689 Meddra Jobs - Page 9

Main responsibilities: The overall purpose and main responsibilities are listed below: Responsible for project management support to the scientific writer ensuring the end-to-end effective project delivery of the designated publication/medical education deliverable across all phases. Initiate and amend submission based on comments (as required). Support the writer with internal and external stakeholder communication. Track the delivery of activities (including managing issues and risks) and support follow up. Support required submission, compliance/ approval activities, and ensure compliance with publication processes and end-to-end publication management tools (e.g., iEnvision - previously,...

Exp 4–6years in healthcare/pharma BPO ,U.S. Healthcare Technical Knowledge Proficiency in LOINC, ICD-10, CPT, NDC, RxNorm, SNOMED CT. Tools & terminology tools (Symedical, Clinical Architecture), EHR/EMR system Geetha : 9902419093

As a Medical Coding Specialist at Statistics & Data Corporation (SDC), you will be responsible for coordinating the coding of terms for clinical trials. Your role will involve manually encoding medical terms, ensuring consistency in coding across projects, and communicating effectively with the coding team and Manager, Medical Coding. **Key Responsibilities:** - Manually encode medical terms not automatically coded by the data management system - Ensure consistency in coding terms within and across projects - Communicate timely and effectively with coding team and Manager, Medical Coding regarding any issues, risks, concerns, or technical needs - Contribute to and review Data Management Plan...

Job Overview The RN Associate / Senior Associate, Clinical Data Management is responsible for delivering and overseeing clinical and patient reported data within electronic data capture (EDC) platforms, including iTakeControl. Activities include monitoring databases and video evidence, maintaining data quality, and database integrity for research studies from conception to closeout. The role will work closely with the Clinical Operations, Product Management and Technical Delivery teams and is responsible for detailed specification development, documentation, and supporting clinical operations, project management and delivery activities for Clinical and iTakeControl (iTC) product client proje...

Contribute to the creation and maintenance of risk management plans & provides support for the effective implementation of Additional Risk Minimisation measures. Safety mailbox and communications management. Support Aggregate Report related activities. Maintenance of PV Awareness and other related Training content. Implementation of Pharmacovigilance Agreements. Individual Case Safety Report (ICSR) related activities, including literature screening, and submissions to local Health Authorities and Ethics Committees. Safety Data Quality activities e. g. PV System Master File maintenance, deviations/CAPA management, other quality control and oversight activities. Compilation of PV-related docum...

Job Overview The Executive Pharmacovigilance will be responsible end-to-end case management, including case receipt, case follow-up,database entry, review and submission to applicable regulatory authorities within stipulated timelines. Required Candidate profile Any Pharmacy or Pharm D with Certification in Pharmacovigilance can Apply Should have Good Communication Skills Should have strong knowledge on Argus Safety Database and Case Processing and MedDRa

Perform triage & intake of ICSR received daily in ARGUS databases Should have hands On Experience On ARGUS Safety Database Should Have hands on Experience on MEDDRA Applicants Should Complete Certification in Pharmacoviiglance Required Candidate profile B.Pharm / M.Pharm/Pharm D/Life sciences degree With Hands On Experience On Argus Safety Database and Med DRA coding, Argus, Narrative Writing, Triage

We are looking for an experienced Medical Reviewer specializing in Pharmacovigilance and Drug Safety to ensure high-quality medical assessment and regulatory compliance of Individual Case Safety Reports (ICSRs) and drug safety documentation. Key Responsibilities: Conduct medical review of ICSRs , including spontaneous reports, literature cases, and clinical trial data, in adherence to client Standard Operating Procedures (SOPs) . Monitor drug safety updates and communicate necessary changes to pharmacovigilance teams involved in clinical trials. Ensure accurate case coding following MedDRA guidelines and regulatory compliance. Perform retrospective reviews of ICSR line listings within define...

Roles and Responsibility Monitor medical enquiries and respond to customer inquiries professionally. Provide excellent customer service and ensure high customer satisfaction. Collaborate with internal teams to resolve medical queries and concerns. Develop and maintain knowledge of medical terminology and procedures. Analyze data and trends to identify areas for improvement in medical enquiry monitoring. Implement process improvements to increase efficiency and productivity. Job Requirements Strong communication and interpersonal skills are essential. Ability to work effectively in a fast-paced environment and prioritize tasks. Basic computer skills and proficiency in Microsoft Office are req...

Roles and Responsibility Develop high-quality medical content for various platforms, including reports and presentations. Conduct research and analyze data to create accurate and informative medical documents. Collaborate with cross-functional teams to ensure consistency and quality of medical content. Create engaging and easy-to-understand medical information for patients and healthcare professionals. Stay updated with the latest medical trends and developments to improve content quality. Edit and review medical documents for accuracy, clarity, and adherence to standards. Job Requirements Minimum 2 years of experience in medical writing or a related field. Strong understanding of medical te...

Roles and Responsibility Develop comprehensive, accurate, and engaging medical documents, including reports, articles, and presentations. Conduct thorough research on various medical topics to stay updated with industry developments. Collaborate with cross-functional teams to ensure timely delivery of projects. Edit and review medical documents for clarity, grammar, and accuracy. Stay current with industry trends and advancements in medicine. Participate in quality assurance activities to maintain high standards of work. Job Requirements Minimum 8 years of experience in medical writing or a related field. Strong understanding of medical terminology, anatomy, and physiology. Excellent writing...

Roles and Responsibility Coordinate and manage regulatory submissions, ensuring compliance with relevant laws and regulations. Develop and implement effective submission strategies to achieve business objectives. Collaborate with cross-functional teams to ensure timely and accurate submissions. Conduct thorough reviews of submissions to identify areas for improvement. Maintain accurate records of submissions and follow up on pending submissions. Stay updated with changes in regulatory requirements and guidelines. Job Requirements Strong knowledge of regulatory submissions and compliance. Excellent communication and project management skills. Ability to work in a fast-paced environment and me...

Roles and Responsibility Develop and implement effective medical monitoring strategies for clinical trials. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Conduct regular reviews of medical data to identify trends and potential issues. Provide expert guidance on medical aspects of clinical development projects. Ensure timely reporting of medical information to stakeholders. Participate in quality improvement initiatives to enhance medical monitoring processes. Job Requirements Strong understanding of clinical development principles and regulations. Excellent analytical and problem-solving skills. Effective communication and collaboration skills. Ab...

Roles and Responsibility Publish regulatory submissions on time, ensuring accuracy and compliance with relevant regulations. Collaborate with cross-functional teams to prepare and review regulatory documents. Develop and maintain relationships with regulatory authorities and stakeholders. Stay updated with changes in regulatory requirements and implement necessary updates. Ensure all regulatory submissions meet required standards and quality criteria. Coordinate with internal teams to gather information and support for regulatory submissions. Job Requirements Strong knowledge of regulatory requirements and guidelines. Excellent communication and interpersonal skills. Ability to work independ...

Roles and Responsibility Conduct thorough medical reviews of patient data to ensure accuracy and compliance with regulatory requirements. Collaborate with cross-functional teams to identify and resolve issues related to medical review. Develop and implement effective strategies to improve medical review processes and outcomes. Provide expert guidance on medical review best practices to junior team members. Stay up-to-date with changing regulations and guidelines related to medical review. Participate in quality improvement initiatives to enhance medical review efficiency and effectiveness. Job Requirements Strong knowledge of medical terminology and regulatory requirements. Excellent analyti...

Roles and Responsibility Conduct thorough medical reviews of device-related documents, including clinical trial protocols and study reports. Collaborate with cross-functional teams to ensure compliance with regulatory requirements and industry standards. Develop and maintain expertise in medical devices and equipment, staying up-to-date on new technologies and trends. Provide guidance and support to junior staff members on medical review processes and procedures. Participate in quality improvement initiatives to enhance the efficiency and effectiveness of medical review activities. Communicate complex technical information effectively to non-technical stakeholders through written reports and...

Skill required: Pharmacovigilance Services - Safety Writing Designation: Pharmacovigilance Services Sr Analyst Qualifications: Bachelor of Pharmacy Years of Experience: 5 to 8 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D ...

Job title : Jr. Associate Evidence Synthesis Hiring Manager: Head/Group Lead/Research Lead/Team Lead Location: Hyderabad % of travel expected: Travel required as per business need Job type: Permanent and Full time About the job Our Team: Sanofi Global Hub is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. MedHub strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, Globally. Main responsibilities: The overall purpose and main responsibilities are listed belo...

Manage and oversee clinical study data management activities, ensuring compliance with regulatory requirements. Develop and implement effective data management plans to ensure data quality and integrity. Collaborate with cross-functional teams to identify and resolve data-related issues. Conduct regular audits to ensure adherence to data management standards. Provide training and support to junior staff members on data management best practices. Ensure timely delivery of high-quality results while maintaining attention to detail. Job Requirements Strong understanding of clinical trial conduct, including GCP guidelines and regulatory requirements. Experience with data management systems, such...

Manage and oversee the development, implementation, and maintenance of clinical databases. Ensure data quality, accuracy, and compliance with regulatory requirements. Collaborate with cross-functional teams to design and implement data-driven solutions. Develop and maintain data standards, policies, and procedures. Provide training and support to staff on data management systems. Identify and mitigate risks associated with data management. Job Requirements Strong knowledge of clinical data management principles and practices. Experience with clinical trial conduct and regulatory requirements. Excellent communication and interpersonal skills. Ability to work effectively in a fast-paced enviro...

Conduct thorough medical reviews of devices and their associated documentation. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Develop and maintain expertise in medical terminology and device regulations. Provide guidance on medical aspects of device development and implementation. Stay updated with changing trends and developments in medical technology. Participate in quality improvement initiatives to enhance review processes. Job Requirements Strong understanding of medical terminology and device regulations. Excellent analytical and problem-solving skills. Ability to work effectively in a team environment. Effective communication and interperso...

Develop and implement aggregate reporting solutions to meet business requirements. Collaborate with cross-functional teams to identify and prioritize reporting needs. Design and maintain complex reports using various reporting tools and technologies. Analyze data to identify trends and patterns, providing insights to stakeholders. Ensure data accuracy and integrity in all reports and dashboards. Provide training and support to end-users on reporting tools and technologies. Job Requirements Strong understanding of aggregate reporting principles and methodologies. Proficiency in designing and developing complex reports using various reporting tools and technologies. Excellent analytical and pr...

Conduct thorough analysis of clinical trial data to identify potential safety concerns. Develop and implement effective safety protocols to mitigate risks associated with medical devices. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Perform risk assessments and provide recommendations for improving patient safety. Monitor and report adverse events related to medical devices. Stay updated with changing regulations and guidelines related to clinical safety. Job Requirements Strong understanding of clinical trials, safety protocols, and regulatory requirements. Experience working with medical devices and their applications. Excellent analytical and ...

Manage and analyze aggregate reporting data to provide insights and recommendations. Develop and implement effective reporting strategies to meet business needs. Collaborate with cross-functional teams to ensure accurate and timely reporting. Identify and resolve issues related to reporting data quality and integrity. Develop and maintain complex reports using various reporting tools and technologies. Provide expert guidance on reporting best practices and standards. Job Requirements Strong understanding of aggregate reporting principles and methodologies. Proficiency in analyzing large datasets and providing actionable insights. Excellent communication and interpersonal skills, with the abi...

Develop and implement effective medical monitoring strategies for clinical trials. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Conduct thorough reviews of medical data to identify trends and potential issues. Provide expert guidance on medical aspects of clinical development projects. Ensure timely reporting of adverse events and other critical information. Participate in quality control activities to maintain high standards of data accuracy. Job Requirements Strong understanding of clinical development principles and practices. Excellent analytical and problem-solving skills, with attention to detail. Effective communication and interpersonal s...