731 Ich-Gcp Guidelines Jobs - Page 8

Gather and influence eCOA design specifications from Clinical Trial Protocol to enable successful trial design and implementation As a Clinical database programmer, build, program and test Clinical trial data collection systems (eCOA database) and associated data repository mappings for a trial or set of trials within a program using data standards library components Ensure Clinical data collection systems and data warehouse mappings are delivered accurately, efficiently and in alignment with study objectives Partner with translation vendors to implement localized data collection in country specific language Partner with Clinical Build Programmer to ensure complete data build for trial data ...

Associate - Clinical Quality Assurance (CQA) Department: QA - MakroCare and DDi Job Roles and Responsibilities: Perform maintenance, review, and approval of company Standard Operating Procedures (SOPs) in compliance with ISO standards and applicable international and national regulations. Prepare and review Quality Management System (QMS) documents, CQA procedures, and assist in reviewing department SOPs as needed. Manage SOPs in mLMS, create users, review training records, and escalate non-compliance issues to the Head of CQA or relevant department heads. Maintain the CQA document repository and archive validation protocols and documents in line with regulatory requirements. Conduct interna...

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. Overview Trial Master File (TMF) Quality Control (QC) Specialist plays a critical role in ensuring the accuracy, completeness, and compliance of the TMF, which is the central repository of essential documents for a clinical trial. TMF Quality Control Specialists wi...

About The Role Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years What would you do? Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model powered by data, intelligent technologies and talentLooking for someone with AML and Fraud mgmt experience.Understand & implement laws, and regulations designed to stop the practice of generating income through illegal actions during transfer of funds. Anti Money Laundering law covers limited number of transactions and criminal behaviors to prevent terrorist financing an...

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Delivery Lead Manager Qualifications: MD Years of Experience: 13 to 18 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patie...

Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance Analyst Qualifications: Any Graduation Years of Experience: 3 to 5 years What would you do? Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model powered by data, intelligent technologies and talentLooking for someone with AML and Fraud mgmt experience.Understand & implement laws, and regulations designed to stop the practice of generating income through illegal actions during transfer of funds. Anti Money Laundering law covers limited number of transactions and criminal behaviors to prevent terrorist financing and money launderin...

Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Specialist Qualifications: BE/BTech/MCA Years of Experience: 7 to 11 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 vertica...

About The Role Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years What would you do? Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model powered by data, intelligent technologies and talentLooking for someone with AML and Fraud mgmt experience.Understand & implement laws, and regulations designed to stop the practice of generating income through illegal actions during transfer of funds. Anti Money Laundering law covers limited number of transactions and criminal behaviors to prevent terrorist financin...

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: Bachelor of Pharmacy,BSc. Nursing,Bachelor of Physiotheraphy Years of Experience: 1 to 2 year 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.accentu...

Extensive knowledge and application of ALCOA+ standards, Good Clinical Practice, Good Documentation Practices and International Council for Harmonization guidelines (E6(R2)) Critical thinker: Utilizing an intellectually disciplined process of actively and skillfully conceptualizing, applying, analyzing, synthesizing and/or evaluating information gathered from, or generated by, experience, reasoning or communication that will be instrumental in the decision-making process for quality review. Experience managing clinical content in a records management system or electronic Trial Master File system. Have strong communication skills, verbal and written. Experience Requirements: At least 3-5 year...

We are looking for a skilled Medical Writer with 5-10 years of experience to join our team in Hyderabad. The ideal candidate will have excellent writing and editing skills, with the ability to create clear, concise, and engaging content. Roles and Responsibility Develop high-quality medical content, including articles, blogs, and other written materials. Conduct research and analyze complex scientific concepts to create accurate and informative content. Collaborate with cross-functional teams to ensure consistency and quality of content. Edit and proofread content for clarity, grammar, and punctuation. Stay up-to-date with industry trends and developments in medical science and technology. P...

About The Role Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to li...

About The Role Skill required: KYC Screening - Sanctions Screening Designation: Regulatory Compliance Senior Analyst Qualifications: Any Graduation Years of Experience: 5 to 8 years What would you do? Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model powered by data, intelligent technologies and talentLooking for someone with AML and Fraud mgmt experience.Understand & implement laws, and regulations designed to stop the practice of generating income through illegal actions during transfer of funds. Anti Money Laundering law covers limited number of transactions and criminal behaviors to prevent terrorist financing an...

About The Role Skill required: KYC Screening - Sanctions Screening Designation: Regulatory Compliance Analyst Qualifications: Any Graduation Years of Experience: 3 to 5 years What would you do? Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model powered by data, intelligent technologies and talentLooking for someone with AML and Fraud mgmt experience.Understand & implement laws, and regulations designed to stop the practice of generating income through illegal actions during transfer of funds. Anti Money Laundering law covers limited number of transactions and criminal behaviors to prevent terrorist financing and money...

About The Role Skill required: KYC Screening - Sanctions Screening Designation: Regulatory Compliance New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years What would you do? Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model powered by data, intelligent technologies and talentLooking for someone with AML and Fraud mgmt experience.Understand & implement laws, and regulations designed to stop the practice of generating income through illegal actions during transfer of funds. Anti Money Laundering law covers limited number of transactions and criminal behaviors to prevent terrorist financing and...

About The Role Skill required: KYC Screening - Sanctions Screening Designation: Regulatory Compliance Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years What would you do? Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model powered by data, intelligent technologies and talentLooking for someone with AML and Fraud mgmt experience. Understand & implement laws, and regulations designed to stop the practice of generating income through illegal actions during transfer of funds. Anti Money Laundering law covers limited number of transactions and criminal behaviors to prevent terrorist financing and mo...

Our Team: Sanofi Business Operations (SBO) is an internal Sanofi resource organization setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions SBO 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 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 c...

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,...

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

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 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...

Roles and Responsibility Collaborate with cross-functional teams to develop and implement clinical trial protocols. Provide medical expertise and guidance on clinical research studies, including protocol development and review. Conduct site feasibility assessments and coordinate with investigators to ensure successful study execution. Develop and maintain relationships with key stakeholders, including sponsors, investigators, and regulatory agencies. Stay updated with changing regulations and guidelines governing clinical research, ensuring compliance and adherence to best practices. Participate in quality assurance activities to ensure high-quality deliverables. Job Requirements Strong unde...

Roles and Responsibility Manage and maintain accurate and up-to-date clinical trial data. Develop and implement effective data management plans and procedures. Collaborate with cross-functional teams to ensure data quality and integrity. Analyze and resolve complex data-related issues and discrepancies. Ensure compliance with regulatory requirements and industry standards. Provide training and support to junior staff members on data management best practices. Job Requirements Strong knowledge of clinical data management principles and practices. Experience with data analysis and reporting tools such as SAS or R. Excellent problem-solving skills and attention to detail. Ability to work effect...