Company Description Novaspire is a trusted partner to the pharmaceutical industry, dedicated to delivering comprehensive, high-quality clinical research services. We specialize in supporting pharmaceutical, biotechnology, medical device, and nutraceutical companies at every stage of the drug/product development lifecycle, from Phase I clinical studies to post-market surveillance. Our core services include pharmacovigilance, clinical trials, medical writing, bioequivalence study support, GxP consulting services & training, and imaging studies. With over 75 years of combined experience, our team of professionals has guided global healthcare companies through GxP compliance challenges by providing solutions and streamlining processes. Role Description This is a full-time on-site role for a Quality Assurance - Clinical Trials and PV professional located in the Greater Bengaluru Area. The Quality Assurance specialist will be responsible for implementing and maintaining quality management systems, conducting quality control and quality assurance activities, ensuring compliance with Good Manufacturing Practice (GMP) standards. Daily tasks will include quality auditing, supporting clinical trial activities, ensuring patient safety, and managing risk. The role involves working closely with multiple stakeholders to ensure the delivery of high-quality clinical research outcomes. Qualifications Experience in Quality Control and Quality Assurance Knowledge of Quality Management and Good Manufacturing Practice (GMP) standards Minimum 4 to 5 Years experience Skills in Quality Auditing and Compliance Strong organizational and communication skills Ability to work effectively on-site in a collaborative environment Bachelor’s degree in Life Sciences, Pharmacy, or a related field Experience in the pharmaceutical or biotechnology industry is a plus Show more Show less
Company Description Novaspire Biosciences Private Limited is a healthcare company specializing in Pharmacovigilance, Clinical Research, and Bioavailability/Bioequivalence studies Project Management support. Novaspire is dedicated to enhancing patient safety and promoting public health through innovative solutions for the pharmaceutical and biotechnology industries. Our team of experienced professionals provides a wide range of services, including Pharmacovigilance, Clinical Research Consulting, and Regulatory Affairs Solutions. Objectives of this role Ensuring compliance with protocols, standard operating procedures, and Good Clinical Practice (GCP) guidelines. Conducting regular site visits to monitor trial activities and data collection. Reviewing and analysing clinical trial data for accuracy and completeness. Developing and maintaining study timelines and budgets. Providing training to study staff on study protocols and GCP guidelines. Your tasks Reviewing and approving study-related documents, such as informed consent forms. Conducting source data verification and ensuring data quality. Managing trial supplies and drug accountability. Serving as a liaison between study sites, sponsors and regulatory agencies. Required skills and qualifications bachelor's/Master's degree in pharmacy. At least 1 year of experience in a similar role. Knowledge of regulatory requirements and guidelines, such as Good Clinical Practice (GCP) and International Council for Harmonization (ICH). Certification in clinical research, such as the Association of Clinical Research Professionals (ACRP) certification. Knowledge of clinical trial data management systems and electronic data capture. Experience with site selection, initiation, management, and monitoring activities. Strong attention to detail and accuracy in data management. Preferred skills and qualifications Understanding of pharmacology and drug development processes. Working knowledge of medical terminology and anatomy. Excellent project management and leadership skills with attention to detail. Ability to work collaboratively with study teams and cross-functional departments
Company Description At Novaspire Biosciences, we pride ourselves on being a trusted partner to the pharmaceutical industry, delivering comprehensive, high-quality clinical research services. We specialize in supporting pharmaceutical, biotechnology, medical device, and nutraceutical companies at every stage of the drug/product development lifecycle, from clinical studies Phase I to post-market surveillance. Our core services include pharmacovigilance, clinical trials, medical writing, bioequivalence study support, GxP consulting services & training, and imaging studies. With over 75 years of combined experience, our team provides solutions and streamlined processes to ensure efficient and effective research outcomes. Role Description • Organize, manage and maintain a highly compliant Pharmacovigilance (PV) system • Maintain awareness and ensure adherence to established and updated local and global processes and guidelines as well as national and international regulations and guidelines for pharmacovigilance. • Ensure PV business continuity and after hours availability. • Lead and coordinate internal and external PV audits and inspections. • Monitor PV system performance and compliance of partners and distributors. • Maintain expertise in country as well as worldwide regulations and guidelines and promote increased awareness of the legislative and regulatory environment in the country. • Accountable for all strategic PV activities • Active contribution to the activities relevant to the pharmacovigilance system to ensure monitoring of the safety profile • Act as the responsible contact person in the region, internally and externally, for safety-related aspects and PV. • Ensure internal regulatory/PV processes and procedures are well documented and support compliant regulatory/PV activities. • Perform other duties as assigned. Skills Required: • In depth knowledge of national/regional regulatory legislation and guidelines. • Knowledge of the pharmacovigilance regulations of all the countries. • Demonstrated ability to provide quality work using strong organizational, facilitation and interpersonal skills in a cross-functional team locally, within PV and externally. • Skilled at people management including overseeing and controlling outsourced vendor activities in a compliance/regulated field. • Capable of troubleshooting and managing multiple projects simultaneously. • Strong knowledge and understanding of medical terminology and clinical development processes • Rational approach to issues and their business implications, good problem solving and decision making skills. • Highly analytical with the ability to give attention to detail. • Excellent organizational skills and capable of working efficiently. • Possess an excellent interpersonal, verbal, and written communication skills. Minimum Requirements: • Minimum five years of working experience within the pharmaceutical industry and minimum five years within pharmacovigilance. • Degree / Advanced degree in medicine or in life sciences or equivalent experience • Excellent communication skills including proficiency in verbal and written English • Experience in other affiliate medical functions (e.g., Medical Affairs, Clinical Operations, Medical Information) or global clinical product development is considered advantageous. • Proficiency in Microsoft Word and Excel.
Company Description At Novaspire, we pride ourselves on being a trusted partner to the pharmaceutical industry, dedicated to delivering comprehensive, high-quality clinical research services. We specialize in supporting pharmaceutical, biotechnology, medical device, and nutraceutical companies at every stage of the drug/product development lifecycle, from clinical studies Phase I to post-market surveillance. Novaspire's core services include pharmacovigilance, clinical trials, medical writing, bioequivalence study support, GxP consulting services & training, and imaging studies. With over 75 years of combined experience, our team has guided companies through the complexities of GxP compliance by providing solutions and streamlining processes. Role Description · Plan and conduct site feasibilities, site selection visits, site initiation visits, monitoring visits, close out visits across Pan India Novaspire clinical sites/hospitals. · Prepare and send the confirmation and respective site visit reports as per the SOPs. · Send the visit follow-up letters and coordinate on action items with respective clinical site teams. · Coordinate for the site-set up activities. · Ensure the site and trial master files are updated. · Coordinate with clinical site teams for prompt data entries, source data verifications, data entry errors, corrections and closure of data issues. · Oversee end-to-end processing of ICSRs (spontaneous, literature, clinical trial, and solicited reports). · Contribute to narrative writing and seriousness assessment. · Analyse and handle product complaints and medical inquiries with cross-functional collaboration. · Conduct regular and ad hoc literature surveillance for safety signals and case identification. · Ensure audit readiness and adherence to company SOPs and regulatory expectations. · Coordinate with clinical sites, investigators, and internal teams to ensure timely execution of study activities. · Prepare and review essential trial documents, including informed consent forms, study protocols, and investigator brochures. Manage and maintain Trial Master File (TMF) and ensure documentation is complete and audit-ready. · Track study progress, monitor site performance, and manage data collection timelines. Prepare the SOPs related to PV/CT Department of Novaspire Biosciences as applicable. Qualifications Clinical trial monitoring, regulatory compliance, and documentation skills Experience with site visits and coordinating with clinical trial sites Strong attention to detail and data quality management skills Excellent communication and collaboration skills Experience in the pharmaceutical or biotechnology industry is a plus Bachelor's degree in Life Sciences, Pharmacy, Nursing, or related field Ability to work on-site in Bengaluru
Company Description At Novaspire Biosciences, we pride ourselves on being a trusted partner to the pharmaceutical industry, delivering comprehensive, high-quality clinical research services. We support pharmaceutical, Biotechnology, Medical Device, and Nutraceutical companies at every stage of the drug/product development lifecycle. Our core services include pharmacovigilance, expertly designed and executed clinical trials, accurate and high-quality medical writing, bioequivalence study support, and cutting-edge imaging studies. With over 75 years of combined experience, our GxP Consulting Services & Training team guides clients through GxP compliance challenges, ensuring clean data and industry readiness. Role Description · Write and edit clinical and regulatory documents such as: · Protocols and Amendments · Investigator Brochures, · Informed Consent Documents · Case Report Forms, · Clinical Study Reports (CSRs) · Common Technical Document (CTD) modules (e.g., 2.5, 2.7) – not mandatory · Develop scientific content for publications (manuscripts, abstracts, and posters), slide decks, and white papers. · Ensure documents comply with ICH-GCP, regulatory agency requirements (FDA, EMA, etc.), and internal company templates and SOPs. · Interpret clinical and scientific data accurately and present it clearly for various audiences. Provide strategic guidance on document planning and development when required. · Collaborate with cross-functional teams including clinical, regulatory, pharmacovigilance, and biostatistics teams. · Maintain version control and contribute to timelines and quality control throughout the document lifecycle. · Provide strategic guidance on document planning and development when required. · Any other client specific medical writing activities as assigned from time to time. · Prepare and review the medical writing SOPs when delegated. Train the team on medical writing related SOPs as required. Qualifications Scientific Writing and Medical Writing skills Proficiency in Medical Communications and general Writing Strong Research abilities Excellent written and verbal communication skills Ability to work independently and collaborate with diverse teams Experience in the pharmaceutical or healthcare industry is a plus Bachelor's or Master's degree in a related field such as Life Sciences, Medicine, Pharmacy, or equivalent
Company Description At Novaspire, we pride ourselves on being a trusted partner to the pharmaceutical industry, dedicated to delivering comprehensive, high-quality clinical research services. We support pharmaceutical, biotechnology, medical device, and nutraceutical companies at every stage of the product development lifecycle, from Phase I clinical studies to post-market surveillance. Our core services include pharmacovigilance, clinical trials, medical writing, bioequivalence study support, GxP consulting services and training, and imaging studies. We are committed to ensuring patient safety, regulatory compliance, and high-quality data to enhance clinical trial outcomes. Role Description Lead the operational planning and execution of Project Phase I-IV clinical trials across multiple therapeutic areas. Coordinate study start-up activities including site selection, feasibility, contract negotiations, and ethics/regulatory submissions. Manage CROs, vendors, and clinical sites to ensure timely delivery of study objectives. Develop and maintain project timelines, budgets, risk mitigation strategies, and status reports. Ensure that all trial documentation (protocols, CRFs, ICFs, etc.) meets regulatory and scientific standards. Monitor recruitment, data collection, protocol adherence, and query resolution across trial sites. Support internal and external audits and inspections. Oversee documentation and archiving processes including Trial Master File (TMF) maintenance. Participate in protocol development, clinical study report (CSR) preparation, and regulatory submissions. Review and approve CT-related SOPs and training materials. Train the CT team, assess, and retrain the team members of Novaspire as required. Qualifications Team Leadership and Training skills Minimum 6 years Experience in Clinical Operations and managing Clinical Trials Strong Research skills Excellent communication and organizational skills Ability to work effectively on-site in Bengaluru Bachelor's or Master's degree in a relevant field Experience in the pharmaceutical or biotechnology industry is a plus
As a Clinical Operations Manager at Novaspire, your role involves leading the operational planning and execution of Phase I-IV clinical trials across multiple therapeutic areas. You will be responsible for coordinating study start-up activities, managing CROs, vendors, and clinical sites, and ensuring timely delivery of study objectives. Your key responsibilities include: - Coordinating study start-up activities such as site selection, feasibility, contract negotiations, and ethics/regulatory submissions. - Developing and maintaining project timelines, budgets, risk mitigation strategies, and status reports. - Monitoring recruitment, data collection, protocol adherence, and query resolution across trial sites. - Supporting internal and external audits and inspections. - Overseeing documentation and archiving processes including Trial Master File (TMF) maintenance. - Participating in protocol development, clinical study report (CSR) preparation, and regulatory submissions. - Reviewing and approving CT-related SOPs and training materials. - Training the CT team, assessing, and retraining team members as required. Your qualifications for this role include: - Team Leadership and Training skills - Minimum 6 years Experience in Clinical Operations and managing Clinical Trials - Strong Research skills - Excellent communication and organizational skills - Ability to work effectively on-site in Bengaluru - Bachelor's or Master's degree in a relevant field - Experience in the pharmaceutical or biotechnology industry is a plus At Novaspire, we are committed to ensuring patient safety, regulatory compliance, and high-quality data to enhance clinical trial outcomes. Join us in our mission to deliver comprehensive, high-quality clinical research services to the pharmaceutical industry.,
Company Description Novaspire Biosciences is a reliable partner to the pharmaceutical industry, offering high-quality clinical research services. Serving pharmaceutical, biotechnology, medical device, and nutraceutical companies, Novaspire supports the complete drug development lifecycle—from Phase I clinical trials to post-market surveillance. The company provides specialized services including pharmacovigilance, clinical trials, medical writing, bioequivalence study support, GxP consulting and training, and imaging studies. With an experienced team, Novaspire ensures detailed compliance, streamlined processes, and clean data while also training clinical research aspirants to be industry-ready. Role Description This is a full-time, on-site HR & Admin Executive role based in Bengaluru. The HR & Admin Executive will manage HR operations including employee relations, implementation of HR policies, and operational HR tasks. Responsibilities include coordinating recruitment processes, maintaining employee records, and supporting administrative functions. The role also involves fostering a positive work environment and ensuring compliance with organizational policies. Qualifications Proficiency in HR Management, HR Operations, and implementing HR Policies Experience in Employee Relations and a strong understanding of Human Resources (HR) practices Organizational skills with attention to detail and the ability to multitask Effective communication and interpersonal skills Bachelor’s degree in Human Resources, Business Administration, or a related field Knowledge of labor laws and compliance regulations is a plus Previous experience in an on-site HR role is preferred
Company Description Novaspire Biosciences is a reliable partner to the pharmaceutical industry, offering high-quality clinical research services. Serving pharmaceutical, biotechnology, medical device, and nutraceutical companies, Novaspire supports the complete drug development lifecyclefrom Phase I clinical trials to post-market surveillance. The company provides specialized services including pharmacovigilance, clinical trials, medical writing, bioequivalence study support, GxP consulting and training, and imaging studies. With an experienced team, Novaspire ensures detailed compliance, streamlined processes, and clean data while also training clinical research aspirants to be industry-ready. Role Description This is a full-time, on-site HR & Admin Executive role based in Bengaluru. The HR & Admin Executive will manage HR operations including employee relations, implementation of HR policies, and operational HR tasks. Responsibilities include coordinating recruitment processes, maintaining employee records, and supporting administrative functions. The role also involves fostering a positive work environment and ensuring compliance with organizational policies. Qualifications Proficiency in HR Management, HR Operations, and implementing HR Policies Experience in Employee Relations and a strong understanding of Human Resources (HR) practices Organizational skills with attention to detail and the ability to multitask Effective communication and interpersonal skills Bachelor's degree in Human Resources, Business Administration, or a related field Knowledge of labor laws and compliance regulations is a plus Previous experience in an on-site HR role is preferred
Company Description At Novaspire Biosciences, we pride ourselves on being a trusted partner to the pharmaceutical industry, delivering comprehensive, high-quality clinical research services. We specialize in supporting pharmaceutical, biotechnology, medical device, and nutraceutical companies at every stage of the drug/product development lifecycle, from clinical studies Phase I to post-market surveillance. Our core services include pharmacovigilance, clinical trials, medical writing, bioequivalence study support, GxP consulting services & training, and imaging studies. With over 75 years of combined experience, our team provides solutions and streamlined processes to ensure efficient and effective research outcomes. Key Responsibility: • Responsible for providing advice and support to the project team for regulatory operations aspects of the projects. • Manage and ensure maintenance of a positive and productive liaison with internal and external contacts (i.e. regulatory agencies, clients, co-workers, staff, etc.) • Maintain a strong customer service management approach with clients. • Lead project teams and advise departments on regulatory standards issues and strategies • Develop, write, and implement standards and procedures related to regulatory operations. • Identify client issues and develop alternative strategies for presentation to client consulting with other resources within organization as required • Participate actively in other business related projects (business opportunities, client specific issues, etc.) and planning. • Client consultation and preparation of quotes and is responsible for achieving utilization goals of the EU unit. • Completing other appropriate duties as assigned by line manager that require similar skills Skills Required: Preparation and submission of Clinical Trial application dossier on the Regulatory portal. Experience in preparation of Dossier for South African Regulatory, FDA and EMA Submission of the dossiers and regular follow up with Regulatory officials till approval. Preparation and submission of a dossier for Post Approval changes including Major Protocol Amendment, Minor Protocol Amendment, IB/ICF/CRF notifications, Site Addition, Site closure and PI Changes etc. Handled CTRI site and SUGAM portal. Experience in eCTD, NeeS, Paper Submissions. Experience in EU, US, South Africa, GCC and Canada HA submissions. Experience in Lorenz Docubridge and ISI Tool Box Experience in sequence building and document level publishing Good knowledge on the CTD sections. Minimum Requirements: • Minimum 4 to 5 years of working experience working with different countries regulatory officials. • Excellent communication skills including proficiency in verbal and written English • Proficiency in Microsoft Word and Excel.
Company Description Novaspire Biosciences is a trusted partner to the pharmaceutical, biotechnology, medical device, and nutraceutical industries, providing comprehensive and high-quality clinical research services. Our expertise spans the entire drug and product development lifecycle, from Phase I clinical studies to post-market surveillance. Core services include pharmacovigilance, clinical trial management, medical writing, bioequivalence study support, GxP consulting, and imaging studies. With over 75 years of combined experience, our team excels in ensuring compliance, optimizing processes, and delivering clean data to accelerate time-to-market. Novaspire is dedicated to improving patient safety and enhancing clinical trial outcomes with innovative and reliable solutions. Role Description This is a full-time on-site role located in Bengaluru for a Pharmacovigilance Team Lead/Manager with 5 years of experience. The role involves overseeing all pharmacovigilance operations, ensuring compliance with regulatory requirements, and managing adverse event reporting. Responsibilities include leading a team of pharmacovigilance professionals, developing and implementing risk management plans, coordinating with cross-functional teams, and contributing to regulatory submissions. The Team Lead/Manager will play a critical role in fostering a culture of patient safety and ensuring adherence to high-quality standards in all related processes. Qualifications Strong understanding of Regulatory Requirements and experience in Regulatory Affairs In-depth knowledge of pharmacy and medicine principles relevant to pharmacovigilance and drug safety Experience with Clinical Trials, including post-market surveillance and risk management Demonstrated leadership, team management, and excellent communication skills Proficiency with pharmacovigilance databases and tools Master’s or postgraduate degree in Pharmacy, Medicine, Life Sciences, or a related field Knowledge of local and international regulatory guidelines, such as ICH-GCP, is highly desirable Attention to detail, problem-solving mindset, and the ability to work effectively under timelines