Shire Safety System Support Lead in Cambridge, Massachusetts
Primary responsibility is to support the functioning and effective use of the Shire Global Safety System (SGSS) as it relates to configuration set-up and retrieval of safety information. Assist Safety System Support Head to manage business aspects of the Shire Global Safety System(s), including maintenance, change requests, documentation, and system security. Operate as the primary system administrator for SGSS, leading all configuration and validation activities involving SGSS console updates and system upgrades. Serve as the SGSS configuration subject matter expert to ensure complete and accurate data input and retrieval of safety information from SGSS.
Job Function and Description
Operate as Primary System Administrator for Shire Global Safety system (SGSS)
Assist Safety System Support Head with business aspects of SGSS by interfacing with IT and QA to manage system operation and compliance
Coordinate and implement all Argus configuration revisions as required, including product license configurations, License Partner and Regulatory Agency reporting rule set-up, and Study record creation
Ensure Reporting Algorithms are accurate according to product and country requirements
Assist GDS functional teams with reporting and data mining activities of the SGSS including compilation of metrics data, the use of Advanced Conditions, setting up of standard queries and the use of reporting tools
Generate required listings and tables from SGSS
Assist with non-standard database querying and reporting solutions as directed by Head Safety System Support, including author and execution of required dataset output using non-standard reporting solutions
Act as validation lead in system migrations and upgrades
Contribute to the validation, implementation and maintenance of IT computer systems to maximize the effective use of SGSS
Ensure on-time electronic submission of expedited reports to Regulatory Authorities and Business Partners globally
Delegate appropriately to staff electronic reporting tasks including error-checking of outbound ICSR messages and ensuring Acknowledgment records are processed appropriately
Provide day-to-day pharmacovigilance system support to ensure continuity of electronic and paper-based reporting to regulators or from/to Shire affiliates
- Identify, collate, and respond to issues raised concerning the Shire Global Safety System(s)
- Contribute to the production and/or maintenance and training of Pharmacovigilance-specific Standard Operating Procedures, Working Practice Documents and Guidelines referring to the use of Global Safety Systems
Education and Experience Requirements
Minimum of a Bachelor’s of Science Degree
8-10 years of previous experience working in Pharmacovigilance or equivalent to include safety reporting to clinical trials, post marketing surveillance and reporting to Regulatory Authorities worldwide.
8- 10 years experience of working with Safety Systems including use of Administrator tools
8 -10 years of hands-on experience with Systems Validation projects including User Acceptance Testing (UAT) and Performance Qualification (PQ) script authoring
5 -7 years of working knowledge and hands-on experience with E2B report
5 -7 years of experience with MedDRA design and practices
Working knowledge of Excel business solutions including Pivot Tables
Working knowledge of Microsoft Office Suite (Word, Access and PowerPoint)
Knowledge of Structured Query Language (SQL)
Previous experience in Pharmacovigilance
Key Skills, Abilities, and Competencies
Requires strong attention to detail in creating database queries and Argus configuration methodology
Ability to work independently, take initiative and complete tasks to deadlines.
Requires good communication and organisational skills.
Must be able to work in a fast-paced, deadline-driven environment with the ability to simultaneously manage multiple competing tasks and demands.
Complexity and Problem Solving
It is vital that safety reports are submitted to the Health Authorities in a timely manner to ensure regulatory compliance is maintained. Decisions need to be made on a daily basis to monitor and determine the priority of creating and reporting such safety reports.
It is expected that the incumbent will adapt quickly to changing business, system and Regulatory Authority needs, and be largely autonomous, while working according to direction from the PV System Operations Lead on the implementation of major decisions.
The global safety database is a core part of the business in globally. Ongoing communication with the Safety System Support Head and Specialists / Sr Specialists is a vital part of problem solving. The impact of potential problems may be highly complex and involve active communication in a cross-functional setting to manage various aspects of determining the optimal solution.
Will regularly interact with Pharmacovigilance, IT and Regulatory staff on system-related issues. May also need to interact with contract research organisations and co-marketing companies.
Interactions with Regulatory Agencies are required on submission of expedited and aggregate reports, variations, at the time of inspection and when working on interfaces with agency-based systems (e.g. for ICH-compliant Individual Case Safety Reports). Accountable to Head Safety System Support, Head Global Drug Safety Operations, and the EU Qualified Person for Pharmacovigilance for products marketed in the EEA.
Other Job Requirements
Domestic and international travel will be required (<20%).
May be required to travel domestically and internationally to other Shire sites and external meetings.
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Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.