4 Icsr Processing Jobs

What you will do In this vital role you will join a collaborative team implementing and supporting the next generation of safety platforms and supporting technologies. In this role, you will analyze and resolve issues with adverse event data and file transmissions across integrated systems, leveraging data analytics to identify trends, optimize workflows, and prevent future incidents. Collaborating closely with various teams, you will develop insights and implement solutions to improve system performance, ensuring reliable and efficient data flow critical to safety operations Roles & Responsibilities: Monitor, solve, and resolve issues related to adverse event data processing across multiple systems. Conduct detailed investigations into system disruptions, data anomalies, or processing delays and implement corrective and preventive measures. Work closely with internal teams, external vendors, and business partners to address dependencies and resolve bottlenecks for critical issues Design and maintain dashboards, reports, and analytics to monitor system performance and identify trends or areas of improvements. Present findings and recommendations to leadership, ensuring data-driven decision-making and clear transparency into system operations. Identify inefficiencies and propose data-driven solutions to optimize and enhance reliability. Collaborate on the development of test plans, scenarios to ensure robust validation of system updates, patches and new features Perform regression testing to verify the changes do not negatively impact existing system functionality Support the creating and implementation of automated testing frameworks to improve efficiency and consistency Support compliance with Key Control Indicators (KCI) and chips in to overall process governance What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: About the role Role Description: As a Sr Associate IS Analyst, you will join a collaborative team implementing and supporting the next generation of safety platforms and supporting technologies. In this role, you will analyze and resolve issues with adverse event data and file transmissions across integrated systems, leveraging data analytics to identify trends, optimize workflows, and prevent future incidents. Collaborating closely with various teams, you will develop insights and implement solutions to improve system performance, ensuring reliable and efficient data flow critical to safety operations Roles & Responsibilities: Monitor, solve, and resolve issues related to adverse event data processing across multiple systems. Conduct detailed investigations into system disruptions, data anomalies, or processing delays and implement corrective and preventive measures. Work closely with internal teams, external vendors, and business partners to address dependencies and resolve bottlenecks for critical issues Design and maintain dashboards, reports, and analytics to monitor system performance and identify trends or areas of improvements. Present findings and recommendations to leadership, ensuring data-driven decision-making and clear transparency into system operations. Identify inefficiencies and propose data-driven solutions to optimize and enhance reliability. Collaborate on the development of test plans, scenarios to ensure robust validation of system updates, patches and new features Perform regression testing to verify the changes do not negatively impact existing system functionality Support the creating and implementation of automated testing frameworks to improve efficiency and consistency Support compliance with Key Control Indicators (KCI) and chips in to overall process governance Basic Qualifications and Experience: Masters degree and 1 to 3 years of experience in Computer Science, IT or related field OR Bachelors degree and 3 to 5 years of experience in Computer Science, IT or related field OR Diploma and 7 to 9 years of experience in Computer Science, IT or related field Functional Skills: Must-Have Skills: Demonstrated expertise in monitoring, troubleshooting, and resolving data and system issues. Proficiency in data analytics, with experience in dashboarding and reporting tools such as Tableau or Power BI. Familiarity with database technologies and querying tools, including SQL (Oracle SQL, PL/SQL preferred). Understanding of API integrations and middleware platforms (e.g., MuleSoft). Experience with testing methodologies, tools, and automation practices. Experienced in Agile methodology Good-to-Have Skills: Experience with API integrations such as MuleSoft Solid understanding of using one or more general programming languages, including but not limited to: Java or Python Experience with cloud-based technologies and modern data architectures. Outstanding written and verbal communication skills, and ability to explain technical concepts to non-technical clients Sharp learning agility, problem solving and analytical thinking Experienced in GxP systems and implementing GxP projects Extensive expertise in SDLC, including requirements, design, testing, data analysis, change control Experience with Signal platforms is a plus Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Excellent analytical and troubleshooting skills Excellent leadership and strategic thinking abilities Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Ability to deal with ambiguity and think on their feet Shift Information: This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements.

In this vital role you will join a collaborative team implementing and supporting the next generation of safety platforms and supporting technologies. In this role, you will analyze and resolve issues with adverse event data and file transmissions across integrated systems, leveraging data analytics to identify trends, optimize workflows, and prevent future incidents. Collaborating closely with various teams, you will develop insights and implement solutions to improve system performance, ensuring reliable and efficient data flow critical to safety operations Roles & Responsibilities: Monitor, solve, and resolve issues related to adverse event data processing across multiple systems. Conduct detailed investigations into system disruptions, data anomalies, or processing delays and implement corrective and preventive measures. Work closely with internal teams, external vendors, and business partners to address dependencies and resolve bottlenecks for critical issues Design and maintain dashboards, reports, and analytics to monitor system performance and identify trends or areas of improvements. Present findings and recommendations to leadership, ensuring data-driven decision-making and clear transparency into system operations. Identify inefficiencies and propose data-driven solutions to optimize and enhance reliability. Collaborate on the development of test plans, scenarios to ensure robust validation of system updates, patches and new features Perform regression testing to verify the changes do not negatively impact existing system functionality Support the creating and implementation of automated testing frameworks to improve efficiency and consistency Support compliance with Key Control Indicators (KCI) and chips into overall process governance What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications and Experience: Masters degree and 1 to 3 years of experience in Computer Science, IT or related field OR Bachelors degree and 3 to 5 years of experience in Computer Science, IT or related field OR Diploma and 7 to 9 years of experience in Computer Science, IT or related field Functional Skills: Must-Have Skills: Demonstrated expertise in monitoring, troubleshooting, and resolving data and system issues. Proficiency in data analytics, with experience in dashboarding and reporting tools such as Tableau or Power BI. Familiarity with database technologies and querying tools, including SQL (Oracle SQL, PL/SQL preferred). Understanding of API integrations and middleware platforms (e.g., MuleSoft). Experience with testing methodologies, tools, and automation practices. Experienced in Agile methodology Good-to-Have Skills: Experience with API integrations such as MuleSoft Solid understanding of using one or more general programming languages, including but not limited to: Java or Python Experience with cloud-based technologies and modern data architectures. Outstanding written and verbal communication skills, and ability to explain technical concepts to non-technical clients Sharp learning agility, problem solving and analytical thinking Experienced in GxP systems and implementing GxP projects Extensive expertise in SDLC, including requirements, design, testing, data analysis, change control Experience with Signal platforms is a plus Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Excellent analytical and troubleshooting skills Excellent leadership and strategic thinking abilities Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Ability to deal with ambiguity and think on their feet Shift Information: This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements.

Reporting Structure Reports to Manager Key Roles/Responsibilities End-to-end case management, including case receipt, facilitation of case follow-up, case download from regulatory authority websites, database entry, peer review and submission to applicable regulatory authorities within stipulated timelines. Mailbox management and tracking of incoming Individual case safety reports (ICSRs). Reconciliation of ICSRs. Enter and/ or submit cases to applicable regulatory authority safety databases. Perform and monitor literature for company molecules. Maintain and update safety logs and safety files. Prepare and share compliance data with QPPV. Provide data for compliance representation/monthly information system. Assist in responding to queries and requests related to safety of products and Pharmacovigilance system from regulatory authorities. Prepare for internal or external audits and inspections. Coordination with different stakeholders for data request etc. for fulfilment of Pharmacovigilance responsibilities. Essential Qualification Bachelors/ Masters degree in Pharmacy Competencies Good communication and interpersonal skills, both written and verbal Ability to manage multiple concurrent tasks Proven ability to meet strict deadlines Ability to work independently and in a team environment Competent in use of desktop applications: Microsoft word, excel and PowerPoint

What you will do In this vital role you will join a collaborative team implementing and supporting the next generation of safety platforms and supporting technologies. In this role, you will analyze and resolve issues with adverse event data and file transmissions across integrated systems, leveraging data analytics to identify trends, optimize workflows, and prevent future incidents. Collaborating closely with various teams, you will develop insights and implement solutions to improve system performance, ensuring reliable and efficient data flow critical to safety operations Roles & Responsibilities: Monitor, solve, and resolve issues related to adverse event data processing across multiple systems. Conduct detailed investigations into system disruptions, data anomalies, or processing delays and implement corrective and preventive measures. Work closely with internal teams, external vendors, and business partners to address dependencies and resolve bottlenecks for critical issues Design and maintain dashboards, reports, and analytics to monitor system performance and identify trends or areas of improvements. Present findings and recommendations to leadership, ensuring data-driven decision-making and clear transparency into system operations. Identify inefficiencies and propose data-driven solutions to optimize and enhance reliability. Collaborate on the development of test plans, scenarios to ensure robust validation of system updates, patches and new features Perform regression testing to verify the changes do not negatively impact existing system functionality Support the creating and implementation of automated testing frameworks to improve efficiency and consistency Support compliance with Key Control Indicators (KCI) and chips in to overall process governance What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications and Experience: Masters degree and 1 to 3 years of experience in Computer Science, IT or related field OR Bachelors degree and 3 to 5 years of experience in Computer Science, IT or related field OR Diploma and 7 to 9 years of experience in Computer Science, IT or related field Functional Skills: Must-Have Skills: Demonstrated expertise in monitoring, troubleshooting, and resolving data and system issues. Proficiency in data analytics, with experience in dashboarding and reporting tools such as Tableau or Power BI. Familiarity with database technologies and querying tools, including SQL (Oracle SQL, PL/SQL preferred). Understanding of API integrations and middleware platforms (e.g., MuleSoft). Experience with testing methodologies, tools, and automation practices. Experienced in Agile methodology Good-to-Have Skills: Experience with API integrations such as MuleSoft Solid understanding of using one or more general programming languages, including but not limited to: Java or Python Experience with cloud-based technologies and modern data architectures. Outstanding written and verbal communication skills, and ability to explain technical concepts to non-technical clients Sharp learning agility, problem solving and analytical thinking Experienced in GxP systems and implementing GxP projects Extensive expertise in SDLC, including requirements, design, testing, data analysis, change control Experience with Signal platforms is a plus Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Excellent analytical and troubleshooting skills Excellent leadership and strategic thinking abilities Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Ability to deal with ambiguity and think on their feet Shift Information: This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements.