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Global Patient Safety Systems Manager

Cambridge, MA

Posted: 05/13/2019 Employment Type: Contract Job Category: Clinical: Pharmacovigilance (PV)/Drug Safety Job Number: 2342

The contract GPS Systems Manager will provide functional leadership for Pharmacovigilance (PV) Systems and data generation in the GPS organization. This role is key for maintaining an Argus database optimized to meet GPS needs regarding safety data generation and managing the Argus database remediation and associated data transformations.

This contract GPS Systems Manager will be the accountable GPS business representative for client’ s PV Systems. The incumbent will be responsible for leading and attending internal and external meetings; coordinating disaster recovery and business continuity testing; owning PV System deviations and CAPAs; lead PV System patches/upgrades; develop change control test scripts and direct and oversee test script execution; initiate, oversee, and approve configuration changes/change controls; manage CBD maintenance; lead data migration activities; generate data query outputs; develop and maintain PV System procedures.

The Argus remediation and data transformation requires understanding of PV Systems to support end-to-end GPS Operations for investigational and marketed products and an ability to collaborate within GPS and with external stakeholders. A broad understanding is also needed of best practices for remediating and managing the Argus Safety Database within GPS, assisting GPS Services and Medical Risk Management activities with systems/tools, metrics/KPIs, and analytics.

This role requires accountability and sense of urgency in managing Argus database remediation, data transformation, and data generation in a complex work environment including strong written and verbal communication skills.

RESPONSIBILITIES:

Manage activities related to GPS Systems and data generation, with external vendor(s) as appropriate, including:
  • Argus safety database configuration and data integrity monitoring and remediation
  • Database queries and line listing for aggregate and ad-hoc reports
  • Data migration activities
  • Lead and attend internal and external meetings relating to PV Systems Management
  • Coordinate disaster recovery and business continuity testing
  • Own PV System deviations and CAPAs
  • Lead PV System patches/upgrades
  • Develop change control test scripts and direct and oversee test script execution
  • Initiate, oversee, and approve configuration changes/change controls
  • Manage CBD maintenance
  • Generate data query outputs
  • Develop and maintain PV System procedures
  • Collaborate within GPS, as needed, to further refine processes and corresponding policies, guidelines, Standard Operating Procedures (SOPs) and Work Instructions (WIs) to establish an inspection-ready and efficient PV Systems function.
  • Participate in relevant cross-functional initiatives and process improvement work streams as needed, with focus on:
  • Argus safety database upgrades and data generation
  • Database change control and ongoing maintenance
  • Educate and coach GPS colleagues in PV Systems
  • Advise on best practices related to PV Systems
  • Performs other tasks as assigned per Head of GPS

QUALIFICATIONS:

 
  • Bachelor’ s degree in science with at least 5 years’ relevant US-based global PV System experience including experience working with business partners.
  • Demonstrated knowledge of Drug Safety and pharmacovigilance processes and systems with understanding of interdependencies with other functions and PV System best practices.
  • Track record of managing PV data management systems in an insourced or outsourced environment.
  • Expertise in safety reporting applications, including proficient knowledge of Oracle Argus Safety and related tools.
  • Knowledge of clinical trial operations/electronic data capture and relationship with Drug Safety.
  • Expertise in PV database extractions in a validated environment. Expertise in E2B regulatory reporting and MedDRA and WHO Drug coding.
  • Successful track record of project and data transformation in PV functions.
  • Significant knowledge of FDA, GVP, EU safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; solid knowledge of global safety regulations.
  • Track record of delivering on time and quality in a resource-conscious environment.
  • Operational agility, adaptability to changes.
  • Attention to details with focus on compliance and efficiency.
  • Team player; open minded, creative thinker. Capable of working effectively under pressure in a multi-cultural environment, with a variety of stakeholders.
  • Contribute in maintaining an effective, open and supportive environment for the discussion of Drug Safety systems and application opportunities.

Tracey Goldthwaite
Senior Vice President

Tracey has more than 20 years experience in the staffing and recruiting industry. She spearheads The Steely Group's Client Services efforts, ensuring superior customer service, communication, and ongoing support to clients and candidates alike. Additional areas of expertise include client relationship management and team building.
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