417 Ich-Gcp Guidelines Jobs - Page 13

Job Summary The Sr Product Specialist (ISG) will play a crucial role in enhancing and managing our Veeva CTMS and Veeva systems within the Research and Development domain. With a hybrid work model and day shifts the candidate will collaborate with cross-functional teams to ensure seamless integration and functionality of these systems. This role requires a deep understanding of Veeva technologies and R&D processes to drive innovation and efficiency. Responsibilities Lead the implementation and optimization of Veeva CTMS and Veeva systems to support R&D activities. Oversee system configurations and ensure alignment with business requirements. Collaborate with stakeholders to gather and analyz...

Medical Review Scientist What you will do Let’s do this. Let’s change the world. In this vital role you will provide medical review of individual case safety reports (ICSRs) in support of safety surveillance for Amgen products To support global individual case safety reports regulatory reporting compliance To assure medical validity of ICSRs and provide input to the activities of Medical Safety Review Team (MSRT) To implement the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports To act as a significant point of contact for Case Management on medical content of ICSRs Execute the medical review of ICSRs (narratives, coding, expected...

Medical Review Senior Associate Scientist What you will do Let’s do this. Let’s change the world. In this vital role you will provide medical review of individual safety case reports (ICSR) in support of safety surveillance for Amgen products. Responsibilities: To support global individual case safety reports regulatory reporting compliance. To assure medical validity of ICSRs and provide input to the activities of Medical Safety Review Team (MSRT) Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. To act as a point of contact for Case Management on medical content of ICSRs Execute the medical review of ICSRs (narrativ...

What you will do Let’s do this. Let’s change the world. In this vital role you will author and gain approval of scientific and regulatory submission documents that align with global regulatory standards. To maintain key business relationships with appropriate cross-functional product team members. As requested, this role may serve as functional area lead on product teams, manage (with supervision) writing activities for product submissions, train and mentor more junior writers, and assist with departmental activities. Roles & Responsibilities: Author regulatory submission documents, as assigned, including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Prot...

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Bachelor in Physiotherapy/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 tech...

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 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 i...

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 mor...

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 ...

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 ...

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...

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...

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 pra...

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 pa...

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 pa...

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 tec...

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. W...

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. W...

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 an...

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 repor...

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 da...

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 h...

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 infor...

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 de...

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 ...