Drug Safety Analyst

Job description

Grifols is a global healthcare company whose mission is to improve the health and well being of people. Our three divisions –Bioscience, Diagnostic and Hospital–develop, produce and market our innovative products and services to medical professionals in more than 100 countries.

We are committed to fostering an environment that creates continuous learning opportunities and encourages professional development and growth. As a company devoted to improving the health and well-being of people, we are looking for talented professionals worldwide. Make a difference and join us in this challenging and rewarding enterprise.

Title: Drug Safety Analyst

Job Description:

Interact with the Drug Safety/Pharmacovigilance (PV) users as needed to understand the business process and scientific requirements to design and implement current and future Drug Safety applications to accomplish PV objectives. Collaborate with the database implementing vendor to perform pharmacovigilance gap analysis, define to-be processes in Argus Safety database, and work with business users to optimize future processes in Argus. Support configuration workshops and conduct interviews with business users, as required. Work closely with IT Team, Validation team and vendors to support implementation and resolve product issues and perform UAT tests as needed. Prepare documents such as status reports, data flow diagrams, SOPs, Work Instructions, impact assessments, training materials and user manuals. Design, develop project deliverables (User requirement specifications, Argus Company product dictionary, Clinical Studies Mapping, AERS to Argus Product Mapping, codelist mapping, field to field mapping, PBRER and DSUR reports, aggregate reports, Compliance reports, write SQL, PL/SQL queries in Argus Safety data model for data extraction, advance conditions, ad hoc queries and custom reports using Business Objects on Argus Insight data model) and ensure effective implementation of tasks in a high quality manner. Provide training to  business users by facilitating hands-on sessions and provide post-transition support. Use Argus technical expertise to understand, troubleshoot and fix problems to restore service. Identify root cause and make necessary configuration changes. Query drug safety database, generate case listings to be used for periodic and ad hoc reporting of ICSRs and extract data for auditors, partners, regulatory authorities. Apply knowledge of ICSR reporting requirements to regulatory agencies, submission process of ICSRs to regulatory agencies. Understand per country reporting requirements of ICSRs and establish submission process. Subject matter expert to review and update technical solutions/specifications (configuration specification document (CSD/CBD), data migration strategy, product migration strategy, design of periodic reports (PBRER/DSUR) in Argus Safety and Argus Insight data model for BO, custom reports developed in Business Objects) provided by the vendor company and ensure technical components provided are fit for business needs. Collaborate with Validation team in the development, execution, approval and monitoring of the Qualification (Test Plan, Test Scenarios, IQ, PQ scripts and protocols, results and reports) deliverables for Argus Safety and Argus Insight. Analyze the regulatory requirements for E2B R2, E2B R3 (ICH standard for ICSR electronic transmission) and IDMP (Identification of Medicinal Product), which impact drug safety database to identify the gaps in the database and build a plan for IDMP and E2B R3 Implementation. Convert the requirements into technical specifications and implement the changes in drug safety database to achieve compliance. Use Axway Interchange to transmit ICSR E2B R2 XML Files to test gateway setup with regulatory agencies. Troubleshoot and fix the issues encountered in the interchange process. Validate Argus Safety, Argus Insight, data migration, periodic reports, reporting rules, custom reports and SAP interface developed using the scripts developed. Test MedDRA Upgrades and design / update algorithmic SMQs in drug safety database. Create and deliver Standardized/consistent/accurate data retrievals using SQL from the safety database (Argus Safety Data model), Compliance reports, routine monthly metrics reports and/or ad hoc queries using Business Objects (Argus Insight Data Model), as requested by the Global Pharmacovigilance management team.

Requirements:

Candidate must have a Master’s degree in Computer Engineering or Electrical Engineering and minimum of 2 years IT business/technical analysis and data migration experience in Drug Safety/ Pharmacovigilance (PV) with knowledge of business processes and regulations. Must have experience in: the design and implementation of applications to sustain PV objectives, including Argus Safety database, MedDRA, SMQs etc; programming, validation, and generation of reports (Periodic, Adhoc, Compliance and aggregate) for data analysis using Argus Safety, Business Objects or Cognos; configuring and troubleshooting Oracle Argus Safety Suite (Including E2B and XML); interpreting and implementing regulatory changes as they impact pharmacovigilance technology and compliance; Argus data model (both Safety and Insight) to write SQL, PL/SQL queries for data extraction.

 

Location: NORTH AMERICA : USA : NC-Clayton 

Learn more about Grifols

Grifols is a global healthcare company whose mission is to improve the health and well being of people. Our three divisions –Bioscience, Diagnostic and Hospital–develop, produce and market our innovative products and services to medical professionals in more than 100 countries.

We are committed to fostering an environment that creates continuous learning opportunities and encourages professional development and growth. As a company devoted to improving the health and well-being of people, we are looking for talented professionals worldwide. Make a difference and join us in this challenging and rewarding enterprise.

Title: Drug Safety Analyst

Job Description:

Interact with the Drug Safety/Pharmacovigilance (PV) users as needed to understand the business process and scientific requirements to design and implement current and future Drug Safety applications to accomplish PV objectives. Collaborate with the database implementing vendor to perform pharmacovigilance gap analysis, define to-be processes in Argus Safety database, and work with business users to optimize future processes in Argus. Support configuration workshops and conduct interviews with business users, as required. Work closely with IT Team, Validation team and vendors to support implementation and resolve product issues and perform UAT tests as needed. Prepare documents such as status reports, data flow diagrams, SOPs, Work Instructions, impact assessments, training materials and user manuals. Design, develop project deliverables (User requirement specifications, Argus Company product dictionary, Clinical Studies Mapping, AERS to Argus Product Mapping, codelist mapping, field to field mapping, PBRER and DSUR reports, aggregate reports, Compliance reports, write SQL, PL/SQL queries in Argus Safety data model for data extraction, advance conditions, ad hoc queries and custom reports using Business Objects on Argus Insight data model) and ensure effective implementation of tasks in a high quality manner. Provide training to  business users by facilitating hands-on sessions and provide post-transition support. Use Argus technical expertise to understand, troubleshoot and fix problems to restore service. Identify root cause and make necessary configuration changes. Query drug safety database, generate case listings to be used for periodic and ad hoc reporting of ICSRs and extract data for auditors, partners, regulatory authorities. Apply knowledge of ICSR reporting requirements to regulatory agencies, submission process of ICSRs to regulatory agencies. Understand per country reporting requirements of ICSRs and establish submission process. Subject matter expert to review and update technical solutions/specifications (configuration specification document (CSD/CBD), data migration strategy, product migration strategy, design of periodic reports (PBRER/DSUR) in Argus Safety and Argus Insight data model for BO, custom reports developed in Business Objects) provided by the vendor company and ensure technical components provided are fit for business needs. Collaborate with Validation team in the development, execution, approval and monitoring of the Qualification (Test Plan, Test Scenarios, IQ, PQ scripts and protocols, results and reports) deliverables for Argus Safety and Argus Insight. Analyze the regulatory requirements for E2B R2, E2B R3 (ICH standard for ICSR electronic transmission) and IDMP (Identification of Medicinal Product), which impact drug safety database to identify the gaps in the database and build a plan for IDMP and E2B R3 Implementation. Convert the requirements into technical specifications and implement the changes in drug safety database to achieve compliance. Use Axway Interchange to transmit ICSR E2B R2 XML Files to test gateway setup with regulatory agencies. Troubleshoot and fix the issues encountered in the interchange process. Validate Argus Safety, Argus Insight, data migration, periodic reports, reporting rules, custom reports and SAP interface developed using the scripts developed. Test MedDRA Upgrades and design / update algorithmic SMQs in drug safety database. Create and deliver Standardized/consistent/accurate data retrievals using SQL from the safety database (Argus Safety Data model), Compliance reports, routine monthly metrics reports and/or ad hoc queries using Business Objects (Argus Insight Data Model), as requested by the Global Pharmacovigilance management team.

Requirements:

Candidate must have a Master’s degree in Computer Engineering or Electrical Engineering and minimum of 2 years IT business/technical analysis and data migration experience in Drug Safety/ Pharmacovigilance (PV) with knowledge of business processes and regulations. Must have experience in: the design and implementation of applications to sustain PV objectives, including Argus Safety database, MedDRA, SMQs etc; programming, validation, and generation of reports (Periodic, Adhoc, Compliance and aggregate) for data analysis using Argus Safety, Business Objects or Cognos; configuring and troubleshooting Oracle Argus Safety Suite (Including E2B and XML); interpreting and implementing regulatory changes as they impact pharmacovigilance technology and compliance; Argus data model (both Safety and Insight) to write SQL, PL/SQL queries for data extraction.

 

Location: NORTH AMERICA : USA : NC-Clayton 

Learn more about Grifols