development trends and technology Maintain a strong understanding of the regulatory requirements applicable to software development in clinical trials EDUCATION AND EXPERIENCE REQUIRED: Bachelors degree in computer science, strongly preferred Minimum of 5+ years experience in - Angular with a WebAPI Backend - Experience with Microsoft SQL Server or SQL Azure. - Experience with an Agile development process - Experience with .net Framework and C# Strong interpersonal and communication skills, both verbal and written. Experience identifying and troubleshooting software problems. Strong organization skills and ability to prioritize and meet deadlines Experience conducting process re-engineering and improving costs/quality. COMPENSATION & BENEFITS: Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits. EMPLOYMENT TYPE: Full Time, Permanent COMMITMENTS: Standard Hours 40 hours per week, one hour lunch, Monday Friday. Additional hours as needed. Willing to work in shifts as and when needed. DISCLAIMER: Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
Bengaluru
INR 2.0 - 6.0 Lacs P.A.
Work from Office
Full Time
Job Title: Clinical Data Associate I (CDA I) Location: Bengaluru /Mysuru- Hybrid Function: Clinical Data Management ESSENTIAL DUTIES AND RESPONSIBILITIES The Clinical Data Associate I is responsible for working with the Clinical Data Management team and other internal project team members to provide data management services for our customers to ensure on time and accurate deliverables. Responsibilities include providing data management guidance to internal project team members and customers; communicating with internal project team members and customers on all aspects of data management activities performed for a study; authoring data management documents; performing user acceptance testing on data management deliverables; and facilitating and verifying data clarifications and data changes. Participating in the preparation/review of Data Management process control documents, including but not limited to the Data Management Plan, Data Validation Specification, User Acceptance Testing, Data Transfer Agreements/Specifications, External Reconciliation plans, SAE Reconciliation, CRF Completion Guidelines, etc. Effectively managing all data management aspects of assigned project(s) from set up to database lock. Participating in in-house and external training courses, as required. Having knowledge of Medidata Rave or any other EDC tool, and exposure to Business Object/JReview experience, which is an added advantage. Possessing knowledge of Clinical Protocol, data management plan, edit checks requirements, and data standards management. Producing project-specific status reports for management, PM, and/or clients on a regular basis and monitoring study metrics. Demonstrating strong verbal and written communication skills. Coordinating with the Medical Data Reviewer and/or Medical Monitor for the coding of medical terminology, as required. Demonstrating initiative and motivation. Being capable of directing and promoting teamwork in a multi-disciplinary team setting. Possessing excellent written and verbal communication skills. Having a strong knowledge of ICH guidelines. EDUCATION AND EXPERIENCE REQUIRED Preferably a life science graduate or equivalent qualification. 1-3 years of clinical data management experience within Contract Research Organizations (CRO), Pharmaceutical, or biotech industries. Effective working knowledge of Microsoft Office Suite, including Word and Excel. Demonstrated proactiveness, problem-solving, analytical, organizational, and time management skills. Demonstrated flexibility and ability to work well in a fast-paced, growing organization. Demonstrated ability to work in a global team environment. Demonstrates a basic understanding of Clinical Trials and the flow of data. Demonstrated ability to comply with ICH-GCP/ regional regulatory guidelines and Sitero SOPs. Comprehension of study documentation standards including Trial Master File organization and archival processes. Cross functional collaboration & Stakeholder management. COMPENSATION & BENEFITS Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits. EMPLOYMENT TYPE Full Time, Permanent COMMITMENTS Standard Hours 40 hours per week, one hour lunch, Monday - Friday. Additional hours as needed. Willing to work in shifts as and when needed. DISCLAIMER
Bengaluru
INR 16.0 - 20.0 Lacs P.A.
Hybrid
Full Time
Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation. Job Title: Automation Engineer Location: Bangalore Office Based (Hybrid Model) Function: Validation Services ESSENTIAL DUTIES AND RESPONSIBILITIES: Ensures software applications are accurate, complete and conform to all user, company and regulatory requirements by Planning, creating, and implementing automated verification processes. Creating associated validation documentation using proper documentation methods Assisting in the development and maintenance of automated testing procedures, processes, and quality standards Performing troubleshooting methods as necessary to maintain a stable and effective automated testing environment. Working with software developers and testers to resolve issues and retest applications. Evaluating and analyzing test results Participating in project team meetings as needed Updating automated test scripts by Identifying necessary automation techniques/tools Maintaining scripts and associated test matrices Identifying new areas for regression testing Maintains Quality Service and Departmental Standards by Reading, understanding and adhering to organizational Standard Operating Procedures (SOPs) Assisting in establishing and enforcing departmental standards including defining, documenting and implementing validation standards as needed Contributes to team effort by Performing code reviews and offer feedback on best coding practices when necessary. Offering technical and quality feedback/advice to both internal and external client. Working with internal staff including technical staff, project managers and applications developers to assist with the development of project specifications. Exploring new opportunities to add value to organization and departmental processes. Helping others to achieve results. Maintains Technical and Industry Knowledge by Attending and participating in applicable company-sponsored training EDUCATION AND EXPERIENCE REQUIRED: Education: Bachelors degree in Computer Science, Engineering, Life Sciences or related field required. Experience: 3+ years’ experience in validation/software testing required. Experience working with test automation development tools – such as Eclipse, Git, Java, Selenium, TestNG, Grid (and optionally CodedUI) preferred Experience working with computer software including Word, Excel and Teams preferred. API testing knowledge, familiarity with tools such as Postman, SoapUI preferred. 3+ years’ experience working with clinical trials and/or within pharmaceutical environment preferred. Working knowledge of the drug development process including knowledge of FDA requirements for GxPs and 21 CFR Part 11 preferred Proven problem-solving abilities. PREFERRED SKILLS: Ability to adjust to changing priorities. Strong understanding automated software QA methodologies. Excellent attention to detail and orientation toward careful meticulous work Must be highly motivated, result-oriented, and possess the ability to handle multiple projects with multiple deadlines concurrently with minimal supervision. Strong problem-solving, documentation and organizational skills Excellent oral and written communication skills Ability to project and maintain a professional and positive attitude. COMPENSATION & BENEFITS: Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits. EMPLOYMENT TYPE: Full Time, Permanent COMMITMENTS: Standard Hours 40 hours per week, one hour lunch, Monday – Friday. Additional hours as needed. Willing to work in shifts as and when needed. DISCLAIMER: Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
Bengaluru
INR 4.0 - 5.0 Lacs P.A.
Work from Office
Full Time
Job Title: Validation Analyst Location: Bangalore Function: Validation Services ESSENTIAL DUTIES AND RESPONSIBILITIES Plan, execute, and document software validation activities for both off-the-shelf and custom integrations in an FDA-regulated environment. Conduct comprehensive end-to-end validation of software integrations using tools such as Postman and SOAP UI to verify data accuracy, compliance, and system interoperability. Perform validation of AI-driven software integrations to ensure functionality, integrity, and regulatory alignment. Develop and execute validation test plans, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols, as well as test scripts and traceability matrices. Collaborate with cross-functional teams including Software Development, Quality Assurance, Regulatory Affairs, and IT to align validation activities with internal standards and external regulatory requirements. Utilize Azure DevOps for managing requirements, tracking test execution, and maintaining validation documentation. Validate software in cloud-hosted environments, ensuring compliance with security, performance, and data integrity standards. Participate in system risk assessments and contribute to the development of risk mitigation strategies. Ensure strict adherence to FDA 21 CFR Part 11, GxP, and other applicable regulatory guidelines throughout all validation processes. Document all validation efforts thoroughly and produce detailed reports to support internal reviews and external audits. Provide guidance and mentorship to junior validation analysts, promoting best practices and continuous improvement. EDUCATION AND EXPERIENCE REQUIRED: Education: Bachelor s degree in computer science, Engineering, or a related technical field. Minimum of 2-3 years of experience in API testing, Integration testing, and AI-driven solutions and workflows, preferably in a regulated industry. Experience: 2-3 years of hands-on experience in API testing, integration testing, and AI software validation, preferably within a regulated industry (e.g., life sciences, healthcare, or pharmaceuticals). Proficient in using Postman and SOAP UI for API and web service validation. Experience validating AI-driven solutions and workflows. Demonstrated expertise with Azure DevOps for test case management, execution tracking, and reporting. Solid understanding of cloud deployment models (IaaS, PaaS, SaaS) and best practices for validating applications in cloud environments. Familiarity with FDA regulations, including 21 CFR Part 11 and GxP, as well as risk-based validation methodologies. Strong knowledge of software development life cycles (SDLC) and validation life cycle processes, including Agile, Scrum, and SAFe frameworks. Excellent verbal and written communication skills, with the ability to collaborate effectively across cross-functional teams. Preferred Skills: Familiarity with continuous integration/continuous deployment (CI/CD) pipelines. Experience with database validation and data migration projects. Experience with API testing. COMPENSATION & BENEFITS: Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits. EMPLOYMENT TYPE: Full Time, Permanent COMMITMENTS: Standard Hours 40 hours per week, one hour lunch, Monday - Friday. Additional hours as needed. Willing to work in shifts as and when needed.
Bengaluru
INR 9.0 - 13.0 Lacs P.A.
Work from Office
Full Time
Job Description Company Overview Sitero is a leading organization specializing in clinical research and healthcare solutions. We are dedicated to advancing medical research and improving patient outcomes through innovative technologies and services. As we continue to grow, we are seeking a highly motivated and detail-oriented Lead Statistical Programmer to join our team and contribute to our mission. Position Overview The Lead Statistical Programmer will bring statistical programming and clinical expertise to the creation of SDTM and AdaM domains, as well as tabulations, graphics and listings derived from clinical trial data. Responsibilities include programming Data Management Listings in accordance with sponsor requirements, preparing, documenting and testing necessary programs and ensuring that programming code adheres to regulatory and company standards. The role also involves performing quality assurance on work done by others, supporting production activities and assisting in training new employees. Primary Responsibilities Provides data to clients (internal and external) in functional format by: Creating and executing SAS edit check programs Validating edit check programs using standard validation practices and processes Developing SAS programs that convert data from EDC to protocol-specific SAS datasets in accordance with customer specifications Assist with the creation of SAS-related project programming and validation documentation Assist with the creation of SAS macro and format libraries Ensures the quality of our clients data and data export by Reviewing and approving User Requirement Specifications (URS), Clinical Data Management (CDM) conventions, and working procedure documents Developing and implementing new CDM systems and enhancements to current CDM systems Understand, create, and communicate information about creating CDISC-compliant datasets Create documentation related to the generation of customer specific SAS datasets Maintain the SAS environment by providing assistance in SAS installation, updates, and maintenance Assist the Study Quality Representative in the testing of protocol specific SAS conversion programs Ensures project timelines as they relate to Clinical Data Management operations by Assessing and assigning target dates for project timelines in conjunction with manager Adhering to target dates for project timelines Communicating any changes in target date to appropriate personnel including Project Manager Keeping department head informed of current issues Maintains departmental productivity and identifies opportunities for greater departmental efficiencies and quality by: Coordinating activities of the Clinical Programming department with related activities of other departments (operations programming, study QA, PM and DM) to ensure efficiency Evaluating current procedures and work instructions for accomplishing department objectives in order to develop and implement improved procedures Assisting the training department with the development and maintenance of Clinical Programming training materials Secondary Responsibilities Contributes to team effort by Exploring new opportunities to add value to organization and departmental processes Helping others to achieve results Performing other duties as assigned and deemed necessary Maintains Technical Knowledge by Attending and participating in applicable company sponsored training Maintains Quality Service and Departmental Standards by Reading, understanding and adhering to organizational Standard Operating Procedures ( SOP ) Assisting in establishing and enforcing departmental standards Reviewing and providing recommendations to management on operational procedures, and participating in process improvement initiatives Qualifications Education Bachelor s degree in computer science, design or related field required Educational background in human-computer interaction, usability, user-centered design, user experience, information design, applied psychology, cognitive science, human factors, informatics, computer science, or other design/applied science fields is a plus. Experience 8+ Years of experience, SAS programming experience in pharmaceutical related industry - Required 5+ Years of experience, Experience working with CDISC, SQL, and Relational Databases - Required 3+ Years of experience, Understanding of database organization and how to extract data to generate listings and reports- Required Additional skill set Ability to work in group setting and independently; ability to adjust to changing priorities Excellent attention to detail and orientation toward meticulous work Strong interpersonal and communication skills, both verbal and written Strong documentation and organizational skills Ability to project and maintain a professional and positive attitude Working conditions Travel: 5-20% Lifting: 0-25 lbs Other: Computer work for long periods of time THIS POSITION DESCRIPTION SHOULD NOT BE DEEMED ALL INCLUSIVE. ADDITIONAL REQUIREMENTS AND EXPECTATIONS MAY BE ASSIGNED. AT ALL TIMES, EMPLOYEES ARE EXPECTED TO ADHERE TO COMPANY POLICIES AND COMPANY SOPS.
Mysuru, Bengaluru
INR 37.5 - 45.0 Lacs P.A.
Hybrid
Full Time
Company Overview Sitero is a leading organization specializing in clinical research and healthcare solutions. We are dedicated to advancing medical research and improving patient outcomes through innovative technologies and services. As we continue to grow, we are seeking a highly motivated and detail-oriented Lead Statistical Programmer to join our team and contribute to our mission. Position Overview The Lead Statistical Programmer will bring statistical programming and clinical expertise to the creation of SDTM and AdaM domains, as well as tabulations, graphics and listings derived from clinical trial data. Responsibilities include programming Data Management Listings in accordance with sponsor requirements, preparing, documenting and testing necessary programs and ensuring that programming code adheres to regulatory and company standards. The role also involves performing quality assurance on work done by others, supporting production activities and assisting in training new employees. Primary Responsibilities Provides data to clients (internal and external) in functional format by: Creating and executing SAS edit check programs Validating edit check programs using standard validation practices and processes Developing SAS programs that convert data from EDC to protocol-specific SAS datasets in accordance with customer specifications Assist with the creation of SAS-related project programming and validation documentation Assist with the creation of SAS macro and format libraries Ensures the quality of our client's data and data export by Reviewing and approving User Requirement Specifications (URS), Clinical Data Management (CDM) conventions, and working procedure documents Developing and implementing new CDM systems and enhancements to current CDM systems Understand, create, and communicate information about creating CDISC-compliant datasets Create documentation related to the generation of customer specific SAS datasets Maintain the SAS environment by providing assistance in SAS installation, updates, and maintenance Assist the Study Quality Representative in the testing of protocol specific SAS conversion programs Ensures project timelines as they relate to Clinical Data Management operations by Assessing and assigning target dates for project timelines in conjunction with manager Adhering to target dates for project timelines Communicating any changes in target date to appropriate personnel including Project Manager Keeping department head informed of current issues Maintains departmental productivity and identifies opportunities for greater departmental efficiencies and quality by: Coordinating activities of the Clinical Programming department with related activities of other departments (operations programming, study QA, PM and DM) to ensure efficiency Evaluating current procedures and work instructions for accomplishing department objectives in order to develop and implement improved procedures Assisting the training department with the development and maintenance of Clinical Programming training materials Secondary Responsibilities Contributes to team effort by Exploring new opportunities to add value to organization and departmental processes Helping others to achieve results Performing other duties as assigned and deemed necessary Maintains Technical Knowledge by Attending and participating in applicable company sponsored training Maintains Quality Service and Departmental Standards by Reading, understanding and adhering to organizational Standard Operating Procedures (SOP) Assisting in establishing and enforcing departmental standards Reviewing and providing recommendations to management on operational procedures, and participating in process improvement initiatives Qualifications Education Bachelors degree in computer science, design or related field required Educational background in human-computer nteraction, usability, user-centered design, user experience, information design, applied psychology, cognitive science, human factors, informatics, computer science, or other design/applied science fields is a plus. Experience 8+ Years of experience, SAS programming experience in pharmaceutical related industry - Required 5+ Years of experience, Experience working with CDISC, SQL, and Relational Databases - Required 3+ Years of experience, Understanding of database organization and how to extract data to generate listings and reports - Required Additional skill set Ability to work in group setting and independently; ability to adjust to changing priorities Excellent attention to detail and orientation toward meticulous work Strong interpersonal and communication skills, both verbal and written Strong documentation and organizational skills Ability to project and maintain a professional and positive attitude Working conditions Travel: 5-20% Lifting: 0-25 lbs Other: Computer work for long periods of time THIS POSITION DESCRIPTION SHOULD NOT BE DEEMED ALL INCLUSIVE. ADDITIONAL REQUIREMENTS AND EXPECTATIONS MAY BE ASSIGNED. AT ALL TIMES, EMPLOYEES ARE EXPECTED TO ADHERE TO COMPANY POLICIES AND COMPANY SOPS.
Bengaluru
INR 15.0 - 25.0 Lacs P.A.
Work from Office
Full Time
Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation. Job Title: Assistant Manager/Manger - FP&A Location: Bengaluru Function: Finance ESSENTIAL DUTIES AND RESPONSIBILITIES: Preparation of Monthly MIS report and other KPI Metrics Develop and continually improve Budgeting, Financial projections and Operational forecasts. Supporting during annual operation plan/Budget finalization. Finance partnering with BU leaders and lead efforts to unpack BU profitability and drive analytics and decision support to improve profitability. Tracking of various Operational and Financial KPIs (Variance Analysis, Project profitability, Utilization etc.) including but not limited to this. Ensuring Revenue recognition in line with signed contracts Ensuing Nil Revenue leakages on monthly basis Working closely with the accounting team during month-end close to ensure costs and revenues are accrued wherever required. Support during annual statutory audit regarding Revenue queries. Tracking of Order Booking every week and working on Backlog forecast. Ensuring Monthly invoicing in line with Contracts with mapping of right material code for revenue recognition and P&L reporting Ad-hoc Analysis. Implement a Business Intelligence tool and dashboard reports. This role requires working with cross-functional teams like Legal (contracts), Sales, and other support functions to ensure a smooth flow of data for reporting and other analysis. Handling of Automation projects for Finance EDUCATION AND EXPERIENCE REQUIRED: 3-7 Years of FP&A core experience and MBA/CA or any other professional qualification preferred COMPENSATION & BENEFITS: Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits. EMPLOYMENT TYPE: Full Time, Permanent COMMITMENTS: Standard Hours 40 hours per week, one hour lunch, Monday Friday. Additional hours as needed. Willing to work in shifts as and when needed. DISCLAIMER: Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
Bengaluru
INR 13.0 - 14.0 Lacs P.A.
Work from Office
Full Time
Medical Reviewer-Drug Safety Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation. Job Title : Medical Reviewer Location : Mysore-Hybrid Function : Drug Safety Services ESSENTIAL DUTIES AND RESPONSIBILITIES: Oversee overall Pharmacovigilance (PV) and risk management activities. Review all appropriate data for product specific reports. Provide draft and review (carried out by separate individuals) all single/aggregate/cumulative medical assessments/benefit risk assessments for safety reports. Provide medical oversight white creating draft reports based on the approved SOP/WI process. Coordinate internal review process and finalize draft reports from medical point of view. Assist medical writer in addressing all comments from client and finalize. Should review the finalized report even if participated in assisting medical writer. Provide expert guidance in PV and Aggregate reporting areas. Coordinate all post marketing regulatory reporting and PV activities for assigned products to be carried out by Sitero aggregate reporting team. Preparation of sections of medical significance/inputs for aggregate safety reports such as PSUR, PBRER, Periodic Adverse Drug Experience Report (PADER), Summary Bridging Report, Addendum to Clinical Overview, DSUR, RMP, and addendum to PSUR. Responsible for the medical assessment, recommendation, and conclusion section of the Aggregate Safety Reports. Prepare and review responses to adhoc regulatory queries. Appropriate scientific interpretation of relevant information for inclusion into drug safety documents, prepare and write analytical aggregate reports and other drug safety medical documents. Creating all documents in accordance with applicable Standard Operating Procedure (SOPs), conventions, and regulatory requirements. Planning, organizing, and managing daily work to meet service level timelines and deliverables. EDUCATION AND EXPERIENCE REQUIRED: 1-3 years experience in Clinical Practice required. 1+ yr of experience in Drug Safety and Pharmacovigilance in pharmaceutical or biotech company, CRO or regulatory agency within Drug Safety/Pharmacovigilance, with both investigational and marketed products is preferable. Medical Degree (MBBS or higher) from recognized medical school. COMPENSATION & BENEFITS: Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits. EMPLOYMENT TYPE: Permanent, Full Time COMMITMENTS: Standard Hours 40 hours per week, one hour lunch, Monday - Friday. Additional hours as needed. Willing to work in shifts as and when needed. DISCLAIMER: Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
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