ICH Jobs in Bengaluru

Job Title: R&D Scientist Validation, Fast Trak Process Design & Validation Services Location: Bengaluru, India About the Role: We are looking for an R&D Scientist Validation to support the design, execution, and validation of new or improved services as part of our R&D strategic plan. This role will focus on validation services across the bioprocessing portfolio and involves working from early concept development through testing and final implementation. The position also contributes to lab and facility setup and ensures all necessary documentation is in place for successful service launches. Key Responsibilities: Provide technical support on innovation and development projects, collaborating with R&D project managers and cross-functional teams to ensure timely and efficient delivery. Assist in defining technical requirements based on customer and market needs to guide new service/product development. Help plan, assess risks, execute, and document technical studies at different stages of project development. Design and execute verification and validation studies to confirm alignment of service/product outputs with technical and marketing specifications. Support laboratory operations and ensure adherence to Environment, Health & Safety (EHS) standards and regulatory compliance. Qualifications: Bachelor s, Master s, or Ph.D. in Molecular Biology, Biochemistry, Bioengineering, or a related scientific field. Minimum of 3 years of experience supporting or leading technical projects within an R&D or bioprocessing environment. Strong problem-solving skills with a proactive, solution-oriented mindset and ability to work independently. Comfortable managing multiple projects simultaneously in a dynamic environment. Effective reporting and presentation skills, with the ability to tailor communication to various audiences. Preferred Experience: Familiarity with aseptic techniques and laboratory best practices. Working knowledge of Good Laboratory Practice (GLP) and scientific method principles. Qualification : Bachelors, Masters, or Ph.D. in Molecular Biology, Biochemistry, Bioengineering, or a related scientific field.

Medical Review Physician 1 Location: Bengaluru Employment Type: Full-Time About the Role We are seeking a detail-oriented and experienced Medical Review Physician to join our pharmacovigilance team in Bangalore. In this role, you will be responsible for the medical evaluation of individual case safety reports (ICSRs) across multiple data sources and therapeutic areas, ensuring compliance with global regulatory standards and internal quality benchmarks. Key Responsibilities Medical Review & Safety Assessment Perform medical review of both serious and non-serious ICSRs, with a focus on seriousness, expectedness, causality, and narrative quality. Review ICSRs originating from multiple sources: spontaneous reports, literature, regulatory authorities, solicited sources, and clinical trials. Evaluate and verify the selection of adverse events from source documents, assign appropriate MedDRA codes, assess product labelling, and review narratives for accuracy and completeness. Support triage activities and determine seriousness and relatedness across assigned products. Product & Process Expertise Maintain up-to-date knowledge of product portfolios and safety profiles across therapeutic areas, including Oncology, Respiratory, Immunology, Neuroscience, and Rare Diseases. Ensure timely completion of all medical review activities in line with regulatory timelines and service level agreements (SLAs). Contribute to process improvement initiatives, including implementation of quality control checks and feedback mechanisms. Collaboration & Training Provide expert medical guidance to case processors, data entry associates, and quality reviewers to address queries and discrepancies. Mentor and train team members in GVP concepts, case processing standards, and disease-specific medical knowledge. Collaborate with internal functional teams and client therapeutic groups to resolve case-related issues efficiently. Compliance & Quality Stay updated with ICH-GCP, GVP modules, 21 CFR, and other relevant regulatory guidelines. Deliver consistent, high-quality output while ensuring compliance with client-specific conventions and global safety standards. Take on additional tasks as assigned by the team lead/manager, adapting to shifting business priorities when necessary. Candidate Profile Education: MBBS or MD is required. Experience: 2 4 years of hands-on experience as a Medical Reviewer for ICSRs. Regulatory Knowledge: Strong understanding of ICH-GCP, Good Pharmacovigilance Practices (GVP), 21 CFR, and other international regulatory requirements. Technical Skills: Proficient in MS Office Suite (Outlook, Excel, Word, PowerPoint). Soft Skills: Excellent analytical, communication, and mentoring skills; ability to work independently and as part of a cross-functional team. Be part of a high-impact team contributing to global drug safety. Collaborate across a wide range of therapeutic areas and product portfolios. Develop and grow within a supportive, knowledge-driven work environment. Engage in continuous learning and professional development in a critical area of healthcare. Qualification : MBBS or MD is required

Technical Lead-Base Level (CTMS Setup) Location: Bengaluru (100% Home-based role) Job Overview: The Technical Lead will be responsible for developing, populating, and supporting templates related to clinical trial payments in the Clinical Trial Management System (CTMS) and other applicable payment systems. The role includes providing assistance and support to Contract & Centralized Services (CCS), business partners, and stakeholders in the use of CTMS for clinical trial payments. This is a fully remote position. Key Responsibilities: CTMS Payment Support: Support the study team training on CTMS payment processes and maintain data entry completeness for clinical trial payments. Issue Resolution & Tracking: Assist with complex issue resolution, resolve failed payments, track issue statuses, and attend meetings to review ongoing issues. Study Setup & Collaboration: Ensure proper study setup in CTMS, collaborate with business partners and stakeholders to address issues and ensure alignment with study goals. Template Creation & Revision: Create or revise payment templates in the CTMS and ensure their accuracy. Issue Management: Support issue resolution via the SAM tool, participate in team meetings, and provide support to other CCS CTMS regions. Adherence to Guidelines: Ensure that all services provided comply with client SOPs, WIs, policies, local regulatory requirements, and ICH-GCP guidelines. Additional Deliverables: Assist with any additional deliverables as assigned to meet project goals and ensure seamless study operations. Qualifications: Education: Bachelor's degree or equivalent in appropriate scientific or business disciplines. Experience: 2-4 years of experience in the pharmaceutical or clinical research industry, specifically in clinical trial payments, pricing, or budgeting. CTMS Experience: Strong hands-on experience with Clinical Trial Management Systems (CTMS) is a must; familiarity with EDC (Electronic Data Capture) systems is a plus. Communication Skills: Fluent in English, with excellent oral and written communication skills. Compliance Knowledge: Familiarity with healthcare compliance and other relevant regulations (e.g., HIPAA, FCPA, Safe Harbor, etc.). Analytical Skills: Strong analytical abilities and problem-solving skills to address challenges effectively. Cross-Functional Collaboration: Ability to work effectively in cross-functional teams and interact with various levels of the organization. PC & Database Management Skills: Proficiency with MS Office suite and database management tools. Work Style: Self-motivated with the ability to work independently and accomplish substantial tasks with minimal supervision. Virtual Work Experience: Previous experience working in a virtual environment and collaborating remotely. Desired Attributes: Innovative Spirit: Ability to bring forward creative solutions to complex problems. Interpersonal Skills: Strong ability to collaborate and maintain positive working relationships with team members and stakeholders. This position offers an exciting opportunity for an individual with a strong background in CTMS, clinical trial processes, and problem-solving abilities, seeking to work in a dynamic and fully remote environment. If you are a motivated professional with experience in clinical trial management and payments, we encourage you to apply. Qualification : Bachelor's degree or equivalent in appropriate scientific or business disciplines.

Lead/Associate Manager Case Processing 1 Location: Bengaluru Employment Type: Full-Time About the Role We are seeking a dynamic and experienced Lead/Associate Manager Case Processing to join our Pharmacovigilance team in Bengaluru. This role requires deep domain knowledge, leadership capability, and hands-on experience in handling Individual Case Safety Reports (ICSRs) across various sources. The ideal candidate will be responsible for managing day-to-day operations, ensuring compliance with global regulatory requirements, and mentoring a team of case processors. Key Responsibilities Operational Oversight Oversee and ensure the timely processing of ICSRs in accordance with SLA/KPI metrics. Allocate tasks effectively across the team to meet project deliverables and workload requirements. Proactively monitor team performance and work closely with team members to resolve operational or domain-related challenges. Risk & Issue Management Identify, escalate, and mitigate risks related to deliverables, compliance, or resourcing. Serve as a point of contact for internal stakeholders and clients regarding operational queries or escalations. Team Leadership & Performance Management Conduct regular performance evaluations, provide constructive feedback, and support career development of team members. Guide and mentor the team and Subject Matter Experts (SMEs) in ICSR processes, compliance standards, and MedDRA coding. Support functional capability development within the team and leadership pipeline. Training & Quality Assurance Conduct process and project-specific training as needed to ensure team competence and readiness. Ensure adherence to quality standards by contributing to quality system documentation, SOPs, and procedural updates. Provide feedback and suggestions to strengthen client/internal workflows and ensure continuous improvement. Process Improvement & Strategic Contribution Suggest and implement process enhancements to improve efficiency, accuracy, and compliance. Contribute to the development of scalable and sustainable pharmacovigilance processes. Collaborate cross-functionally to support strategic goals and business growth initiatives. Required Experience & Knowledge In-depth understanding of ICH-GCP, GVP modules, 21 CFR, and relevant global regulatory requirements. Proven expertise in managing high-volume ICSR workloads, including serious, non-serious, and potentially serious reports. Experience processing ICSRs from diverse sources: spontaneous, literature, solicited, regulatory authorities, and clinical trials. Exposure to therapeutic areas such as rare diseases and oncology is highly desirable. Experience in literature screening and review would be an added advantage. Proficient in MS Office applications (Excel, Word, Outlook, PowerPoint). Candidate Profile Education: Master s degree in Life Sciences, Pharmacy, or Medicine (or higher), aligned with project requirements. Experience: 10 12 years of relevant experience in pharmacovigilance, case processing, or related functions. Strong leadership skills with a proven ability to train, mentor, and manage cross-functional teams. Demonstrated ability to allocate resources, manage competing priorities, and maintain high-quality standards. Proactive, process-driven mindset with a commitment to continuous improvement and regulatory compliance. Work with a global leader in drug safety and pharmacovigilance services. Lead high-performing teams and contribute to the delivery of impactful healthcare solutions. Be part of a collaborative environment that values innovation, learning, and operational excellence. Apply now to lead meaningful work that impacts patient safety around the world. Qualification : Masters degree in Life Sciences, Pharmacy, or Medicine (or higher), aligned with project requirements

Job Purpose: The Director Process Management will be accountable for overseeing and optimizing assigned end-to-end business processes within Global Clinical Operations (GCO) to drive efficiency, compliance, standardization, and continuous improvement across the organization. They will lead and work collaboratively with cross-functional teams to identify areas for process improvement & innovation, implement best practices, control process health & compliance, and ensure processes align with GSK s strategic goals. Key Responsibilities: The responsibilities listed below outline the scope of the position. The application of these tasks may vary, based upon evolving business needs. As the Global Process Owner for assigned processes lead the design, maintenance, and continuous improvement of these end-to-end processes. Ensure these processes comply with regulatory requirements, are aligned with GCO s strategies, consider innovative approaches being developed in the industry, drive efficiency, and are well defined. Ensure that written standards are developed and maintained as needed to support the process and that written standards can be clearly understood by end-users. Provide necessary information and training to help users understand and implement these processes effectively. Define and implement process oversight strategy with key performance indicators, in-process controls, management monitoring and end-user feedback. Establish benchmarks and conduct periodic review of performance metrics to ensure effectiveness, efficiency, and compliance. Report process health and compliance to the relevant stakeholders proactively and take appropriate measures where deficiencies are identified. Influence and engage with the organization by building a strong network with stakeholders, partners, and subject matter experts to understand their drivers and needs along with broader organizational goals. Use these insights to craft alignment, drive meaningful change and improve end-user experience. Define and manage process change roadmaps, aligning priorities with system updates and innovations to address evolving business needs, manage risks or interdependencies, and implement improvements at scale. Lead strategy, planning, execution, and implementation of process change projects, ensuring improvements are achieved through a combination of process-people-system solutions. Partner with subject matter experts and support roles to deliver a comprehensive solution package that includes the end-to-end process itself, written standards, training, communication, change management, implementation, and monitoring plans. Maintain current knowledge of global regulations and guidance, global regulatory expectations, regulation intelligence and industry standards pertaining to the assigned processes. Proactively assess impact of any new regulations on assigned process and ensure ongoing compliance. Proactively educate themselves in evolutions and innovations across the industry and evaluate how they could positively benefit the effectiveness, efficiency or compliance of the process. Develop and align proposals with the appropriate stakeholders to drive process innovation that is aligned with GCO s strategic priorities and stakeholder needs. Maintain personal readiness to respond to internal audits and regulatory inspections, be the point of contact and interact with inspectors, and provide expert advice to respond to audit observations. Represent GSK in external forums to influence the external ecosystem in shaping industry-leading practices and development of innovative methodologies Basic Qualifications Bachelor s degree in Scientific discipline. Extensive experience in Pharmaceutical or Biotech industry working in Clinical Operations, Operational Excellence, or a related field. Excellent understanding of clinical operations processes, and ICH/GCP and global regulatory guidelines for drug development and approval processes with specific expertise in informed consent, clinical trial supplies and distribution of clinical safety documents. Experience leading major projects to completion and driving cross-functional improvements. Strong strategic and critical thinking, problem solving, influencing and decision-making capabilities. Forward-thinking and visionary mindset to modernize approach to clinical processes and leverage technology. Demonstrated matrix team leadership to deliver results. Demonstrated cross-functional collaborator with experience in building networks of partners and stakeholders, and broadly engaging with expert communities. Effective communication skills with ability to communicate and influence. Preferred Qualification Advanced degree in Scientific discipline Qualification : Bachelors degree in Scientific discipline.