Veeva Safety Specialist
Boston, MA · On-site
Job Summary: * The Veeva Safety Specialist will be responsible for the implementation, administration, configuration, and ongoing support of Veeva Vault Safety solutions within a pharmaceutical or ...
60 Katalyst Jobs Hiring in Boston, MA
Veeva Safety Specialist
Boston, MA · On-site
Job Summary: * The Veeva Safety Specialist will be responsible for the implementation, administration, configuration, and ongoing support of Veeva Vault Safety solutions within a pharmaceutical or ...
Summary : • Strong experience holding the responsibility and relevant experience in the global pharmaceutical industry in functions such as Clinical Operations, Data Management and Statistics, with ...
Summary : • Strong experience holding the responsibility and relevant experience in the global pharmaceutical industry in functions such as Clinical Operations, Data Management and Statistics, with ...
* The Global Regulatory Affairs (GRA) is responsible for obtaining approval for new products and ensuring that approval is maintained throughout the product lifecycle. * GRA serves as the interface ...
* The Global Regulatory Affairs (GRA) is responsible for obtaining approval for new products and ensuring that approval is maintained throughout the product lifecycle. * GRA serves as the interface ...
Responsibilities: * Collect, enter, and manage clinical trial data using electronic data capture (EDC) systems. * Perform data validation and query management to ensure data quality and compliance ...
Responsibilities: * Collect, enter, and manage clinical trial data using electronic data capture (EDC) systems. * Perform data validation and query management to ensure data quality and compliance ...
* Our client is seeking an experienced Regulatory Operations Consultant to support Veeva Vault RIM, with a primary focus on archiving legacy regulatory content and mitigating documentation into Veeva ...
* Our client is seeking an experienced Regulatory Operations Consultant to support Veeva Vault RIM, with a primary focus on archiving legacy regulatory content and mitigating documentation into Veeva ...
Job Summary: * We are seeking an experienced GxP System Engineer with strong expertise in Hamilton Instrumentation, laboratory automation systems, and Computer System Validation (CSV) within a ...
Job Summary: * We are seeking an experienced GxP System Engineer with strong expertise in Hamilton Instrumentation, laboratory automation systems, and Computer System Validation (CSV) within a ...
Responsibilities: * Lead the development, validation, and documentation of CDISC-compliant SDTM and ADaM datasets for CNS clinical trials, ensuring traceability from raw data through analysis outputs.
Responsibilities: * Lead the development, validation, and documentation of CDISC-compliant SDTM and ADaM datasets for CNS clinical trials, ensuring traceability from raw data through analysis outputs.
Clinical Development Scientist
Boston, MA · On-site
Job overview: Clinical Development Lead to focus on study design strategy for the development of clinical study protocols and support the clinical operations team with study execution. Apply ...
Clinical Development Scientist
Boston, MA · On-site
Job overview: Clinical Development Lead to focus on study design strategy for the development of clinical study protocols and support the clinical operations team with study execution. Apply ...
Responsibilities: * Contribute to the review, interpretation and communication of scientific data pertaining to the efficacy and safety of compounds in development. * Attends congress and reviews ...
Responsibilities: * Contribute to the review, interpretation and communication of scientific data pertaining to the efficacy and safety of compounds in development. * Attends congress and reviews ...
Validation Engineer
Cambridge, MA · On-site
Roles & Responsibilities: * We are seeking a seasoned Validation Engineer with 10+ years of experience in medical device or regulated manufacturing environments. * Candidates must have strong hands ...
Validation Engineer
Cambridge, MA · On-site
Roles & Responsibilities: * We are seeking a seasoned Validation Engineer with 10+ years of experience in medical device or regulated manufacturing environments. * Candidates must have strong hands ...
* You are responsible for managing activities related to post-market product safety surveillance and risk management. * Serves as a liaison between Medical Affairs, Clinical Affairs, Research ...
New
* You are responsible for managing activities related to post-market product safety surveillance and risk management. * Serves as a liaison between Medical Affairs, Clinical Affairs, Research ...
New
Roles & Responsibilities : * Validate and maintain cloud-based enterprise systems including Oracle Fusion Cloud ERP, serialization platforms (Tracelink, Antares), and electronic quality management ...
Roles & Responsibilities : * Validate and maintain cloud-based enterprise systems including Oracle Fusion Cloud ERP, serialization platforms (Tracelink, Antares), and electronic quality management ...
We are seeking a highly motivated and passionate Scientist to join the Immunology Discovery team based in Cambridge, MA. The ideal candidate will contribute to the discovery and development of Client ...
We are seeking a highly motivated and passionate Scientist to join the Immunology Discovery team based in Cambridge, MA. The ideal candidate will contribute to the discovery and development of Client ...
Roles & Responsibilities: * 8 years of experience in validating GxP-regulated systems and your strong skills in risk assessment and protocol generation, bring a wealth of expertise that aligns ...
Roles & Responsibilities: * 8 years of experience in validating GxP-regulated systems and your strong skills in risk assessment and protocol generation, bring a wealth of expertise that aligns ...
NPI Project Manager
Boston, MA · On-site
Summary: We are seeking a proactive and detail-oriented NPI Project Engineer to lead the end-to-end execution of small to medium, cross-functional product development projects--from early concept ...
NPI Project Manager
Boston, MA · On-site
Summary: We are seeking a proactive and detail-oriented NPI Project Engineer to lead the end-to-end execution of small to medium, cross-functional product development projects--from early concept ...
Manufacturing Engineer
Danvers, MA · On-site
$77.20K - $99.40K/yr
* We are seeking a skilled Medical Device Manufacturing Engineer to support manufacturing validation, inspection methods, and quality documentation activities within a regulated medical device ...
Manufacturing Engineer
Danvers, MA · On-site
$77.20K - $99.40K/yr
* We are seeking a skilled Medical Device Manufacturing Engineer to support manufacturing validation, inspection methods, and quality documentation activities within a regulated medical device ...
* Candidate must have an active US Passport as there is travel, mostly domestic but some international. * Clinical Development Lead to focus on study design strategy for the development of clinical ...
* Candidate must have an active US Passport as there is travel, mostly domestic but some international. * Clinical Development Lead to focus on study design strategy for the development of clinical ...
IT CSV & CQV Validation Lead
Boston, MA · On-site
Responsibilities: Documentation & Deliverables: * Develop and author comprehensive validation and quality documentation, including protocols, reports, risk assessments, SOPs, and other project ...
IT CSV & CQV Validation Lead
Boston, MA · On-site
Responsibilities: Documentation & Deliverables: * Develop and author comprehensive validation and quality documentation, including protocols, reports, risk assessments, SOPs, and other project ...
Responsibilities: * Our client is a global immunology company committed to improving the lives of individuals who have severe autoimmune diseases with their Client antibody-based medicines. * They ...
Responsibilities: * Our client is a global immunology company committed to improving the lives of individuals who have severe autoimmune diseases with their Client antibody-based medicines. * They ...
Business System Specialist
Boston, MA · On-site
Objectives/purpose: * Work with GDO, R&D and cross-functional stakeholders to collect functional requirements for clinical and operational system data transfers. * Work with the Business System Owner ...
Business System Specialist
Boston, MA · On-site
Objectives/purpose: * Work with GDO, R&D and cross-functional stakeholders to collect functional requirements for clinical and operational system data transfers. * Work with the Business System Owner ...
Katalyst Jobs Information
What is it like to work at Katalyst?
Katalyst appears to be a collaborative and innovative company that values creativity and teamwork, fostering an environment where employees can share ideas and work together to achieve common goals.
The company's structure and work environment seem to be designed to support a dynamic and agile approach, with a focus on delivering high-quality results and driving business growth. Katalyst's mission is centered around helping businesses and organizations succeed through strategic partnerships and tailored solutions.
Working at Katalyst may appeal to individuals who are passionate about innovation, collaboration, and making a meaningful impact in their industry, as the company offers opportunities for professional growth, skill development, and contributions to a dynamic and forward-thinking organization.
The company's structure and work environment seem to be designed to support a dynamic and agile approach, with a focus on delivering high-quality results and driving business growth. Katalyst's mission is centered around helping businesses and organizations succeed through strategic partnerships and tailored solutions.
Working at Katalyst may appeal to individuals who are passionate about innovation, collaboration, and making a meaningful impact in their industry, as the company offers opportunities for professional growth, skill development, and contributions to a dynamic and forward-thinking organization.
What are the most popular jobs at Katalyst?
What are the most popular categories at Katalyst?
Job description
Job Summary:
- The Veeva Safety Specialist will be responsible for the implementation, administration, configuration, and ongoing support of Veeva Vault Safety solutions within a pharmaceutical or life sciences environment.
- This role involves managing safety processes, resolving system issues, supporting regulatory compliance activities, and ensuring smooth operation of safety workflows on the Veeva Vault platform.
- The specialist will collaborate with cross-functional teams to support pharmacovigilance operations, system enhancements, audit readiness, and compliance initiatives while maintaining high standards of GxP compliance and data integrity.
- Administer, configure, and maintain Veeva Vault Safety applications, including account management, workflows, issue resolution, transmission records, and regulatory submissions.
- Support implementation and ongoing maintenance activities for Veeva Safety and related platform features.
- Manage and troubleshoot support tickets, system issues, and enhancement requests within the Veeva environment.
- Participate in SDLC activities, system updates, Release Impact Assessments (RIA), and validation support.
- Support safety and compliance processes, including change control, deviation management, CAPA workflows, periodic reviews, and user access reviews.
- Ensure system compliance with GxP and regulatory requirements for pharmacovigilance and safety operations.
- Collaborate with business users, IT teams, and stakeholders to gather requirements and implement system improvements.
- Monitor system performance and maintain system documentation, SOPs, and user manuals.
- Conduct user training sessions and provide end-user support for Veeva Safety applications.
- Analyze data, troubleshoot system issues, and provide data-driven recommendations for process improvements.
- Support audit and inspection readiness activities related to Veeva Safety and safety operations.
- Maintain effective communication and knowledge sharing across project and operational teams.
- Bachelor's or Master's degree in Engineering, Technology, Life Sciences, Pharmacy, or related field preferred.
- 10+ years of experience in Veeva Vault Safety administration, support, or implementation within pharmaceutical or life sciences organizations.
- Strong experience with Veeva Vault Safety, including workflow configuration, issue resolution, and regulatory submission processes.
- Good understanding of pharmacovigilance processes, including ICSR case processing and safety operations.
- Hands-on experience with SDLC processes, Release Impact Assessment (RIA), and Veeva platform features.
- Knowledge of GxP compliance, CAPA, deviation management, change control, and audit processes.
- Strong analytical, troubleshooting, and problem-solving skills.
- Excellent communication, documentation, and collaboration skills.
- Preferred Certifications:
- Veeva Technical Foundation Certification
- Administer Veeva Safety Certification