Director PV Application Development and Reporting

Collegeville, Pennsylvania; Waltham, Massachusetts
January 06 2021
Organization Type
Are you energized by a highly visible pharmacovigilance role that optimizes safety and risk management standards on a global scale? If so, this Director, PV Application Development and Reporting role could be an ideal opportunity to explore.

The essence of the Pharmacovigilance (PV) Systems groups is to provide a channel between PV system users and IT suppliers and back again in three key areas - systems delivery, systems validation and systems support. The key systems management activities are:
  • Project Management
  • Business Analysis
  • Data Access and Analysis
  • Systems Validation
  • Systems Support and Maintenance
  • Training

They ensure that the design, maintenance and support of the PV systems and their configuration enables GSK to efficiently, timely, accurately and consistently report and analyze data from all relevant data sources, process cases, report cases to regulators and monitor the safety of our marketed products and investigational compounds.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
  • Manage a global team accountable for:
  • the design, maintenance and support of PV computer systems and associated processes
  • the design, configuration, implementation, maintenance and support of signal detection/evaluation tools
  • extraction of data and performing data analyses for end users
  • providing complex query and reporting support for end users
  • developing and implementing custom reports for end users
  • configuring and maintaining a safety data mart and reporting environment for the safety database
  • exploring new data sources and methodologies to optimize benefit-risk assessment of our products
  • Contribute to the strategic PV systems roadmap for GSK and ensure PV systems support business processes
  • Ensure GSK source systems are referenced to maintain product configuration consistency
  • Proactively identify areas which would benefit from new systems and technology by maintaining awareness of industry trends and regulatory changes worldwide in pharmacovigilance.
  • Lead delivery of innovative technology to enable proactive, quality monitoring of human safety of our products while continuously improving operational efficiency
  • Develop business cases for new technologies or changes to existing systems which have a clear return on investment
  • Contribute to a systems governance model for PV systems
  • Participate in new software/systems evaluations
  • Contribute to development and management of an operational model for front-line support for PV systems users
  • Ensure adherence to GSK's and external regulators' computer system validation guidelines for development and maintenance of PV systems
  • Represent GSK externally in order to influence the direction Pharmacovigilance is taking
  • Work with external IT suppliers to ensure their systems meet GSK's needs requiring interaction and buy-in from the industry as a whole

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • BS/BA degree required. Scientific or medically related field and experience in the pharmaceutical industry in clinical development, pharmacovigilance and information management
  • Minimum 7 years of experience in the pharmaceutical industry in clinical development, pharmacovigilance or information management

Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Thorough knowledge of database management, system analysis and design
  • Thorough knowledge of query and data analysis toolsets and of systems architecture to enable efficient data retrieval and visualization
  • Through understanding of computer system validation

Why GSK?

Our values and expectationsare at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

  • Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk
  • Managing individual and team performance.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Implementing change initiatives and leading change.
  • Sustaining energy and well-being, building resilience in teams.
  • Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
  • Developing people and building a talent pipeline.
  • Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
  • Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
  • Budgeting and forecasting, commercial and financial acumen.

*This is a job description to aide in the job posting, but does not include all job evaluation details.

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