Location : Remote Experience : 5+ years Employment Type : Contractual Role We are seeking an experienced Backend Developer with a strong background in Python and FastAPI. You will be responsible for designing, developing, and maintaining scalable backend systems, APIs, and server-side logic. The ideal candidate should have hands-on expertise in backend development, database optimization, and cloud platforms. Responsibilities Develop and maintain backend services using Python FastAPI Design and implement RESTful APIs and integrate third-party services Work with MySQL databases , design schemas, and optimize queries Ensure code quality, performance, and security through best practices Collaborate with cross-functional teams (DevOps, Product, UI/UX) to deliver high-quality solutions Debug, troubleshoot, and resolve backend production issues Write clean, maintainable, and well-documented code Required Skills & Qualifications 5+ years of experience in Python backend development Strong expertise in FastAPI Solid understanding of RESTful APIs, GraphQL, and microservices architecture Proficiency with database design, optimization, and ORMs Hands-on knowledge of Azure or other cloud platforms Familiarity with CI/CD pipelines, DevOps practices, and Agile methodologies Excellent problem-solving skills and attention to detail
Position: Computer System Validation (CSV) Consultant Experience: 3–5 years Department: Quality Assurance / Compliance Reporting To: QA Head Role Summary We’re looking for a skilled CSV Specialist to support validation and compliance of computerized systems in a regulated (GxP) environment. The role involves managing complete CSV lifecycle deliverables, ensuring alignment with GAMP 5, 21 CFR Part 11, Annex 11, and ICH guidelines. Prior experience with pharmacovigilance (PV) systems will be an added advantage. Key Responsibilities 1. System Validation & Documentation Prepare, review, and maintain all CSV deliverables — including Validation Plans, URS, FS/DS, Risk Assessments, Traceability Matrices, IQ/OQ/PQ protocols, and Validation Summary Reports . Ensure all validation follows the GAMP 5 lifecycle approach. Conduct periodic reviews, revalidation, and manage change control, CAPA, and deviation records. 2. Pharmacovigilance / Regulatory Systems Support validation of safety databases, signal detection tools, or regulatory submission systems. Maintain validated status of PV tools as per global regulatory expectations. 3. Compliance & Audit Readiness Ensure ongoing adherence to GxP, 21 CFR Part 11, Annex 11, and data integrity standards. Provide validation documentation and evidence during audits or inspections. Support system remediation and continuous compliance improvement activities. 4. Cross-Functional Collaboration Partner with QA, IT, Business, and Vendors to deliver validation milestones on time. Offer training and guidance on CSV practices and documentation standards. Monitor timelines and ensure deliverables meet project and quality requirements. Qualifications & Competencies Bachelor’s or Master’s in Life Sciences, Computer Science, Pharmacy, or related field. 3–5 years of direct experience in CSV within a GxP-regulated setting. Proficient with GAMP 5, 21 CFR Part 11, Annex 11, FDA/EMA, and ICH guidelines. Strong understanding of risk-based validation and SDLC (Agile/Waterfall). Experience with Pharmacovigilance systems preferred. Excellent documentation, analytical, and communication skills.
Job Title: Regulatory Affairs Manager Location: Remote Type: Full-time Experience: 7+ About the Role We are seeking an experienced Regulatory Affairs Manager to lead and oversee regional regulatory activities across global markets. This role requires strong leadership, strategic oversight, and hands-on expertise in regulatory submissions and health authority interactions. The ideal candidate will act as the primary interface between the sponsor and regulatory teams, ensuring compliance, efficiency, and excellence in all submission processes. Key Responsibilities Serve as the overall project lead and primary liaison with the sponsor. Provide strategic oversight of DSUR submissions , ensuring timely delivery and quality compliance. Manage communication and submissions with global Health Authorities (MOH, MFDS, TFDA, and others). Monitor and interpret regional regulatory updates to ensure continued compliance with evolving standards. Maintain a comprehensive regulatory intelligence repository for internal and client reference. Validate and confirm submission routes, formats, and requirements for each country or region. Qualifications & Requirements Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or Regulatory Affairs . 7+ years of experience in regulatory affairs, preferably within pharmaceuticals, biotech, or clinical research domains. Proven experience handling global regulatory submissions and coordinating with multiple health authorities. Strong understanding of ICH, FDA, EMA, and regional regulatory frameworks . Excellent communication, documentation, and stakeholder management skills. Ability to lead cross-functional teams and manage multiple projects simultaneously.
Manager, Drug Safety & PV Operations Location: On-Site, Ahmedabad Schedule: Full-time Experience: 6–8 years Roles Lead, develop, and mentor a team of PV professionals Act as the primary contact for drug safety queries across internal teams, distributors, affiliates, and authorities Steer decision-making related to PV operations, compliance, and safety risk management Oversee case management for both clinical and post-marketing safety Represent the PV function in cross-functional reviews related to patient safety, deviations, CAPA, and product quality Responsibilities Ensure alignment with FDA, EMA, ICH, and regional safety regulations Oversee timely case intake, assessment, and processing of AEs Escalate potential safety issues to Global Pharmacovigilance Direct literature surveillance activities and identification of reportable cases Lead audits and manage inspection readiness Deliver PV and regulatory training to build team capability Track compliance KPIs and communicate performance insights Drive process improvements to enhance PV systems and workflows Support Health Hazard Evaluations and CAPA activities Foster strong collaboration across internal and external stakeholders Qualifications 6–8 years of clinical/healthcare or safety-related experience 2–4 years of hands-on pharmacovigilance exposure (clinical or post-marketing) 4–6 years of team management experience Solid understanding of FDA/ICH safety reporting requirements Strong communication, analytical, and leadership skills Bachelor’s or Master’s in Pharmacy, Nursing, or Life Sciences (PV experience preferred)
Job Title: Safety System Analyst – Pharmacovigilance & Drug Safety Systems Location: Remote Type: Full-time Experience: 4-10 years Education: Bachelor’s Degree in Computer Science, Engineering, or related field About Us: We are seeking a highly skilled and experienced Safety System Lead or Senior Analyst to join our team. This is a leadership role within the pharmacovigilance and safety system management domain, where you will manage and optimize Drug Safety Systems for multiple clients. The ideal candidate is a proactive, highly organized professional with expertise in system configuration, safety report generation, and regulatory compliance. Key Responsibilities: Lead support, configuration, and maintenance of Drug Safety Systems for multiple clients, ensuring regulatory compliance. Mentor and lead a team of safety system analysts, providing guidance on complex system issues and optimization. Maintain strong client relationships, ensuring their requirements are met with high-quality service and timely solutions. Oversee the optimization of system performance, case processing workflows, and reporting functionalities. Manage integration of Drug Safety Systems with external systems, ensuring smooth data exchange via secure gateways and E2B import/export processes. Design, generate, and optimize Ad-hoc and Aggregate Safety Reports to ensure accuracy, compliance, and customization. Lead troubleshooting efforts and collaborate with IT teams or vendors as needed to minimize disruptions. Required Qualifications: 4-10 years of experience in pharmacovigilance, safety system administration, or related roles with hands-on Drug Safety Systems experience. Proven leadership experience in managing teams and client relationships while handling multiple clients. Extensive experience in generating and customizing Ad-hoc and Aggregate Safety Reports. Strong proficiency in Oracle SQL and PL/SQL for querying databases and generating reports. In-depth knowledge of pharmacovigilance regulations (e.g., ICH E2E, FDA, EMA) and their impact on safety system configurations. Experience integrating Drug Safety Systems with external systems and managing data import/export (E2B) processes. Bachelor’s degree in Computer Science, Engineering, or a related field.
Job description Job Title: Argus/ArisG Technology Experts – Pharmacovigilance & Drug Safety Systems Location: Ahmedabad Type: Full-time Experience: 4-10 years Education: Bachelor’s Degree in Computer Science, Engineering, or related field About Us: We are seeking a highly skilled and experienced Safety System Lead or Senior Analyst to join our team. This is a leadership role within the pharmacovigilance and safety system management domain, where you will manage and optimize Drug Safety Systems for multiple clients. The ideal candidate is a proactive, highly organized professional with expertise in system configuration, safety report generation, and regulatory compliance. Key Responsibilities: Lead support, configuration, and maintenance of Drug Safety Systems for multiple clients, ensuring regulatory compliance. Mentor and lead a team of safety system analysts, providing guidance on complex system issues and optimization. Maintain strong client relationships, ensuring their requirements are met with high-quality service and timely solutions. Oversee the optimization of system performance, case processing workflows, and reporting functionalities. Manage integration of Drug Safety Systems with external systems, ensuring smooth data exchange via secure gateways and E2B import/export processes. Design, generate, and optimize Ad-hoc and Aggregate Safety Reports to ensure accuracy, compliance, and customization. Lead troubleshooting efforts and collaborate with IT teams or vendors as needed to minimize disruptions. Required Qualifications: 4-10 years of experience in pharmacovigilance, safety system administration, or related roles with hands-on Drug Safety Systems experience. Proven leadership experience in managing teams and client relationships while handling multiple clients. Extensive experience in generating and customizing Ad-hoc and Aggregate Safety Reports. Strong proficiency in Oracle SQL and PL/SQL for querying databases and generating reports. In-depth knowledge of pharmacovigilance regulations (e.g., ICH E2E, FDA, EMA) and their impact on safety system configurations. Experience integrating Drug Safety Systems with external systems and managing data import/export (E2B) processes. Bachelor’s degree in Computer Science, Engineering, or a related field. Industry Research Services Employment Type Full-time
Job Title: Technology Argus/ArisG– Pharmacovigilance & Drug Safety Systems Location: Ahmedabad Type: Full-time Experience: 4-10 years Education: Bachelor’s Degree in Computer Science, Engineering, or related field About Us: We are seeking a highly skilled and experienced Safety System Lead or Senior Analyst to join our team. This is a leadership role within the pharmacovigilance and safety system management domain, where you will manage and optimize Drug Safety Systems for multiple clients. The ideal candidate is a proactive, highly organized professional with expertise in system configuration, safety report generation, and regulatory compliance. Key Responsibilities: Lead support, configuration, and maintenance of Drug Safety Systems for multiple clients, ensuring regulatory compliance. Mentor and lead a team of safety system analysts, providing guidance on complex system issues and optimization. Maintain strong client relationships, ensuring their requirements are met with high-quality service and timely solutions. Oversee the optimization of system performance, case processing workflows, and reporting functionalities. Manage integration of Drug Safety Systems with external systems, ensuring smooth data exchange via secure gateways and E2B import/export processes. Design, generate, and optimize Ad-hoc and Aggregate Safety Reports to ensure accuracy, compliance, and customization. Lead troubleshooting efforts and collaborate with IT teams or vendors as needed to minimize disruptions. Required Qualifications: 4-10 years of experience in pharmacovigilance, safety system administration, or related roles with hands-on Drug Safety Systems experience. Proven leadership experience in managing teams and client relationships while handling multiple clients. Extensive experience in generating and customizing Ad-hoc and Aggregate Safety Reports. Strong proficiency in Oracle SQL and PL/SQL for querying databases and generating reports. In-depth knowledge of pharmacovigilance regulations (e.g., ICH E2E, FDA, EMA) and their impact on safety system configurations. Experience integrating Drug Safety Systems with external systems and managing data import/export (E2B) processes. Bachelor’s degree in Computer Science, Engineering, or a related field.
Role Overview: You will be joining as a Safety System Lead or Senior Analyst in the pharmacovigilance and safety system management domain. Your primary responsibility will involve managing and optimizing Drug Safety Systems for multiple clients. As a proactive and highly organized professional, you will be expected to handle system configuration, safety report generation, and regulatory compliance efficiently. Key Responsibilities: - Lead support, configuration, and maintenance of Drug Safety Systems for multiple clients, ensuring regulatory compliance. - Mentor and lead a team of safety system analysts, providing guidance on complex system issues and optimization. - Maintain strong client relationships, ensuring their requirements are met with high-quality service and timely solutions. - Oversee the optimization of system performance, case processing workflows, and reporting functionalities. - Manage integration of Drug Safety Systems with external systems, ensuring smooth data exchange via secure gateways and E2B import/export processes. - Design, generate, and optimize Ad-hoc and Aggregate Safety Reports to ensure accuracy, compliance, and customization. - Lead troubleshooting efforts and collaborate with IT teams or vendors as needed to minimize disruptions. Qualification Required: - 4-10 years of experience in pharmacovigilance, safety system administration, or related roles with hands-on Drug Safety Systems experience. - Proven leadership experience in managing teams and client relationships while handling multiple clients. - Extensive experience in generating and customizing Ad-hoc and Aggregate Safety Reports. - Strong proficiency in Oracle SQL and PL/SQL for querying databases and generating reports. - In-depth knowledge of pharmacovigilance regulations (e.g., ICH E2E, FDA, EMA) and their impact on safety system configurations. - Experience integrating Drug Safety Systems with external systems and managing data import/export (E2B) processes. - Bachelors degree in Computer Science, Engineering, or a related field.,
Job Title: Regulatory Affairs Manager Location: Remote Type: Full-time Experience: 7+ About the Role We are seeking an experienced Regulatory Affairs Manager to lead and oversee regional regulatory activities across global markets. This role requires strong leadership, strategic oversight, and hands-on expertise in regulatory submissions and health authority interactions. The ideal candidate will act as the primary interface between the sponsor and regulatory teams, ensuring compliance, efficiency, and excellence in all submission processes. Key Responsibilities Serve as the overall project lead and primary liaison with the sponsor. Provide strategic oversight of DSUR submissions , ensuring timely delivery and quality compliance. Manage communication and submissions with global Health Authorities (MOH, MFDS, TFDA, and others). Monitor and interpret regional regulatory updates to ensure continued compliance with evolving standards. Maintain a comprehensive regulatory intelligence repository for internal and client reference. Validate and confirm submission routes, formats, and requirements for each country or region. Qualifications & Requirements Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or Regulatory Affairs . 7+ years of experience in regulatory affairs, preferably within pharmaceuticals, biotech, or clinical research domains. Proven experience handling global regulatory submissions and coordinating with multiple health authorities. Strong understanding of ICH, FDA, EMA, and regional regulatory frameworks . Excellent communication, documentation, and stakeholder management skills. Ability to lead cross-functional teams and manage multiple projects simultaneously.
Job Title: Argus Technology Experts – Pharmacovigilance & Drug Safety Systems Location: Ahmedabad Type: Full-time Experience: 4-10 years Education: Bachelor’s Degree in Computer Science, Engineering, or related field About Us: We are seeking a highly skilled and experienced Safety System Lead or Senior Analyst to join our team. This is a leadership role within the pharmacovigilance and safety system management domain, where you will manage and optimize Drug Safety Systems for multiple clients. The ideal candidate is a proactive, highly organized professional with expertise in system configuration, safety report generation, and regulatory compliance. Key Responsibilities: Lead support, configuration, and maintenance of Drug Safety Systems for multiple clients, ensuring regulatory compliance. Mentor and lead a team of safety system analysts, providing guidance on complex system issues and optimization. Maintain strong client relationships, ensuring their requirements are met with high-quality service and timely solutions. Oversee the optimization of system performance, case processing workflows, and reporting functionalities. Manage integration of Drug Safety Systems with external systems, ensuring smooth data exchange via secure gateways and E2B import/export processes. Design, generate, and optimize Ad-hoc and Aggregate Safety Reports to ensure accuracy, compliance, and customization. Lead troubleshooting efforts and collaborate with IT teams or vendors as needed to minimize disruptions. Required Qualifications: 4-10 years of experience in pharmacovigilance, safety system administration, or related roles with hands-on Drug Safety Systems experience. Proven leadership experience in managing teams and client relationships while handling multiple clients. Extensive experience in generating and customizing Ad-hoc and Aggregate Safety Reports. Strong proficiency in Oracle SQL and PL/SQL for querying databases and generating reports. In-depth knowledge of pharmacovigilance regulations (e.g., ICH E2E, FDA, EMA) and their impact on safety system configurations. Experience integrating Drug Safety Systems with external systems and managing data import/export (E2B) processes. Bachelor’s degree in Computer Science, Engineering, or a related field.