263 Ich-Gcp Guidelines Jobs - Page 9

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Associate Qualifications: Master of Pharmacy Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.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. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com 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 - Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The incumbent will perform the regulatory affairs LCM with Veeva skill set of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components.Collect, collate and evaluate the scientific data gathered as part of R & D. Advise on legal and scientific restraints and requirements. Ensure the organization`s products comply with current regulations. Example; Build regulatory submission strategy, author CMC documents, and health authority packages etc. What are we looking for Life Sciences Regulatory ServicesAbility to perform under pressureProblem-solving skillsDetail orientationResults orientationStrong analytical skillsLife Sciences Automation Enablement Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Master of Pharmacy

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Master of Pharmacy Years of Experience: 3 to 5 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.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. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com 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. Employees under this span will be a part of one of the sub-offerings - Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The incumbent will perform the regulatory affairs tasks of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components. Veeva Regulatory Suite experienceCollect, collate and evaluate the scientific data gathered as part of R & D. Advise on legal and scientific restraints and requirements. Ensure the organization`s products comply with current regulations. Example; Build regulatory submission strategy, author CMC documents, and health authority packages etc. What are we looking for Life Sciences Regulatory ServicesAbility to handle disputesAbility to manage multiple stakeholdersAbility to meet deadlinesAbility to perform under pressureAbility to work well in a teamLife Sciences Automation Enablement Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualification Master of Pharmacy

Skill required: Clinical Data Services - SDTM Mapping Designation: Clinical Data Svs Associate Qualifications: BE/Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.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. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com 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 patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.A standard structure for human clinical trial data tabulations and for nonclinical study data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA). What are we looking for Adaptable and flexibleAgility for quick learning Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification BE,Bachelor of Pharmacy,Master of Pharmacy

About Us Tsaaro Consulting's prime focus is on Data Privacy and Security Our team of specialist Data Privacy Consultants, Information Security Consultants, and penetration testers help and advise our Clients to make running a secure business easier with high efficiency Everything We do is tailored to the individual, and organisational requirements, aligned with their budget and resource challenges We take a pragmatic, risk-based approach to provide our clients with real-world, workable advice, guidance, and support That helps them to deal with a wide range of security and privacy-related challenges At Tsaaro, we adopt a pragmatic, risk-based strategy to deliver practical and effective advice By providing real-world guidance, support, and actionable recommendations, we confidently equip our clients to address a broad spectrum of security and privacy challenges Looking to take your career in a new, high-impact directionTsaaro Consulting is seeking for a highly skilled and experienced GRC Analyst, this role is for those eager to transition into data privacy and information security, with hands-on experience and mentorship from industry experts Responsibilities Assist in the development, implementation, and continuous improvement of the Information Security Management System (ISMS) in accordance with ISO 27001 standards Monitor and ensure compliance with ISO 27001, making sure controls are in place and effectively operating across the organization Conduct regular assessments to ensure adherence to regulatory, contractual, and internal security requirements Coordinate internal audits and provide support for external ISO 27001 audits Prepare documentation, assist with gathering evidence, and address findings to ensure timely closure of audit actions Maintain and update ISMS documentation, policies, and procedures Ensure that security controls, risk assessments, and audit records are accurately documented and up to date Support the delivery of security awareness and training programs related to ISO 27001 standards Foster a culture of security awareness across the organization Support incident response processes and prepare crisis management plans, ensuring incidents are logged, analysed, and resolved Participate in root cause analysis and implement corrective actions to prevent recurrence Collaborate with cross-functional teams to identify, assess, and prioritise security risks Assist in developing risk mitigation strategies and track the progress of risk treatment plans Proactively identify opportunities to enhance the ISMS framework, suggesting improvements to policies, processes, and tools to ensure they are efficient and effective Requirements Minimum of 2 years in Governance, Risk, and Compliance (GRC) roles, with a focus on ISMS and ISO 27001 Bachelors degree in Information Security, Computer Science, Business Administration, or a related field (preferred) Excellent analytical and problem-solving skills Strong understanding of regulatory requirements and industry standards related to information security Proficiency in risk assessment methodologies and risk management practices Strong communication and interpersonal skills Ability to work effectively both independently and as part of a team Experience with security incident response and crisis management Familiarity with data protection regulations and privacy laws Certification in ISO 27001 Lead Auditor or Lead Implementer (preferred) Experience in developing and delivering security awareness training programs Benefits Competitive salary and performance-based bonuses Professional development opportunities, including training and certifications Flexible working hours Collaborative and inclusive work environment Opportunity to work with a passionate team dedicated to making a difference in data privacy and security check(event) ; career-website-detail-template-2 => apply(record id,meta)" mousedown="lyte-button => check(event)" final-style="background-color:#6875E2;border-color:#6875E2;color:white;" final-class="lyte-button lyteBackgroundColorBtn lyteSuccess" lyte-rendered="">

About Us Tsaaro Consulting's prime focus is on Data Privacy and Security Our team of specialist Data Privacy Consultants, Information Security Consultants, and penetration testers help and advise our Clients to make running a secure business easier with high efficiency Everything We do is tailored to the individual, and organisational requirements, aligned with their budget and resource challenges We take a pragmatic, risk-based approach to provide our clients with real-world, workable advice, guidance, and support That helps them to deal with a wide range of security and privacy-related challenges At Tsaaro, we adopt a pragmatic, risk-based strategy to deliver practical and effective advice By providing real-world guidance, support, and actionable recommendations, we confidently equip our clients to address a broad spectrum of security and privacy challenges Looking to take your career in a new, high-impact directionTsaaro Consulting is seeking for a highly skilled and experienced GRC Analyst, this role is for those eager to transition into data privacy and information security, with hands-on experience and mentorship from industry experts Responsibilities Assist in the development, implementation, and continuous improvement of the Information Security Management System (ISMS) in accordance with ISO 27001 standards Monitor and ensure compliance with ISO 27001, making sure controls are in place and effectively operating across the organization Conduct regular assessments to ensure adherence to regulatory, contractual, and internal security requirements Coordinate internal audits and provide support for external ISO 27001 audits Prepare documentation, assist with gathering evidence, and address findings to ensure timely closure of audit actions Maintain and update ISMS documentation, policies, and procedures Ensure that security controls, risk assessments, and audit records are accurately documented and up to date Support the delivery of security awareness and training programs related to ISO 27001 standards Foster a culture of security awareness across the organization Support incident response processes and prepare crisis management plans, ensuring incidents are logged, analysed, and resolved Participate in root cause analysis and implement corrective actions to prevent recurrence Collaborate with cross-functional teams to identify, assess, and prioritise security risks Assist in developing risk mitigation strategies and track the progress of risk treatment plans Proactively identify opportunities to enhance the ISMS framework, suggesting improvements to policies, processes, and tools to ensure they are efficient and effective Requirements Minimum of 2 years in Governance, Risk, and Compliance (GRC) roles, with a focus on ISMS and ISO 27001 Bachelors degree in Information Security, Computer Science, Business Administration, or a related field (preferred) Excellent analytical and problem-solving skills Strong understanding of regulatory requirements and industry standards related to information security Proficiency in risk assessment methodologies and risk management practices Strong communication and interpersonal skills Ability to work effectively both independently and as part of a team Experience with security incident response and crisis management Familiarity with data protection regulations and privacy laws Certification in ISO 27001 Lead Auditor or Lead Implementer (preferred) Experience in developing and delivering security awareness training programs Benefits Competitive salary and performance-based bonuses Professional development opportunities, including training and certifications Flexible working hours Collaborative and inclusive work environment Opportunity to work with a passionate team dedicated to making a difference in data privacy and security check(event) ; career-website-detail-template-2 => apply(record id,meta)" mousedown="lyte-button => check(event)" final-style="background-color:#6875E2;border-color:#6875E2;color:white;" final-class="lyte-button lyteBackgroundColorBtn lyteSuccess" lyte-rendered="">

Deva Institute of Healthcare and Research Pvt Ltd is looking for Clinical Research Coordinator to join our dynamic team and embark on a rewarding career journey. Coordinate and manage clinical trials from initiation to completion, ensuring compliance with regulatory guidelines and study protocols Recruit, screen, and enroll study participants while maintaining accurate documentation and records Monitor patient safety, manage informed consent, and schedule follow-ups Communicate with investigators, sponsors, and regulatory authorities to ensure timely updates and reporting Maintain study supplies, track data collection, and support data analysis, ensuring high-quality and ethical research practices throughout the study

Skill required: Clinical Data Services - Clinical Data Management Designation: Clinical Data Svs Specialist Qualifications: Bachelor of Pharmacy Years of Experience: 7 to 11 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 world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. The role may require you to identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The role may also need expertise in managing clinical data management projects. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualifications Bachelor of Pharmacy

Skill required: Clinical Data Services - Clinical Data Management Designation: Clinical Data Svs Specialist Qualifications: Bachelor of Pharmacy Years of Experience: 7 to 11 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 world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. The role may require you to identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The role may also need expertise in managing clinical data management projects. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Roles and Responsibilities: Overall experience of 4+ years in Clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry preferred. o Participate in the lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. o Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders. o Facilitate interaction with end user on creating specifications and working with programmers or performing the programming activities for successful delivery. o Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, SAS, and JReview etc. preferred. o Good analytical and communication skills. Qualifications Bachelor of Pharmacy

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Bachelor of Physiotheraphy/BSc. Nursing Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.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. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com 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 patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for Ability to work well in a teamAdaptable and flexibleAgility for quick learning Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Bachelor of Physiotheraphy,BSc. Nursing

Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.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. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do :Experience working in Client On-boarding, Account Maintenance, Customer Identification Program (CIP) and Know Your Customer (KYC) processes.Conducting PEPs (Politically Exposed Persons) screening and adverse media checksProven analytical skills, problem solving ability, and a control mentality paired with meticulous attention to detail.Aptitude for building relationships and ability to communicate complex issues to a wide array of internal clients with differing levels of product experience.Self-motivated and proactive team player who takes ownership and accountability & has strong organizational skills as well as the ability to effectively manage competing priorities.Flexible and able to work well under pressure, manage high volumes, and collaborate with a global team while maintaining a positive attitude.Proficiency using the Microsoft Office Suite in particular Excel, PowerPoint and Microsoft Word.Looking for someone with KYC experience along with ECDD/OCDD knowledgeBusiness and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding and/or maintaining a business / customer relationship. This includes driving customer identification, customer due diligence & enhanced due diligence. What are we looking for Know Your Customer (KYC) OperationsRequirements:Educated to Degree LevelFamiliar with a wide range of external data sources and third-party systems to be covered as a part of the due diligence process.Relevant financial service experience, ideally within risk, compliance or financial crime.A good understanding of effective risk managementExperience of working with high-risk client groupsKnowledge of the regulatory environment is highly desirableStrong analytical ability and attention to detail and strong research skills and experience with the Internet and on-line research systemsDetail oriented, with the ability to work independently and multi-task effectivelyExcellent written and verbal communication skillsFlexible to work in rotation shifts, time management, and ability to prioritize and work effectively to tight deadlines Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.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. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do :Experience working in Client On-boarding, Account Maintenance, Customer Identification Program (CIP) and Know Your Customer (KYC) processes.Conducting PEPs (Politically Exposed Persons) screening and adverse media checksProven analytical skills, problem solving ability, and a control mentality paired with meticulous attention to detail.Aptitude for building relationships and ability to communicate complex issues to a wide array of internal clients with differing levels of product experience.Self-motivated and proactive team player who takes ownership and accountability & has strong organizational skills as well as the ability to effectively manage competing prioritiesFlexible and able to work well under pressure, manage high volumes, and collaborate with a global team while maintaining a positive attitude.Proficiency using the Microsoft Office Suite in particular Excel, PowerPoint and Microsoft WordBusiness and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding and/or maintaining a business / customer relationship. This includes driving customer identification, customer due diligence & enhanced due diligence. What are we looking for Know Your Customer (KYC) OperationsRequirements:Educated to Degree LevelFamiliar with a wide range of external data sources and third-party systems to be covered as a part of the due diligence process.Relevant financial service experience, ideally within risk, compliance or financial crime.A good understanding of effective risk managementExperience of working with high-risk client groupsKnowledge of the regulatory environment is highly desirableStrong analytical ability and attention to detail and strong research skills and experience with the Internet and on-line research systemsDetail oriented, with the ability to work independently and multi-task effectivelyExcellent written and verbal communication skillsFlexible to work in rotation shifts, time management, and ability to prioritize and work effectively to tight deadlines Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Hi, We are hiring for Leading ITES Company for Medical Writer Profile. Role & Responsibilities: Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. Share project timelines amongst the study team for the development of document. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. Review statistical analysis plans and table/figure/listing, when required. Ensure uniformity and consistency in the scientific content of the regulatory documents Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies. Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. Plan and organize project and non-project meetings, as and when required To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 56 b) To Apply for above Job Role ( Pune ) Type : Job Code # 57

Kamla Homes is looking for Officer- RA to join our dynamic team and embark on a rewarding career journey Prepare regulatory submissions for product approvals Ensure compliance with domestic and global regulations Monitor regulatory changes and update dossiers Coordinate with QA and production for alignment

Alcon Laboratories (India) Pvt. Ltd is looking for Associate I Safety Data Analyst to join our dynamic team and embark on a rewarding career journey. Processing requisition and other business forms, checking account balances, and approving purchases. Advising other departments on best practices related to fiscal procedures. Managing account records, issuing invoices, and handling payments. Collaborating with internal departments to reconcile any accounting discrepancies. Analyzing financial data and assisting with audits, reviews, and tax preparations. Updating financial spreadsheets and reports with the latest available data. Preparation of operating budgets, financial statements, and reports. Reviewing existing financial policies and procedures to ensure regulatory compliance. Providing assistance with payroll administration. Keeping records and documenting financial processe

Jubilant Organosys is looking for Executive - Pharmacovigilance to join our dynamic team and embark on a rewarding career journey. Assisting with the preparation of operating budgets, financial statements, and reports. Processing requisition and other business forms, checking account balances, and approving purchases. Advising other departments on best practices related to fiscal procedures. Managing account records, issuing invoices, and handling payments. Collaborating with internal departments to reconcile any accounting discrepancies. Analyzing financial data and assisting with audits, reviews, and tax preparations. Updating financial spreadsheets and reports with the latest available data. Reviewing existing financial policies and procedures to ensure regulatory compliance. Providing assistance with payroll administration. Keeping records and documenting financial processes.

Skill required: Group Core Benefits - Group Disability Insurance Designation: Insurance Operations Senior Analyst Qualifications: Bachelor of Dental Surgery/Bachelor of Pharmacy/Bachelor in Physiotherapy Years of Experience: 5 to 8 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.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. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do We help insurers redefine their customer experience while accelerating their innovation agenda to drive sustainable growth by transforming to an intelligent operating model. Intelligent Insurance Operations combines our advisory, technology, and operations expertise, global scale, and robust ecosystem with our insurance transformation capabilities. It is structured to address the scope and complexity of the ever-changing insurance environment and offers a flexible operating model that can meet the unique needs of each market segment.The benefits of having a strong core include injury prevention, reduction of back pain, improved lifting mechanics, balance, stability, and posture, as well as improved athletic performance.Group disability coverage is tied to employment. If change or loss of job, the coverage is not portable. The cost of group coverage can also change from year to year. It is a sort of insurance that pays out if a policyholder is unable to work and earn an income due to a disability. What are we looking for Ability to establish strong client relationshipAbility to handle disputesAbility to manage multiple stakeholdersAbility to meet deadlinesAbility to perform under pressure0-5 years of experience in Medical Underwriting work.Possess excellent medical knowledge, including a strong grasp of medical terminologies and complex and complex disease condition.Knowledge of MS Office Tools and good computer knowledge.Graduate/Postgraduate in Life Sciences, B. Pharma, Bachelor in Physiotherapy, BHMS.Open to flexible shifts based on business requirements.Good verbal & written communication skillsGood typing skills and attention to detail.Good time management skills. Ability to work independently Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shiftsEvaluating the eligibility of applicants seeking an insurance policy. Reviewing each person s medical history and other factors such as age.Calculating individual risk and determining appropriate coverage and premium amounts.Assessing the risk involved in insuring an individual.Reviewing application files for life & disability products policies and determining eligibility coverage, premium rates, and exclusion policies.Complies with all regulatory requirements, procedures, and Federal/State/Local regulations.Review medical reports, data, and other records to assess the risk involved in insuring a potential policyholder.Ensure Quality Control standards that have been set are adhered to.Excellent organizational skills with ability to identify and prioritize high value transactions.Completing assigned responsibilities and projects within timelines apart from managing daily BAU. Qualification Bachelor of Dental Surgery,Bachelor of Pharmacy,Bachelor in Physiotherapy

Job Summary We are seeking a Process Specialist with 4 to 5 years of experience in HealthCare Products to join our team. The ideal candidate will have expertise in Prov Privileges excl Hospital Demo Changes Credentialing and Re-credentialing by Calls . This role requires working in a hybrid model with night shifts. The candidate will play a crucial role in ensuring the smooth operation of healthcare processes and contribute to the overall efficiency and effectiveness of our services. Responsibilities Oversee the management of healthcare products to ensure compliance with industry standards and regulations. Provide expertise in Prov Privileges excl Hospital to maintain accurate provider information. Manage demo changes to ensure that all demographic data is up-to-date and accurate. Handle credentialing and re-credentialing processes to ensure that all providers meet the necessary qualifications and standards. Collaborate with various departments to streamline healthcare processes and improve overall efficiency. Conduct regular audits to ensure compliance with healthcare regulations and standards. Develop and implement process improvements to enhance the quality of healthcare services. Provide training and support to team members on healthcare processes and procedures. Monitor and analyze process performance to identify areas for improvement. Ensure that all healthcare processes are documented and maintained accurately. Work closely with healthcare providers to address any issues or concerns related to credentialing and privileges. Participate in the development and implementation of healthcare policies and procedures. Maintain up-to-date knowledge of industry trends and best practices in healthcare process management. Qualifications Possess a minimum of 4 years of experience in healthcare products management. Demonstrate expertise in Prov Privileges excl Hospital demo changes credentialing and re-credentialing. Have a strong understanding of healthcare regulations and standards. Exhibit excellent communication and collaboration skills. Show proficiency in process improvement methodologies. Display strong analytical and problem-solving abilities. Certifications Required Certified Provider Credentialing Specialist (CPCS) or equivalent certification is required.

ICON plc is a world-leading healthcare intelligence and clinical research organization Were proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development, Job Title: Manager, TMF Operation Location : Bangalore What You Will Be Doing Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs, To manage document management departmental activities for internal services or client services in accordance with client and study requirements, ICON SOPs/WPs and regulations, where applicable To inform department management of training issues, project activities, quality issues and timelines as directed, To ensure activity/status tracking is completed in accordance with department/client requirements Tracking includes: document receipt and review, scanning and indexing, quality control, copying, filing, forwarding or return to client/study teams and archiving, To ensure appropriate maintenance of document files and storage areas in accordance with ICON and/or client requirements and SOPs/WPS and applicable regulations as directed by the department head You Are Bachelors degree in life sciences, clinical research, or a related field Extensive experience in TMF management or clinical operations within the pharmaceutical or clinical research industry, Strong understanding of GCP, ICH guidelines, and global regulatory requirements related to TMF management and clinical trial documentation, Proven leadership skills, with experience managing and developing teams in a fast-paced, regulated environment, What ICON Can Offer You Our success depends on the quality of our people Thats why weve made it a priority to build a diverse culture that rewards high performance and nurtures talent, In addition to your competitive salary, ICON offers a range of additional benefits Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family, Our Benefits Examples Include Various annual leave entitlements A range of health insurance offerings to suit you and your familys needs Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your familys well-being Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: https://careers iconplc,com/benefits At ICON, inclusion & belonging are fundamental to our culture and values Were dedicated to providing an inclusive and accessible environment for all candidates ICON is committed to providing a workplace free of discrimination and harassment All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status, https://careers iconplc , com / reasonable-accommodations Interested in the role, but unsure if you meet all of the requirementsWe would encourage you to apply regardless theres every chance youre exactly what were looking for here at ICON whether it is for this or other roles,

Providing insights on industry and market developments, including policy and regulatory updates to advocate for favourable outcomes. Analysis of Regulations, Guidelines, Policies, Important order, etc. to derive meaningful insights & actionable for higher management. Support in Policy Advocacy, legal & regulatory on filing petitions with appropriate authority. Support in review of bidding, bid documents, RFS & PPA. Support in creation of Memorandums of Understanding (MOU) with government bodies, ensuring alignment with legal and strategic frameworks. Supporting business development and project expansion, ensuring alignment with ENGIEs strategy and objectives. Building positive relationships with stakeholders, associations, etc. through appropriate management of expectations and objectives, ensuring consistent and effective communication. Will handle the Invoicing, NFA, payment disbursement activities, etc. Draft representations, communication for various stakeholders. Additional Responsibilities: Supporting corporate communications efforts with different stakeholders. Monitoring key industry events and, ensuring ENGIEs participation at appropriate levels to enhance visibility and influence.

Job Responsibilities Lead and manage a research team in order to curate accurate, timely, insightful and comprehensive data and intelligence; Identify and analyze the most relevant information for Beacon and its users; Coordinate with UK based clients on a regular basis to understand and meet the project deliverables. Manage the activities required towards launch of a beacon module and further support the needs towards maintenance post launch. You will be part of a global network of life science researchers working on dynamic, fast growing products in exciting, cutting edge life science areas. Perform data management activities on the assigned project in a timely and efficient manner Generate queries to clarify and improve the quality of the data Strong understanding of Clinical Trials and their data Strong understanding on preclinical data What attributes will you need? An ideal candidate might be a subject matter expertise in various drug therapies in field of oncology (Antibody drug conjugate/Bispecific/Adoptive cell therapy/Checkpoint modulators/oncolytic virus/Gene therapy) and experience with managing a team of resources Proven ability to deal with complex life science concepts Excellent written and verbal communication skills. Previous experience in a research role and/or data-oriented role is desirable but not essential. Experience and understanding in the field of pharmacology, drug discovery and development and clinical trials would be a bonus. Good project and people management skills are a must have. Results-oriented, passionate about delivering value and impact, proactive Most of all, you will need to be curious and willing to learn at all times. Eligibility: Masters in Pharmacy (except Pharmacognosy)/Biology/Bio-Technology/Bio-Chemistry/Pharm D with minimum 2-3+ years of relevant experience Bachelors in Pharmacy (except Pharmacognosy)/Biology/Bio-Technology/Bio-Chemistry with at-least 4 years of relevant experience Candidates with additional Clinical research diploma or relevant courses can apply. Candidate should have basic computer skills, Microsoft Office & detailed Internet Knowledge. Candidate should have one research paper published Ability to work in a high-pressure, deadline-driven environment Exceptional communication and reporting skills

Job description Should have knowledge in clinical research studies Perform Site visits (i.e. Site Selection Visit, Site Initiation Visits, Site monitoring visits and site close-out visits) should have knowledge in ICH GCP Guidelines Required Candidate profile Minimum Bachelor's or Masters degree in related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research Are Applicable to Apply

Role & responsibilities: Ensures that qualified by education, training, and experience to assume responsibility for the proper conduct of the clinical studies. Maintaining current, up-to-date curriculum vitae . Assuming responsibility for the conduct of the clinical investigation. Signing the protocol Documenting the financial aspects of the trial. Disclosing conflicts of interest as described in the regulations. Ensuring adequate number of qualified staff and adequate facilities for conductance of the study properly and safely. Ensures that all persons assisting with the study are adequately informed about the protocol, the investigational product(s), and their study-related duties and functions. Ensuring that medical care is provided to a subject for any adverse event(s) that is reported. Informing a subject when medical care is needed to treat an inter-current illness. Provide information regarding adverse events and serious adverse events to the IRB/IEC. Possessing a thorough understanding of the requirements of each protocol . Ensuring recruitment goals are reasonable and attainable. Assessing overall protocol feasibility. Following the trials randomization procedures. Ensuring that the informed consent form contains the entire Essential and additional elements required. Conduct of the clinical studies specified by the applicable regulatory requirement(s), the IRB/IEC requirements and/or the regulatory authorities. Conduct the study as per the principles of ethics and is compliance with Good Clinical Practices (GCP). Attending education workshops. Reviewing professional publications. Participating in professional societies Maintaining a list of qualified persons and their corresponding trial-related delegated duties. Preferred candidate profile can send to email: hr@qpsbioserve.com or raghavendra.kundhula@qpsbioserve.com Perks and benefits: Nil

We are looking for a highly motivated and experienced Branch Receivable Officer to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 1-2 years of experience in the BFSI industry. Roles and Responsibility Manage and oversee the daily operations of the branch's receivables. Develop and implement strategies to improve collection efficiency and reduce delinquencies. Collaborate with internal teams to resolve customer complaints and issues related to payments. Analyze financial data to identify trends and areas for improvement in the bank's receivables. Ensure compliance with regulatory requirements and company policies. Maintain accurate records and reports of all transactions and interactions with customers. Job Requirements Strong knowledge of banking regulations and laws. Excellent communication and interpersonal skills. Ability to work effectively in a fast-paced environment and meet deadlines. Proficient in Microsoft Office and other software applications. Strong analytical and problem-solving skills. Ability to maintain confidentiality and handle sensitive information. Experience working in a similar role within the BFSI industry is preferred. Locaiton : - Arani,Chennai,Tiruvannamalai,Vellore

We are looking for a highly skilled and experienced Relationship Manager to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 2-4 years of experience in the BFSI industry, preferably in micro mortgages. Roles and Responsibility Manage relationships with existing clients to ensure timely payment of EMIs and minimize defaults. Identify new business opportunities through networking and referrals to expand the client base. Conduct site visits to assess client needs and provide personalized solutions. Develop and implement strategies to increase sales revenue from existing clients. Collaborate with internal teams to resolve customer queries and issues promptly. Maintain accurate records of client interactions and transactions. Job Requirements Strong knowledge of micro mortgage products and services. Excellent communication and interpersonal skills. Ability to work independently and as part of a team. Strong analytical and problem-solving skills. Proficiency in using technology and software applications. Experience in relationship management and sales is desirable.

We are looking for a highly skilled and experienced Operations Analyst to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 2 to 7 years of experience in document verification and be able to work efficiently in a fast-paced environment. Roles and Responsibility Verify documents for accuracy and completeness. Perform quality checks on verified documents. Collaborate with the operations team to resolve issues. Develop and implement process improvements to increase efficiency. Maintain high customer satisfaction through excellent service. Ensure compliance with regulatory requirements. Job Requirements Minimum 2 years of experience in document verification or a related field. Strong knowledge of document verification processes and procedures. Excellent analytical and problem-solving skills. Ability to work effectively in a team environment. Strong communication and interpersonal skills. Familiarity with operational analysis and process improvement techniques.