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100.0 years

0 Lacs

Indore, Madhya Pradesh, India

On-site

Locations – Indore & Lucknow Department – New Generation Insulin (NGI) Novo Nordisk India Private Limited Are you an experienced medical professional and passionate about Medical Affairs? Does being part of a growing, yet dynamic environment excite you? Are you adept in implementing the medical affairs strategy in the country? Apply now with your latest profile and you may be our new Regional Medical Advisor. The Position As a Regional Medical Advisor, you will contribute actively to medico-marketing activities in the business area/portfolio and support in implementation of the Medical Affairs strategy in the country. You will be responsible for: Executing the Indian medical strategy into local activities in your designated region Building, maintaining, and nurturing the excellent scientific relationship with all the key influencers and stakeholders Training and educational activities for Physicians and other Health Care Professionals (HCPs) working with diabetes and obesity Medical support to brand team You will also be responsible for: To assist the marketing and sales team in sharpening and positioning product and promotional strategies. Foresee the challenges as well as changing market dynamics and make timely corrective and preventive actions. You will stay updated on scientific knowledge by actively participating in scientific meetings, gathering clinical insights/needs/feedback from key opinion leaders, and communicating with internal stakeholders. Responsible for educating and training the field and marketing personnel and other relevant stakeholders regarding all aspects of disease, product, and therapy relevant to promotional strategy. You will build a strong advocacy of Novo Nordisk’s portfolio with key external stakeholders through ongoing/robust scientific interactions. Qualifications MBBS/ MD in Pharmacology from a reputed institution. You shall have strong scientific knowledge and interest in diabetes and obesity including both the therapy area and the products, good collaboration with internal and external stakeholders as well as good communication and negotiation. Strong analytical capabilities, with demonstrated experience in analyzing complex situations. Skills for planning, execution, and follow-up are required, with a creative and innovative attitude that will enable you to drive initiatives with operational excellence and strive towards working with both operational as well as more judicious tasks. About The Department The Clinical, Medical, and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From HCP interactions and developing and implementing regulatory strategies with the health authorities to providing medical education and collecting data to support our products, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for living. Working at Novo Nordisk Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with an unconventional spirit, a rare determination and a constant curiosity. For over 100 years this unordinary mindset has seen us build a company unlike any other. One where a collective passion for our purpose, mutual respect and a willingness to go beyond what we know delivers extraordinary results. Contact To submit your application, please upload your CV and motivational letter online (click on Apply and follow the instructions). Internal candidates are kindly requested to inform their line Managers before applying. Deadline 24/07/2025 Disclaimer It has been brought to our attention that there have recently been instances of fraudulent job offers, purporting to be from Novo Nordisk and/or its affiliate companies. The individuals or organizations sending these false employment offers may pose as a Novo Nordisk recruiter or representative and request personal information, purchasing of equipment or funds to further the recruitment process or offer paid trainings. Be advised that Novo Nordisk does not extend unsolicited employment offers. Furthermore, Novo Nordisk does not charge prospective employees with fees or make requests for funding as a part of the recruitment process. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

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3.0 - 4.0 years

0 Lacs

Bengaluru, Karnataka, India

On-site

Mandate - Pharma The purpose of the Consultant/ Senior Associate Consultant ; Economic Modelling role is to work with cross-functional, multidisciplinary teams to develop Health Technology Assessment (HTA) related documents (including but not limited to cost effectiveness analysis model, cost minimization analysis model, cost-responder analysis model, early phase modelling) and/or facilitate external scientific publications (including but not limited to, abstracts, posters, manuscripts and presentations) Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position. Document Preparation / Document Management (75%): Plan, write, edit, review and coordinate the adaptation of Economic Model and HTA documents Conduct quality checks to ensure the accuracy of data included in economic model. Collate reviewer’s comments, revise the economic model as required based on internal/external input, and prepare final version of the model along with the report. Exhibit flexibility in moving across development and preparation of multiple document types. Work with teams to ensure smooth and timely development of economic model and the report. Influence or negotiate change of timelines and content with other team members. Effectively collect and evaluate information from multiple sources. Participate in the Global Economic Model Development Knowledge and Skills Development (15%): Maintain and enhance economic modelling knowledge including, programming skills, alternative platforms and related software Maintain basic knowledge of Health Outcomes related research including RWE studies, understanding of economic evaluation; Patient Reported Outcome studies etc. Possess overarching view of compound, therapeutic area, and external environment (including competitors) with the ability to modify the economic model as per the country requirement. Knowledge Sharing and Consultant Support (5%): Provide informal coaching to others by sharing technical information, giving guidance, answering questions. Recognized for technical expertise in specific economic model & document development. Network with others to identify and share best practices globally. Contribute to process improvements, suggesting opportunities where appropriate. Customer Focus (5%): Work with internal and external stakeholders to adapt the economic model as per their requirement. Engage in activities supporting reward and recognition, teambuilding, and diversity. Support cross-functional coaching, mentoring, and training. Minimum Qualification Requirements: Bachelor’s Degree with at least 3-4 years' experience in drug development and/or knowledge in health outcomes research. Experience in medical, scientific or technical writing fields (at least 2 years) Have relevant experience in developing economic model Cognitive abilities including; verbal reasoning, attention to detail, critical thinking, and analytical ability. Demonstrated project management and time management skills. Strong comprehension and communication skills including the ability to translate and disseminate complex scientific information in a clear and concise manner Excellent written and verbal communication skills Demonstrated ability to influence and collaborate within and across teams Strong interpersonal skills and the ability to be flexible in varying environments and with multiple customer groups. Demonstrated high-level end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentation and templates). Demonstrated programming skills in software typically used for health economic modeling, especially in MS Excel with Visual Basics. Other Information/Additional Preferences: Project Management experience would be an advantage Epidemiology, clinical pharmacology, therapeutic area, or other medical and scientific specific knowledge and experience (e.g., immunology, diabetes, or oncology expertise). Expertise with understanding the pros and cons of different approaches to generate Real World Evidence. Publication experience Ability to work well independently and as part of a team.

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5.0 - 9.0 years

0 Lacs

Hyderabad, Telangana, India

On-site

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Business Systems Analyst - Law and Compliance Technology What You Will Do Let’s do this. Let’s change the world. The role demonstrates domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the software development teams. This role involves working closely with developers, business analysts and SaaS suppliers to ensure that the technical requirements for upcoming development are thoroughly elaborated. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will collaborate with Product Managers, developers and SaaS supplier teams to maintain an efficient and consistent process, ensuring quality work from the team. Roles & Responsibilities: Collaborate with System Architects, Product Managers and Suppliers to manage business analysis activities, ensuring alignment with engineering and product goals Capture the voice of the customer to define business processes and product needs Work with Product Managers and customers to define scope and value for new capabilities Ensure non-functional requirements are included and prioritized in the Product and Release Backlogs Facilitate the breakdown of Epics into Features and Sprint-Sized User Stories and participate in backlog reviews with the development team Clearly express features in User Stories/requirements so all team members and stakeholders understand how they fit into the product backlog Ensure Acceptance Criteria and Definition of Done are well-defined Stay focused on delivery to ensure product meets requirements, providing proactive feedback to stakeholders Develop and implement effective product demonstrations for internal and external stakeholders Maintain accurate documentation of configurations, processes, and changes Develop detailed test plans and strategies based on project requirements and specifications Perform manual and automated testing of software applications, including functional, regression, and performance testing Document and report defects and issues identified during testing, and work with development teams to resolve them Maintain detailed documentation of test plans, test cases, and test results Validate that test scenarios meet feature acceptance criteria and customer expectations Maintain and ensure the quality of documented user stories/requirements in tools such as Jira Serve as a liaison between global Technology and Artificial Intelligence and Data Teams and business stakeholders, prioritizing their needs and expectations Manage a suite of custom internal platforms, commercial off-the-shelf (COTS) software, Software-as-a-Service (SaaS) and systems integrations Identify and manage risks associated with the systems, including technological risks, system validation and user acceptance Leads coordination and tracking of system incidents, integration failures, and performance issues. Performs root cause analysis (RCA) in collaboration with business users and vendors to identify, document, and call out issues. Creates, manages, and follows up on tickets via vendor support portals for SaaS applications. Ensures high-priority incidents are addressed swiftly, with communication to business stakeholders and traceable resolution paths. Understands the impact of system incidents on legal workflows and data integrity, and acts promptly to mitigate business disruption. What We Expect Of You We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master's degree / Bachelor's degree and 5 to 9 years of Life Science/Biotechnology/Pharmacology/Information Systems experience Must-Have Skills Excellent problem-solving skills and a passion for tackling complex challenges with technology Experience with Agile software development methodologies (Scrum) Good communication skills and the ability to collaborate with leadership with confidence and clarity Experience in writing requirements for development of modern web application Has experience with writing user requirements and acceptance criteria in agile project management systems such as JIRA Strong knowledge SharePoint including ability to produce and manage sites, document libraries, user access, SharePoint forms, and basic workflows. Preferred Qualifications: Good-to-Have Skills: Demonstrated expertise in Legal and / or Compliance technology Understanding of software systems strategy, governance, and infrastructure Experience in managing product features for PI planning and developing product roadmaps and user journeys Familiarity with low-code, no-code test automation software Able to communicate technical or complex subject matters in business terms Jira Align experience Experience using Lucidchart / Visio for creating process flows, traceability maps, and system diagrams. Experience with Microsoft Power Platform: Power BI, Power Automate, Power Apps. Experience with Tableau or equivalent data visualization tools. Experience with OpenAI tools for data mapping and structured content generation. Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams. High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills What You Can Expect Of Us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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1.0 - 6.0 years

0 - 0 Lacs

nellore, prakasam, baloda bazar

On-site

A pharmacist is a healthcare professional who dispenses prescription medications, provides information about drugs, and advises on their use . They ensure safe medication practices by reviewing prescriptions, monitoring patient histories, and staying updated on drug information. Pharmacists also collaborate with other healthcare professionals to optimize patient treatment plans and manage pharmacy inventory. Key responsibilities of a pharmacist include: Dispensing medications: Preparing and labeling medications according to prescriptions, ensuring accuracy and proper dosage. Providing drug information: Educating patients and other healthcare professionals about medications, including their effects, side effects, and interactions. Reviewing prescriptions: Ensuring prescriptions are accurate, appropriate, and legal before dispensing medications. Monitoring patient health: Tracking patient medication history, identifying potential drug interactions, and recommending appropriate interventions. Managing pharmacy operations: Organizing the pharmacy, maintaining inventory, and ensuring compliance with regulations. Collaborating with healthcare professionals: Working with physicians, nurses, and other healthcare providers to optimize patient care. Providing health advice: Offering guidance on medication use, disease prevention, and overall health and wellness. Keeping records: Maintaining accurate records of prescriptions, patient information, and inventory. Staying updated: Continuously learning about new medications, treatment protocols, and regulations

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1.0 - 6.0 years

3 - 5 Lacs

Bengaluru

Work from Office

Job Description Designation: Pharmacist Role: QC Pharmacist Department: Warehouse Operations Location: Bangalore/Chennai / Mumbai About Tata 1mg Tata 1mg is a trusted health partner for end consumers and large institutions. Our Mission is to make healthcare understandable, accessible, and affordable for all Indians. Over the past three years, we've worked to build a healthcare platform that guides customers to the right and affordable care. Today, Tata 1mg is present in 1000+ cities And were just getting started. Leading the chart as one of the top consumer health platforms through ePharmacy, eDiagnostics, e-consult and offline stores, Tata 1mg has delivered over 15M ePharmacy orders, 2M eDiagnostics orders & 1M+ organic users/day in 2022 and we are just getting started. Our strongest asset is our 6400+ people enabling us to deliver on our mission consistently. Know more about us: https://www.1mg.com/aboutUs Brief about the Team The warehouse operations team is within the supply chain vertical of Tata 1mg. The team works closely with the org-wide leadership team, business, product, growth, and category teams to drive operational excellence and strategic initiatives. The team works on special projects and innovations that aim to deliver high impact. The projects span across business verticals including e-pharma, e- diagnostics, and retail. What will you do What will you do Customer Support Read & validate prescriptions (Rx) + OTC orders Contact customers for clarification or information required to process the order - Situational requirements Inventory Management & Order Processing management Responsible for physically performing order picking, quality checks, packing and handover to the riders Ensure all orders are processed within the defined cut-off TAT (Turnaround Time) Responsible for physically performing stock receiving and put away processes Conduct daily stock audits and ensure accountability for inventory shrinkage Follow up and ensure timely closure of pullout and purchase returns Ensure customer satisfaction through timely order fulfillment, issue resolution, and excellent service Compliance Ensure strong quality checks while packing/ dispensing medicines Ensure 100% compliance per the process guidelines What we are looking for 1 + years of relevant experience (pharmacist Diploma or Bachelor (D. Pharma or B. Pharma License for that state. Should be comfortable working in shifts and on weekends Why Join Us? Tata 1mg provides one of the most exciting and high-growth environments to work. You get the added benefit of working in a prestigious legacy brand like Tata and a highly dynamic and versatile startup like 1mg. Being an integral part of the Warehouse Operations will provide you to closely work with the Operations and Logistics team which is spread PAN India.

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0.0 - 1.0 years

12 - 15 Lacs

Bhuj

Work from Office

Senior Residents assist in teaching undergraduate/postgraduate students through demonstrations, case presentations, Teaching and supervision of interns and junior residents. Participate in seminars, journal clubs, and academic discussions.

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0.0 - 3.0 years

1 - 2 Lacs

Udaipur

Work from Office

Job description "JOIN US TO SHAPE THE FUTURE OF HEALTHCARE" GEETANJALI MEDICAL COLLAGE AND HOSPITAL Position - Senior Resident l Assistant Professor Department - Pharmacology Contact : 7023104974 Email : carrer@geetanjaliuniversity.com Location : Geetanjali Medical Collage & Hospital, Udaipur, Rajasthan Education: MD / Msc. Phd.

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4.0 years

0 Lacs

New Delhi, Delhi, India

On-site

About Us We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence. As a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations. About SCPA We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers. About The Role As part of our continued growth, we are looking to recruit technical and experienced In-Vitro Diagnostic Medical Device Assessors and Lead Auditors. The successful candidates will be responsible for planning and conducting audits / assessments against the manufacturing of medical devices, in accordance with ISO 13485, IVDR 2017/746 and MDSAP standards, enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards. Key Accountabilities: Assessor Conduct assessments (either desk-based or on client’s sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer communication. Conduct Technical File reviews specific for products being authorized. Complete all chargeable work within the required timeframes to ensure customer satisfaction and efficiency of the business. Complete specific projects in relation to IVDR procedures, processes, systems and documentation as requested by the Operations Manager. If required, undertake reviews of files and make certification decisions within target timescales and in line with DNV policies and accreditation/approval requirements. Key Accountabilities: Auditor Responsible to carry out audits of the manufacturer's quality management system (QMS) and of its suppliers and/or subcontractors when appropriate and to draw up records and reports on the corresponding audits. Conduct surveillance audits including follow-up activities in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships. Complete all chargeable work within the required timeframes to ensure customer satisfaction and efficiency of the business. Complete projects in relation to IVDR procedures, processes, systems and documentation as requested by the Operations Manager. If required, undertake reviews of files and make certification recommendations within target timescales and in line with DNV policies and accreditation/approval requirements. Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards. What we offer Flexible work arrangements for better work-life balance Generous Paid Leaves (Annual, Sick, Compassionate, Local Public, Marriage, Maternity, Paternity, Medical leave) Medical benefits ( Insurance and Annual Health Check-up) Pension and Insurance Policies (Group Term Life Insurance, Group Personal Accident Insurance, Travel Insurance) Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme) Additional Benefits (Long Service Awards, Mobile Phone Reimbursement) Company bonus/Profit share. *Benefits may vary based on position, tenure/contract/grade level* DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity. About You Assessors and Auditors shall have a technical college degree in a relevant product or medical area, as described below. In-Vitro Diagnostic devices: Biology or Microbiology Chemistry or Biochemistry Human Physiology Medical Technology or Biotechnology Medicine, Veterinary Medicine Biomedical science - e.g. haematology, virology, molecular diagnostics Nursing Pharmacy, Pharmacology, Toxicology Physiology Education In addition to a relevant educational degree, candidates must have a minimum 4 years’ work experience (full time) in an In-Vitro diagnostic medical device related industry, academia or hospital environment, with at least 2 of these years in the design, manufacturing, testing or use of the device in which they are qualified to Audit or Assessment, and/or experience as an assessor or auditor in a notified body. Specifically: Auditor - Practical experience in the quality management system and specific production process/technologies for the IVD medical devices. Assessor - Practical experience in conducting and/or assessing performance evaluation data or related scientific aspects with in-vitro diagnostic medical devices in one or more of the following areas Microbiology, Immunology, Genetic testing/Cancer Biology and Molecular Biology. A PhD in a relevant area for in-vitro diagnostic medical devices can substitute 3 years of work experience provided it includes 2 years’ experience in design, manufacture or testing. In addition to the above, knowledge of the following would be preferred: An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques. Work experience in positions with significant QA Regulatory or management systems responsibility. Experience with Harmonized medical device standards for In-Vitro diagnostic medical devices. Experience with Risk Management EN ISO 14971. Medical device experience from auditing/work. Experience auditing against recognized standards. Experience of working under own initiative and in planning and prioritizing workloads. Should have a flair for technical writing, essential for exhaustive report writing.

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4.0 years

0 Lacs

Chennai, Tamil Nadu, India

On-site

About Us We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence. As a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations. About SCPA We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers. About The Role As part of our continued growth, we are looking to recruit technical and experienced In-Vitro Diagnostic Medical Device Assessors and Lead Auditors. The successful candidates will be responsible for planning and conducting audits / assessments against the manufacturing of medical devices, in accordance with ISO 13485, IVDR 2017/746 and MDSAP standards, enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards. Key Accountabilities: Assessor Conduct assessments (either desk-based or on client’s sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer communication. Conduct Technical File reviews specific for products being authorized. Complete all chargeable work within the required timeframes to ensure customer satisfaction and efficiency of the business. Complete specific projects in relation to IVDR procedures, processes, systems and documentation as requested by the Operations Manager. If required, undertake reviews of files and make certification decisions within target timescales and in line with DNV policies and accreditation/approval requirements. Key Accountabilities: Auditor Responsible to carry out audits of the manufacturer's quality management system (QMS) and of its suppliers and/or subcontractors when appropriate and to draw up records and reports on the corresponding audits. Conduct surveillance audits including follow-up activities in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships. Complete all chargeable work within the required timeframes to ensure customer satisfaction and efficiency of the business. Complete projects in relation to IVDR procedures, processes, systems and documentation as requested by the Operations Manager. If required, undertake reviews of files and make certification recommendations within target timescales and in line with DNV policies and accreditation/approval requirements. Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards. What we offer Flexible work arrangements for better work-life balance Generous Paid Leaves (Annual, Sick, Compassionate, Local Public, Marriage, Maternity, Paternity, Medical leave) Medical benefits ( Insurance and Annual Health Check-up) Pension and Insurance Policies (Group Term Life Insurance, Group Personal Accident Insurance, Travel Insurance) Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme) Additional Benefits (Long Service Awards, Mobile Phone Reimbursement) Company bonus/Profit share. *Benefits may vary based on position, tenure/contract/grade level* DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity. About You Assessors and Auditors shall have a technical college degree in a relevant product or medical area, as described below. In-Vitro Diagnostic devices: Biology or Microbiology Chemistry or Biochemistry Human Physiology Medical Technology or Biotechnology Medicine, Veterinary Medicine Biomedical science - e.g. haematology, virology, molecular diagnostics Nursing Pharmacy, Pharmacology, Toxicology Physiology Education In addition to a relevant educational degree, candidates must have a minimum 4 years’ work experience (full time) in an In-Vitro diagnostic medical device related industry, academia or hospital environment, with at least 2 of these years in the design, manufacturing, testing or use of the device in which they are qualified to Audit or Assessment, and/or experience as an assessor or auditor in a notified body. Specifically: Auditor - Practical experience in the quality management system and specific production process/technologies for the IVD medical devices. Assessor - Practical experience in conducting and/or assessing performance evaluation data or related scientific aspects with in-vitro diagnostic medical devices in one or more of the following areas Microbiology, Immunology, Genetic testing/Cancer Biology and Molecular Biology. A PhD in a relevant area for in-vitro diagnostic medical devices can substitute 3 years of work experience provided it includes 2 years’ experience in design, manufacture or testing. In addition to the above, knowledge of the following would be preferred: An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques. Work experience in positions with significant QA Regulatory or management systems responsibility. Experience with Harmonized medical device standards for In-Vitro diagnostic medical devices. Experience with Risk Management EN ISO 14971. Medical device experience from auditing/work. Experience auditing against recognized standards. Experience of working under own initiative and in planning and prioritizing workloads. Should have a flair for technical writing, essential for exhaustive report writing.

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4.0 years

0 Lacs

New Delhi, Delhi, India

On-site

About Us We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence. As a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations. About SCPA We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers. About The Role DNV Product Assurance AS is one of the leading Notified Bodies for IVD medical devices. The unit is entitled to carry out tasks related to conformity assessment of IVD medical devices with Regulation (EU) 2017/746 In Vitro Medical Devices before such products are placed on the market. The role of Clinical Assessor is to assess performance data supporting safety and performance of IVD medical devices. Main Tasks In This Role Are Performing assessment and preparing reports of clinical performance aspects of legal manufacturers' technical documentation according to the requirements given in the Regulation (EU) 2017/746. Evaluation of the summary of safety and performance reports for high-risk IVD medical devices. Review and approval of performance evaluation report and other relevant performance documentation for accuracy and compliance with the requirements in the Regulation (EU) 2017/746. Education And Competencies Required Clinical Assessors shall have a technical college degree in a relevant product or medical area, as described below. Biology or Microbiology Chemistry or Biochemistry Human Physiology Medical Technology or Biotechnology Medicine, Veterinary Medicine Biomedical science - e.g. haematology, virology, molecular diagnostics Nursing Pharmacy, Pharmacology, Toxicology Physiology What we offer A competitive compensation and benefit package DNV training and qualification program A professional community in a prestigious technological company Possibilities to work with interesting and challenging projects Access to an extensive competence network Flexible work arrangements for better work-life balance Generous Paid Leaves (Annual, Sick, Compassionate, Local Public, Marriage, Maternity, Paternity, Medical leave) Medical benefits ( Insurance and Annual Health Check-up) Pension and Insurance Policies (Group Term Life Insurance, Group Personal Accident Insurance, Travel Insurance) Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme) Additional Benefits (Long Service Awards, Mobile Phone Reimbursement) Company bonus/Profit share.DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity. About You Candidates must have a minimum 4 years’ work experience (full time) in an In-Vitro diagnostic medical device related industry, academia or hospital environment, with at least 2 of these years in the Assessment of Performance evaluation data, including Scientific Validity and Clinical Performance, or conducting performance evaluation studies for IVD devices. A PhD in a relevant area for IVD medical devices can substitute 3 years of work experience provided that it includes 2 years’ experience in Performance evaluation. Personal Qualities Analytical approach. Strong communication skills. Customer focus. Excellent reporting skills. Ability to work independently and efficiently. Ability to form recommendations on certification in complex cases.

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4.0 years

0 Lacs

Chennai, Tamil Nadu, India

On-site

About Us We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence. As a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations. About SCPA We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers. About The Role DNV Product Assurance AS is one of the leading Notified Bodies for IVD medical devices. The unit is entitled to carry out tasks related to conformity assessment of IVD medical devices with Regulation (EU) 2017/746 In Vitro Medical Devices before such products are placed on the market. The role of Clinical Assessor is to assess performance data supporting safety and performance of IVD medical devices. Main Tasks In This Role Are Performing assessment and preparing reports of clinical performance aspects of legal manufacturers' technical documentation according to the requirements given in the Regulation (EU) 2017/746. Evaluation of the summary of safety and performance reports for high-risk IVD medical devices. Review and approval of performance evaluation report and other relevant performance documentation for accuracy and compliance with the requirements in the Regulation (EU) 2017/746. Education And Competencies Required Clinical Assessors shall have a technical college degree in a relevant product or medical area, as described below. Biology or Microbiology Chemistry or Biochemistry Human Physiology Medical Technology or Biotechnology Medicine, Veterinary Medicine Biomedical science - e.g. haematology, virology, molecular diagnostics Nursing Pharmacy, Pharmacology, Toxicology Physiology What we offer A competitive compensation and benefit package DNV training and qualification program A professional community in a prestigious technological company Possibilities to work with interesting and challenging projects Access to an extensive competence network Flexible work arrangements for better work-life balance Generous Paid Leaves (Annual, Sick, Compassionate, Local Public, Marriage, Maternity, Paternity, Medical leave) Medical benefits ( Insurance and Annual Health Check-up) Pension and Insurance Policies (Group Term Life Insurance, Group Personal Accident Insurance, Travel Insurance) Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme) Additional Benefits (Long Service Awards, Mobile Phone Reimbursement) Company bonus/Profit share.DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity. About You Candidates must have a minimum 4 years’ work experience (full time) in an In-Vitro diagnostic medical device related industry, academia or hospital environment, with at least 2 of these years in the Assessment of Performance evaluation data, including Scientific Validity and Clinical Performance, or conducting performance evaluation studies for IVD devices. A PhD in a relevant area for IVD medical devices can substitute 3 years of work experience provided that it includes 2 years’ experience in Performance evaluation. Personal Qualities Analytical approach. Strong communication skills. Customer focus. Excellent reporting skills. Ability to work independently and efficiently. Ability to form recommendations on certification in complex cases.

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4.0 years

0 Lacs

Greater Kolkata Area

On-site

About Us We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence. As a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations. About SCPA We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers. About The Role DNV Product Assurance AS is one of the leading Notified Bodies for IVD medical devices. The unit is entitled to carry out tasks related to conformity assessment of IVD medical devices with Regulation (EU) 2017/746 In Vitro Medical Devices before such products are placed on the market. The role of Clinical Assessor is to assess performance data supporting safety and performance of IVD medical devices. Main Tasks In This Role Are Performing assessment and preparing reports of clinical performance aspects of legal manufacturers' technical documentation according to the requirements given in the Regulation (EU) 2017/746. Evaluation of the summary of safety and performance reports for high-risk IVD medical devices. Review and approval of performance evaluation report and other relevant performance documentation for accuracy and compliance with the requirements in the Regulation (EU) 2017/746. Education And Competencies Required Clinical Assessors shall have a technical college degree in a relevant product or medical area, as described below. Biology or Microbiology Chemistry or Biochemistry Human Physiology Medical Technology or Biotechnology Medicine, Veterinary Medicine Biomedical science - e.g. haematology, virology, molecular diagnostics Nursing Pharmacy, Pharmacology, Toxicology Physiology What we offer A competitive compensation and benefit package DNV training and qualification program A professional community in a prestigious technological company Possibilities to work with interesting and challenging projects Access to an extensive competence network Flexible work arrangements for better work-life balance Generous Paid Leaves (Annual, Sick, Compassionate, Local Public, Marriage, Maternity, Paternity, Medical leave) Medical benefits ( Insurance and Annual Health Check-up) Pension and Insurance Policies (Group Term Life Insurance, Group Personal Accident Insurance, Travel Insurance) Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme) Additional Benefits (Long Service Awards, Mobile Phone Reimbursement) Company bonus/Profit share.DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity. About You Candidates must have a minimum 4 years’ work experience (full time) in an In-Vitro diagnostic medical device related industry, academia or hospital environment, with at least 2 of these years in the Assessment of Performance evaluation data, including Scientific Validity and Clinical Performance, or conducting performance evaluation studies for IVD devices. A PhD in a relevant area for IVD medical devices can substitute 3 years of work experience provided that it includes 2 years’ experience in Performance evaluation. Personal Qualities Analytical approach. Strong communication skills. Customer focus. Excellent reporting skills. Ability to work independently and efficiently. Ability to form recommendations on certification in complex cases.

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4.0 years

0 Lacs

Greater Kolkata Area

On-site

About Us We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence. As a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations. About SCPA We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers. About The Role As part of our continued growth, we are looking to recruit technical and experienced In-Vitro Diagnostic Medical Device Assessors and Lead Auditors. The successful candidates will be responsible for planning and conducting audits / assessments against the manufacturing of medical devices, in accordance with ISO 13485, IVDR 2017/746 and MDSAP standards, enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards. Key Accountabilities: Assessor Conduct assessments (either desk-based or on client’s sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer communication. Conduct Technical File reviews specific for products being authorized. Complete all chargeable work within the required timeframes to ensure customer satisfaction and efficiency of the business. Complete specific projects in relation to IVDR procedures, processes, systems and documentation as requested by the Operations Manager. If required, undertake reviews of files and make certification decisions within target timescales and in line with DNV policies and accreditation/approval requirements. Key Accountabilities: Auditor Responsible to carry out audits of the manufacturer's quality management system (QMS) and of its suppliers and/or subcontractors when appropriate and to draw up records and reports on the corresponding audits. Conduct surveillance audits including follow-up activities in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships. Complete all chargeable work within the required timeframes to ensure customer satisfaction and efficiency of the business. Complete projects in relation to IVDR procedures, processes, systems and documentation as requested by the Operations Manager. If required, undertake reviews of files and make certification recommendations within target timescales and in line with DNV policies and accreditation/approval requirements. Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards. What we offer Flexible work arrangements for better work-life balance Generous Paid Leaves (Annual, Sick, Compassionate, Local Public, Marriage, Maternity, Paternity, Medical leave) Medical benefits ( Insurance and Annual Health Check-up) Pension and Insurance Policies (Group Term Life Insurance, Group Personal Accident Insurance, Travel Insurance) Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme) Additional Benefits (Long Service Awards, Mobile Phone Reimbursement) Company bonus/Profit share. *Benefits may vary based on position, tenure/contract/grade level* DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity. About You Assessors and Auditors shall have a technical college degree in a relevant product or medical area, as described below. In-Vitro Diagnostic devices: Biology or Microbiology Chemistry or Biochemistry Human Physiology Medical Technology or Biotechnology Medicine, Veterinary Medicine Biomedical science - e.g. haematology, virology, molecular diagnostics Nursing Pharmacy, Pharmacology, Toxicology Physiology Education In addition to a relevant educational degree, candidates must have a minimum 4 years’ work experience (full time) in an In-Vitro diagnostic medical device related industry, academia or hospital environment, with at least 2 of these years in the design, manufacturing, testing or use of the device in which they are qualified to Audit or Assessment, and/or experience as an assessor or auditor in a notified body. Specifically: Auditor - Practical experience in the quality management system and specific production process/technologies for the IVD medical devices. Assessor - Practical experience in conducting and/or assessing performance evaluation data or related scientific aspects with in-vitro diagnostic medical devices in one or more of the following areas Microbiology, Immunology, Genetic testing/Cancer Biology and Molecular Biology. A PhD in a relevant area for in-vitro diagnostic medical devices can substitute 3 years of work experience provided it includes 2 years’ experience in design, manufacture or testing. In addition to the above, knowledge of the following would be preferred: An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques. Work experience in positions with significant QA Regulatory or management systems responsibility. Experience with Harmonized medical device standards for In-Vitro diagnostic medical devices. Experience with Risk Management EN ISO 14971. Medical device experience from auditing/work. Experience auditing against recognized standards. Experience of working under own initiative and in planning and prioritizing workloads. Should have a flair for technical writing, essential for exhaustive report writing.

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4.0 years

0 Lacs

Hyderabad, Telangana, India

On-site

About Us We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence. As a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations. About SCPA We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers. About The Role As part of our continued growth, we are looking to recruit technical and experienced In-Vitro Diagnostic Medical Device Assessors and Lead Auditors. The successful candidates will be responsible for planning and conducting audits / assessments against the manufacturing of medical devices, in accordance with ISO 13485, IVDR 2017/746 and MDSAP standards, enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards. Key Accountabilities: Assessor Conduct assessments (either desk-based or on client’s sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer communication. Conduct Technical File reviews specific for products being authorized. Complete all chargeable work within the required timeframes to ensure customer satisfaction and efficiency of the business. Complete specific projects in relation to IVDR procedures, processes, systems and documentation as requested by the Operations Manager. If required, undertake reviews of files and make certification decisions within target timescales and in line with DNV policies and accreditation/approval requirements. Key Accountabilities: Auditor Responsible to carry out audits of the manufacturer's quality management system (QMS) and of its suppliers and/or subcontractors when appropriate and to draw up records and reports on the corresponding audits. Conduct surveillance audits including follow-up activities in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships. Complete all chargeable work within the required timeframes to ensure customer satisfaction and efficiency of the business. Complete projects in relation to IVDR procedures, processes, systems and documentation as requested by the Operations Manager. If required, undertake reviews of files and make certification recommendations within target timescales and in line with DNV policies and accreditation/approval requirements. Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards. What we offer Flexible work arrangements for better work-life balance Generous Paid Leaves (Annual, Sick, Compassionate, Local Public, Marriage, Maternity, Paternity, Medical leave) Medical benefits ( Insurance and Annual Health Check-up) Pension and Insurance Policies (Group Term Life Insurance, Group Personal Accident Insurance, Travel Insurance) Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme) Additional Benefits (Long Service Awards, Mobile Phone Reimbursement) Company bonus/Profit share. *Benefits may vary based on position, tenure/contract/grade level* DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity. About You Assessors and Auditors shall have a technical college degree in a relevant product or medical area, as described below. In-Vitro Diagnostic devices: Biology or Microbiology Chemistry or Biochemistry Human Physiology Medical Technology or Biotechnology Medicine, Veterinary Medicine Biomedical science - e.g. haematology, virology, molecular diagnostics Nursing Pharmacy, Pharmacology, Toxicology Physiology Education In addition to a relevant educational degree, candidates must have a minimum 4 years’ work experience (full time) in an In-Vitro diagnostic medical device related industry, academia or hospital environment, with at least 2 of these years in the design, manufacturing, testing or use of the device in which they are qualified to Audit or Assessment, and/or experience as an assessor or auditor in a notified body. Specifically: Auditor - Practical experience in the quality management system and specific production process/technologies for the IVD medical devices. Assessor - Practical experience in conducting and/or assessing performance evaluation data or related scientific aspects with in-vitro diagnostic medical devices in one or more of the following areas Microbiology, Immunology, Genetic testing/Cancer Biology and Molecular Biology. A PhD in a relevant area for in-vitro diagnostic medical devices can substitute 3 years of work experience provided it includes 2 years’ experience in design, manufacture or testing. In addition to the above, knowledge of the following would be preferred: An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques. Work experience in positions with significant QA Regulatory or management systems responsibility. Experience with Harmonized medical device standards for In-Vitro diagnostic medical devices. Experience with Risk Management EN ISO 14971. Medical device experience from auditing/work. Experience auditing against recognized standards. Experience of working under own initiative and in planning and prioritizing workloads. Should have a flair for technical writing, essential for exhaustive report writing.

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4.0 years

0 Lacs

Hyderabad, Telangana, India

On-site

About Us We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence. As a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations. About SCPA We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers. About The Role DNV Product Assurance AS is one of the leading Notified Bodies for IVD medical devices. The unit is entitled to carry out tasks related to conformity assessment of IVD medical devices with Regulation (EU) 2017/746 In Vitro Medical Devices before such products are placed on the market. The role of Clinical Assessor is to assess performance data supporting safety and performance of IVD medical devices. Main Tasks In This Role Are Performing assessment and preparing reports of clinical performance aspects of legal manufacturers' technical documentation according to the requirements given in the Regulation (EU) 2017/746. Evaluation of the summary of safety and performance reports for high-risk IVD medical devices. Review and approval of performance evaluation report and other relevant performance documentation for accuracy and compliance with the requirements in the Regulation (EU) 2017/746. Education And Competencies Required Clinical Assessors shall have a technical college degree in a relevant product or medical area, as described below. Biology or Microbiology Chemistry or Biochemistry Human Physiology Medical Technology or Biotechnology Medicine, Veterinary Medicine Biomedical science - e.g. haematology, virology, molecular diagnostics Nursing Pharmacy, Pharmacology, Toxicology Physiology What we offer A competitive compensation and benefit package DNV training and qualification program A professional community in a prestigious technological company Possibilities to work with interesting and challenging projects Access to an extensive competence network Flexible work arrangements for better work-life balance Generous Paid Leaves (Annual, Sick, Compassionate, Local Public, Marriage, Maternity, Paternity, Medical leave) Medical benefits ( Insurance and Annual Health Check-up) Pension and Insurance Policies (Group Term Life Insurance, Group Personal Accident Insurance, Travel Insurance) Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme) Additional Benefits (Long Service Awards, Mobile Phone Reimbursement) Company bonus/Profit share.DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity. About You Candidates must have a minimum 4 years’ work experience (full time) in an In-Vitro diagnostic medical device related industry, academia or hospital environment, with at least 2 of these years in the Assessment of Performance evaluation data, including Scientific Validity and Clinical Performance, or conducting performance evaluation studies for IVD devices. A PhD in a relevant area for IVD medical devices can substitute 3 years of work experience provided that it includes 2 years’ experience in Performance evaluation. Personal Qualities Analytical approach. Strong communication skills. Customer focus. Excellent reporting skills. Ability to work independently and efficiently. Ability to form recommendations on certification in complex cases.

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Apply

4.0 years

0 Lacs

Pune, Maharashtra, India

On-site

About Us We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence. As a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations. About SCPA We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers. About The Role As part of our continued growth, we are looking to recruit technical and experienced In-Vitro Diagnostic Medical Device Assessors and Lead Auditors. The successful candidates will be responsible for planning and conducting audits / assessments against the manufacturing of medical devices, in accordance with ISO 13485, IVDR 2017/746 and MDSAP standards, enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards. Key Accountabilities: Assessor Conduct assessments (either desk-based or on client’s sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer communication. Conduct Technical File reviews specific for products being authorized. Complete all chargeable work within the required timeframes to ensure customer satisfaction and efficiency of the business. Complete specific projects in relation to IVDR procedures, processes, systems and documentation as requested by the Operations Manager. If required, undertake reviews of files and make certification decisions within target timescales and in line with DNV policies and accreditation/approval requirements. Key Accountabilities: Auditor Responsible to carry out audits of the manufacturer's quality management system (QMS) and of its suppliers and/or subcontractors when appropriate and to draw up records and reports on the corresponding audits. Conduct surveillance audits including follow-up activities in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships. Complete all chargeable work within the required timeframes to ensure customer satisfaction and efficiency of the business. Complete projects in relation to IVDR procedures, processes, systems and documentation as requested by the Operations Manager. If required, undertake reviews of files and make certification recommendations within target timescales and in line with DNV policies and accreditation/approval requirements. Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards. What we offer Flexible work arrangements for better work-life balance Generous Paid Leaves (Annual, Sick, Compassionate, Local Public, Marriage, Maternity, Paternity, Medical leave) Medical benefits ( Insurance and Annual Health Check-up) Pension and Insurance Policies (Group Term Life Insurance, Group Personal Accident Insurance, Travel Insurance) Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme) Additional Benefits (Long Service Awards, Mobile Phone Reimbursement) Company bonus/Profit share. *Benefits may vary based on position, tenure/contract/grade level* DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity. About You Assessors and Auditors shall have a technical college degree in a relevant product or medical area, as described below. In-Vitro Diagnostic devices: Biology or Microbiology Chemistry or Biochemistry Human Physiology Medical Technology or Biotechnology Medicine, Veterinary Medicine Biomedical science - e.g. haematology, virology, molecular diagnostics Nursing Pharmacy, Pharmacology, Toxicology Physiology Education In addition to a relevant educational degree, candidates must have a minimum 4 years’ work experience (full time) in an In-Vitro diagnostic medical device related industry, academia or hospital environment, with at least 2 of these years in the design, manufacturing, testing or use of the device in which they are qualified to Audit or Assessment, and/or experience as an assessor or auditor in a notified body. Specifically: Auditor - Practical experience in the quality management system and specific production process/technologies for the IVD medical devices. Assessor - Practical experience in conducting and/or assessing performance evaluation data or related scientific aspects with in-vitro diagnostic medical devices in one or more of the following areas Microbiology, Immunology, Genetic testing/Cancer Biology and Molecular Biology. A PhD in a relevant area for in-vitro diagnostic medical devices can substitute 3 years of work experience provided it includes 2 years’ experience in design, manufacture or testing. In addition to the above, knowledge of the following would be preferred: An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques. Work experience in positions with significant QA Regulatory or management systems responsibility. Experience with Harmonized medical device standards for In-Vitro diagnostic medical devices. Experience with Risk Management EN ISO 14971. Medical device experience from auditing/work. Experience auditing against recognized standards. Experience of working under own initiative and in planning and prioritizing workloads. Should have a flair for technical writing, essential for exhaustive report writing.

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4.0 years

0 Lacs

Mumbai Metropolitan Region

On-site

About Us We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence. As a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations. About SCPA We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers. About The Role As part of our continued growth, we are looking to recruit technical and experienced In-Vitro Diagnostic Medical Device Assessors and Lead Auditors. The successful candidates will be responsible for planning and conducting audits / assessments against the manufacturing of medical devices, in accordance with ISO 13485, IVDR 2017/746 and MDSAP standards, enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards. Key Accountabilities: Assessor Conduct assessments (either desk-based or on client’s sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer communication. Conduct Technical File reviews specific for products being authorized. Complete all chargeable work within the required timeframes to ensure customer satisfaction and efficiency of the business. Complete specific projects in relation to IVDR procedures, processes, systems and documentation as requested by the Operations Manager. If required, undertake reviews of files and make certification decisions within target timescales and in line with DNV policies and accreditation/approval requirements. Key Accountabilities: Auditor Responsible to carry out audits of the manufacturer's quality management system (QMS) and of its suppliers and/or subcontractors when appropriate and to draw up records and reports on the corresponding audits. Conduct surveillance audits including follow-up activities in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships. Complete all chargeable work within the required timeframes to ensure customer satisfaction and efficiency of the business. Complete projects in relation to IVDR procedures, processes, systems and documentation as requested by the Operations Manager. If required, undertake reviews of files and make certification recommendations within target timescales and in line with DNV policies and accreditation/approval requirements. Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards. What we offer Flexible work arrangements for better work-life balance Generous Paid Leaves (Annual, Sick, Compassionate, Local Public, Marriage, Maternity, Paternity, Medical leave) Medical benefits ( Insurance and Annual Health Check-up) Pension and Insurance Policies (Group Term Life Insurance, Group Personal Accident Insurance, Travel Insurance) Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme) Additional Benefits (Long Service Awards, Mobile Phone Reimbursement) Company bonus/Profit share. *Benefits may vary based on position, tenure/contract/grade level* DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity. About You Assessors and Auditors shall have a technical college degree in a relevant product or medical area, as described below. In-Vitro Diagnostic devices: Biology or Microbiology Chemistry or Biochemistry Human Physiology Medical Technology or Biotechnology Medicine, Veterinary Medicine Biomedical science - e.g. haematology, virology, molecular diagnostics Nursing Pharmacy, Pharmacology, Toxicology Physiology Education In addition to a relevant educational degree, candidates must have a minimum 4 years’ work experience (full time) in an In-Vitro diagnostic medical device related industry, academia or hospital environment, with at least 2 of these years in the design, manufacturing, testing or use of the device in which they are qualified to Audit or Assessment, and/or experience as an assessor or auditor in a notified body. Specifically: Auditor - Practical experience in the quality management system and specific production process/technologies for the IVD medical devices. Assessor - Practical experience in conducting and/or assessing performance evaluation data or related scientific aspects with in-vitro diagnostic medical devices in one or more of the following areas Microbiology, Immunology, Genetic testing/Cancer Biology and Molecular Biology. A PhD in a relevant area for in-vitro diagnostic medical devices can substitute 3 years of work experience provided it includes 2 years’ experience in design, manufacture or testing. In addition to the above, knowledge of the following would be preferred: An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques. Work experience in positions with significant QA Regulatory or management systems responsibility. Experience with Harmonized medical device standards for In-Vitro diagnostic medical devices. Experience with Risk Management EN ISO 14971. Medical device experience from auditing/work. Experience auditing against recognized standards. Experience of working under own initiative and in planning and prioritizing workloads. Should have a flair for technical writing, essential for exhaustive report writing.

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4.0 years

0 Lacs

Mumbai Metropolitan Region

On-site

About Us We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence. As a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations. About SCPA We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers. About The Role DNV Product Assurance AS is one of the leading Notified Bodies for IVD medical devices. The unit is entitled to carry out tasks related to conformity assessment of IVD medical devices with Regulation (EU) 2017/746 In Vitro Medical Devices before such products are placed on the market. The role of Clinical Assessor is to assess performance data supporting safety and performance of IVD medical devices. Main Tasks In This Role Are Performing assessment and preparing reports of clinical performance aspects of legal manufacturers' technical documentation according to the requirements given in the Regulation (EU) 2017/746. Evaluation of the summary of safety and performance reports for high-risk IVD medical devices. Review and approval of performance evaluation report and other relevant performance documentation for accuracy and compliance with the requirements in the Regulation (EU) 2017/746. Education And Competencies Required Clinical Assessors shall have a technical college degree in a relevant product or medical area, as described below. Biology or Microbiology Chemistry or Biochemistry Human Physiology Medical Technology or Biotechnology Medicine, Veterinary Medicine Biomedical science - e.g. haematology, virology, molecular diagnostics Nursing Pharmacy, Pharmacology, Toxicology Physiology What we offer A competitive compensation and benefit package DNV training and qualification program A professional community in a prestigious technological company Possibilities to work with interesting and challenging projects Access to an extensive competence network Flexible work arrangements for better work-life balance Generous Paid Leaves (Annual, Sick, Compassionate, Local Public, Marriage, Maternity, Paternity, Medical leave) Medical benefits ( Insurance and Annual Health Check-up) Pension and Insurance Policies (Group Term Life Insurance, Group Personal Accident Insurance, Travel Insurance) Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme) Additional Benefits (Long Service Awards, Mobile Phone Reimbursement) Company bonus/Profit share.DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity. About You Candidates must have a minimum 4 years’ work experience (full time) in an In-Vitro diagnostic medical device related industry, academia or hospital environment, with at least 2 of these years in the Assessment of Performance evaluation data, including Scientific Validity and Clinical Performance, or conducting performance evaluation studies for IVD devices. A PhD in a relevant area for IVD medical devices can substitute 3 years of work experience provided that it includes 2 years’ experience in Performance evaluation. Personal Qualities Analytical approach. Strong communication skills. Customer focus. Excellent reporting skills. Ability to work independently and efficiently. Ability to form recommendations on certification in complex cases.

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4.0 years

0 Lacs

Vadodara, Gujarat, India

On-site

About Us We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence. As a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations. About SCPA We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers. About The Role As part of our continued growth, we are looking to recruit technical and experienced In-Vitro Diagnostic Medical Device Assessors and Lead Auditors. The successful candidates will be responsible for planning and conducting audits / assessments against the manufacturing of medical devices, in accordance with ISO 13485, IVDR 2017/746 and MDSAP standards, enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards. Key Accountabilities: Assessor Conduct assessments (either desk-based or on client’s sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer communication. Conduct Technical File reviews specific for products being authorized. Complete all chargeable work within the required timeframes to ensure customer satisfaction and efficiency of the business. Complete specific projects in relation to IVDR procedures, processes, systems and documentation as requested by the Operations Manager. If required, undertake reviews of files and make certification decisions within target timescales and in line with DNV policies and accreditation/approval requirements. Key Accountabilities: Auditor Responsible to carry out audits of the manufacturer's quality management system (QMS) and of its suppliers and/or subcontractors when appropriate and to draw up records and reports on the corresponding audits. Conduct surveillance audits including follow-up activities in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships. Complete all chargeable work within the required timeframes to ensure customer satisfaction and efficiency of the business. Complete projects in relation to IVDR procedures, processes, systems and documentation as requested by the Operations Manager. If required, undertake reviews of files and make certification recommendations within target timescales and in line with DNV policies and accreditation/approval requirements. Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards. What we offer Flexible work arrangements for better work-life balance Generous Paid Leaves (Annual, Sick, Compassionate, Local Public, Marriage, Maternity, Paternity, Medical leave) Medical benefits ( Insurance and Annual Health Check-up) Pension and Insurance Policies (Group Term Life Insurance, Group Personal Accident Insurance, Travel Insurance) Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme) Additional Benefits (Long Service Awards, Mobile Phone Reimbursement) Company bonus/Profit share. *Benefits may vary based on position, tenure/contract/grade level* DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity. About You Assessors and Auditors shall have a technical college degree in a relevant product or medical area, as described below. In-Vitro Diagnostic devices: Biology or Microbiology Chemistry or Biochemistry Human Physiology Medical Technology or Biotechnology Medicine, Veterinary Medicine Biomedical science - e.g. haematology, virology, molecular diagnostics Nursing Pharmacy, Pharmacology, Toxicology Physiology Education In addition to a relevant educational degree, candidates must have a minimum 4 years’ work experience (full time) in an In-Vitro diagnostic medical device related industry, academia or hospital environment, with at least 2 of these years in the design, manufacturing, testing or use of the device in which they are qualified to Audit or Assessment, and/or experience as an assessor or auditor in a notified body. Specifically: Auditor - Practical experience in the quality management system and specific production process/technologies for the IVD medical devices. Assessor - Practical experience in conducting and/or assessing performance evaluation data or related scientific aspects with in-vitro diagnostic medical devices in one or more of the following areas Microbiology, Immunology, Genetic testing/Cancer Biology and Molecular Biology. A PhD in a relevant area for in-vitro diagnostic medical devices can substitute 3 years of work experience provided it includes 2 years’ experience in design, manufacture or testing. In addition to the above, knowledge of the following would be preferred: An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques. Work experience in positions with significant QA Regulatory or management systems responsibility. Experience with Harmonized medical device standards for In-Vitro diagnostic medical devices. Experience with Risk Management EN ISO 14971. Medical device experience from auditing/work. Experience auditing against recognized standards. Experience of working under own initiative and in planning and prioritizing workloads. Should have a flair for technical writing, essential for exhaustive report writing.

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4.0 years

0 Lacs

Vadodara, Gujarat, India

On-site

About Us We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence. As a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations. About SCPA We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers. About The Role DNV Product Assurance AS is one of the leading Notified Bodies for IVD medical devices. The unit is entitled to carry out tasks related to conformity assessment of IVD medical devices with Regulation (EU) 2017/746 In Vitro Medical Devices before such products are placed on the market. The role of Clinical Assessor is to assess performance data supporting safety and performance of IVD medical devices. Main Tasks In This Role Are Performing assessment and preparing reports of clinical performance aspects of legal manufacturers' technical documentation according to the requirements given in the Regulation (EU) 2017/746. Evaluation of the summary of safety and performance reports for high-risk IVD medical devices. Review and approval of performance evaluation report and other relevant performance documentation for accuracy and compliance with the requirements in the Regulation (EU) 2017/746. Education And Competencies Required Clinical Assessors shall have a technical college degree in a relevant product or medical area, as described below. Biology or Microbiology Chemistry or Biochemistry Human Physiology Medical Technology or Biotechnology Medicine, Veterinary Medicine Biomedical science - e.g. haematology, virology, molecular diagnostics Nursing Pharmacy, Pharmacology, Toxicology Physiology What we offer A competitive compensation and benefit package DNV training and qualification program A professional community in a prestigious technological company Possibilities to work with interesting and challenging projects Access to an extensive competence network Flexible work arrangements for better work-life balance Generous Paid Leaves (Annual, Sick, Compassionate, Local Public, Marriage, Maternity, Paternity, Medical leave) Medical benefits ( Insurance and Annual Health Check-up) Pension and Insurance Policies (Group Term Life Insurance, Group Personal Accident Insurance, Travel Insurance) Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme) Additional Benefits (Long Service Awards, Mobile Phone Reimbursement) Company bonus/Profit share.DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity. About You Candidates must have a minimum 4 years’ work experience (full time) in an In-Vitro diagnostic medical device related industry, academia or hospital environment, with at least 2 of these years in the Assessment of Performance evaluation data, including Scientific Validity and Clinical Performance, or conducting performance evaluation studies for IVD devices. A PhD in a relevant area for IVD medical devices can substitute 3 years of work experience provided that it includes 2 years’ experience in Performance evaluation. Personal Qualities Analytical approach. Strong communication skills. Customer focus. Excellent reporting skills. Ability to work independently and efficiently. Ability to form recommendations on certification in complex cases.

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0.0 - 5.0 years

40 - 50 Lacs

Goalpara, Sonipat, Gurugram

Work from Office

Anaesthesiologist Required Gadchiroli Maharashtra Salary 3 to 3.5 Lakhs + Accommodation + Food Sonipat Haryana For ICU IDCCM Preferred Salary 3 to 4 Lakhs Bharatpur Rajasthan Salary 3.5 Lakhs + Acco Gurgaon Haryana Salary 2 Lakhs + Share Required Candidate profile Goalpara, Assam Salary 4 Lakhs + Accommodation Neemrana, Rajasthan Salary 3.5 - 4 Lakhs + Accommodation Bhiwani Haryana Salary 2.5 to 3 Lakhs + Accommodation

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0 years

0 Lacs

Bengaluru, Karnataka, India

On-site

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast track career where you can grow along with Indegene’s high-speed growth. We are purpose-driven. We enable healthcare organizations be future ready and our customer obsession is our driving force . We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work. If this excites you, then apply below. Medical Reviewer You will be responsible for : PRINCIPAL RESPONSIBILITIES: Responsible for medical review of ICSRs for accuracy, medical relevance, and overall consistency of information captured in the safety database against all the applicable supporting documents as per the client requirement Evaluate adverse events (AE) report for seriousness, listedness and ensures that all medically relevant information from the source documents is included Assessment of reported AE and serious adverse events (SAE) providing company causality assessment utilizing clinical and global introspection methodologies aligned with global regulations. Reviews the case narrative, coding, product/Indication, labeling in accordance with the respective reference safety documents, causality and medical history for medical completeness, accuracy, and overall medical content. Provide medical sign off on the case. Perform line listing review of non-serious cases and evaluates the coding and labelling and confirm the events are evaluated correctly Perform unblinding activities as applicable Ensure appropriate follow-up questions/questionnaires are sent out based on the case. Perform Literature Surveillance when required Medical review of Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements Provide aggregate reviews of safety information, including but not limited to clinical data, post marketing, and literature review Tracking of inconsistencies on activities performed by data entry and QC reviewer as per the checklist and provide unbiased feedback, suggestions, points of improvement for attaining quality standards as per client expectations Responsible for following international pharmacovigilance regulations, company and department SOPs and department and function working practices. Contribute to pharmacovigilance and risk management planning for designated products by preparation of safety surveillance strategy and tracking and evaluating potential issues. Review safety assessments, risk/benefits evaluations, provide inputs and value add from medical perspective at all stages of safety Review, author and update standard operating procedures (SOP) and support in global initiatives for ensuring enhanced quality and compliance Communicate the observations to the applicable stakeholders and ensure the appropriate root cause analysis (RCA)/corrective action and preventive action (CAPA) Ensures follow up information is requested on relevant reports Present QA data to the responsible internal stakeholders in an appropriate forum as required Attend all the internal trainings and client trainings and ensure compliance with applicable guidelines Attend all the Governance and team meetings as required and appropriate Qualification : MBBS is required ( MCI registration is mandatory ) Your impact: About you: Must have: Cognitive abilities including verbal reasoning, attention to detail, critical thinking, scientific accuracy, and analytical ability. Ability to understand the purpose and requirements of a project. Good comprehension skills. Good communication and interpersonal skills. Drive quality and ensure team meets deadlines and commitments. Excellent mentoring and training skills. Knowledge of disease pathology and physiology, pharmacology and therapeutics. Familiarity with pharmaceutical industry principles of drug development and pharmacovigilance is preferred but not required. Very good understanding and track record in pharmacovigilance that can be applied and executed. Sound knowledge in pharmacovigilance safety database and compliance activities. EQUAL OPPORTUNITY Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate’s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.

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0.0 - 5.0 years

16 - 31 Lacs

Udaipur, Chandigarh, Lucknow

Work from Office

We require doctors for Medical Colleges & Hospitals PAN India Qual: MD/MS, DNB, (All Dept) Position: Consultant, SR, AP, Associate Professor, Professor Department: Clinical & Non Clinical Vishakha Call/Whatsapp: 9041008939 weps.services17@gmail.com

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5.0 - 9.0 years

0 Lacs

Hyderābād

On-site

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Business Systems Analyst - Law and Compliance Technology What you will do Let’s do this. Let’s change the world. The role demonstrates domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the software development teams. This role involves working closely with developers, business analysts and SaaS suppliers to ensure that the technical requirements for upcoming development are thoroughly elaborated. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will collaborate with Product Managers, developers and SaaS supplier teams to maintain an efficient and consistent process, ensuring quality work from the team. Roles & Responsibilities: Collaborate with System Architects, Product Managers and Suppliers to manage business analysis activities, ensuring alignment with engineering and product goals Capture the voice of the customer to define business processes and product needs Work with Product Managers and customers to define scope and value for new capabilities Ensure non-functional requirements are included and prioritized in the Product and Release Backlogs Facilitate the breakdown of Epics into Features and Sprint-Sized User Stories and participate in backlog reviews with the development team Clearly express features in User Stories/requirements so all team members and stakeholders understand how they fit into the product backlog Ensure Acceptance Criteria and Definition of Done are well-defined Stay focused on delivery to ensure product meets requirements, providing proactive feedback to stakeholders Develop and implement effective product demonstrations for internal and external stakeholders Maintain accurate documentation of configurations, processes, and changes Develop detailed test plans and strategies based on project requirements and specifications Perform manual and automated testing of software applications, including functional, regression, and performance testing Document and report defects and issues identified during testing, and work with development teams to resolve them Maintain detailed documentation of test plans, test cases, and test results Validate that test scenarios meet feature acceptance criteria and customer expectations Maintain and ensure the quality of documented user stories/requirements in tools such as Jira Serve as a liaison between global Technology and Artificial Intelligence and Data Teams and business stakeholders, prioritizing their needs and expectations Manage a suite of custom internal platforms, commercial off-the-shelf (COTS) software, Software-as-a-Service (SaaS) and systems integrations Identify and manage risks associated with the systems, including technological risks, system validation and user acceptance Leads coordination and tracking of system incidents, integration failures, and performance issues. Performs root cause analysis (RCA) in collaboration with business users and vendors to identify, document, and call out issues. Creates, manages, and follows up on tickets via vendor support portals for SaaS applications. Ensures high-priority incidents are addressed swiftly, with communication to business stakeholders and traceable resolution paths. Understands the impact of system incidents on legal workflows and data integrity, and acts promptly to mitigate business disruption. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master's degree / Bachelor's degree and 5 to 9 years of Life Science/Biotechnology/Pharmacology/Information Systems experience Must-Have Skills Excellent problem-solving skills and a passion for tackling complex challenges with technology Experience with Agile software development methodologies (Scrum) Good communication skills and the ability to collaborate with leadership with confidence and clarity Experience in writing requirements for development of modern web application Has experience with writing user requirements and acceptance criteria in agile project management systems such as JIRA Strong knowledge SharePoint including ability to produce and manage sites, document libraries, user access, SharePoint forms, and basic workflows. Preferred Qualifications: Good-to-Have Skills: Demonstrated expertise in Legal and / or Compliance technology Understanding of software systems strategy, governance, and infrastructure Experience in managing product features for PI planning and developing product roadmaps and user journeys Familiarity with low-code, no-code test automation software Able to communicate technical or complex subject matters in business terms Jira Align experience Experience using Lucidchart / Visio for creating process flows, traceability maps, and system diagrams. Experience with Microsoft Power Platform: Power BI, Power Automate, Power Apps. Experience with Tableau or equivalent data visualization tools. Experience with OpenAI tools for data mapping and structured content generation. Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams. High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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0.0 - 5.0 years

15 - 30 Lacs

Udaipur, Jaipur

Work from Office

Hiring SR/AP Professor Ophthalmology Pediatrician General Medicine Surgeon Orthopedic Gynecology Emergency Medicine Anesthesia Community medicine Radiology Pharmacology Forensic Biochemistry Physiology for Medical College in Jaipur & Udaipur

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