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.