Easter Seals Jobs

General Description:

This role will support the GPS Safety Operations to enable process efficiency, quality and compliance. This role is responsible for supporting the oversight of ICSR data quality and compliance with global PV legislation. This role is additionally responsible for supporting analysis of processes across GPS Safety Operations, deriving actionable insights, and supporting the implementation of improvement plans.

Further, this role collaborates with GPS ICSR Management and GPS Quality Operations teams in order to ensure appropriate documentation is completed in the context of ICSR data quality, ICSR submissions compliance and ad hoc identification of potential automations or other systems enhancements to increase bandwidth and relieve cognitive load from associated teams.

Essential Functions of the Job:

Process Excellence Support

• Support identification and monitoring of GPS Key Performance Metrics & Key Compliance Metrics

• Support collaboration & business requirements gathering for Safety Operations Technology & Process Improvement Projects

• Enable monitoring of performance metrics in order to ensure oversight of safety operations processes

• Support design and oversight of ICSR forecasting strategy and associated tools

• Support process evaluation, design, mapping & opportunity identification within Safety Operations

• Serve as designated point of contact for assigned processes/functions within Safety Operations & ICSR Regional Hub Model

• Support / coordinate implementation of new or updated procedures/processes, including CAPA actions, as required

• Provide consultation, as requested, on design & delivery team initiatives under Process Excellence Business Partner model

ICSR Compliance Monitoring

• Responsible for ensuring complete late case reasons and immediate actions, in collaboration with Global ICSR Management LCI SMEs

• Support GPS Quality Management Ops to support investigations, root cause analyses & QE/CAPA creation as required

• Support monthly metrics generation & maintenance of PSMF KPI Annex(es)

• Responsible for coordination of GPS Stakeholders and Business Partners / Vendors to ensure QE/CAPAs are provided for late cases

• Responsible for storage & tracking of Business Partner and Vendor QE/CAPA documentation

• Supports Monthly Inbound Business Partner Compliance Oversight

• Responsible for reviewing inbound case volume identification of any trends

• Support investigation of inbound case volume trends

• Responsible for coordination of tracking & storage of Late ICSR Responses to BP, in collaboration with PV Alliance Management, Trials Safety Management and/or Quality Management Operations

• Support Impact Assessments for Reporting Rule updates to identify potential missed submissions

ICSR Retrospective Quality

• Responsible for execution of retrospective quality check process for ICSR end-to-end workflows

• Responsible for coordination with workflow SMEs on validation and alignment of the observations

• Responsible for coordination of tracking & storage of Retrospective QC errors

• Responsible for trending of Retrospective QC Observations

• Support root cause analysis and action plan implementation on quality trends and

• Responsible for ICSR Quality Oversight aggregate analysis Retro QC & Late Cases due to data corrections

Audit & Inspection Support

• Support coordination of audit / Inspection activities for Safety Ops

• Responsible for maintaining repository / index of inspection documents, including template listings

• Serve as Safety Ops SME for document QC for inspections requests

Supervisory Responsibilities:

• None expected

Education Required:

• Minimumof4yearsofexperienceindrugsafety/PV or relevant in biotech/pharma industry, 2 years with an advanced degree

• Bachelor’s degree, or above, Life sciences, registered nurse/pharmacist/PharmD, or other health care professional or the equivalentcombinationofrelevanteducationorprofessional experience

Computer Skills: Excel, Power Point, SharePoint, required. PowerBI and/or Business Objects preferred.

Other Qualifications:

• Strong interpersonal and presentation skills, including the ability to liaise with senior leaders

• Excellent oral and written communications

• Strong analytic and strategic thinking skills with attention to detail. Comfortable with analytics tools & technologies.

• Good understanding of the need for data accuracy, completeness consistency and integrity

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.