The primary location for the job is Titusville, NJ. Other job locations include Raritan, NJ/Horsham, PA/High Wycombe, UK/Allschwil, Switzerland.

The position will be responsible for identifying issues related to the Global Safety System configurations and bringing the business requirements to practical use within Aris Safety System.

In addition to existing systems supported by PV Systems, this position will manage Business Ownership, Technical Support, Audit/Inspection support for additional systems coming under the PV Systems team support including Safety Portal.

This position is responsible for the business interface between Global Medical Safety (GMS) and Information Technology (IT) for the on-going operational maintenance and operational planning of the Pharmacovigilance (PV) Systems. This includes PV Systems Business Ownership, day-to-day operational oversight, ongoing oversight and management of the data within the PV systems. The position will be the lead POC for Audit and Inspections as the PV Systems Technical SME.

Key Responsibilities

Organizational Leadership

• Act as the business facing representative for all Health Authority interactions during audits and inspections to speak on behalf of GMSO for all safety system related topics.
• Ability to work with business users trouble shooting system issues by both understanding PV business processes and being able to interact with technical teams through a fundamental understanding of relational databases.
• Create a successful team within that will work seamlessly with IT and vendors of each application to improve technical quality within the safety system suite of applications and reduce quality investigations.
• Business Ownership applications within the safety system suite of applications as well as new systems moving into PV Systems support.
• Accountability for the overall requirements for the release for each application and verification of impact assessments.
• Apply the appropriate technologies and ensure that the business has the solutions they need, when they need them, and in the media best suited to meet their requirements.

Operational Accountability

• Partner with team members to ensure the operational performance of PV Systems meet global business needs
• Develop and manage PV systems performance metrics, identifying trends and solutions for improvement with escalation as appropriate
• Manage: PV systems data standards, the integrity of the data within the safety database, database transfers into the safety database and operational projects impacting the safety systems and associated processes
• Maintain an inventory of all PV systems aligned with the Pharmacovigilance Systems Master File
• Communicate PV system releases/ upgrades and compliance and performance metrics to the appropriate groups
• Ensure the PV systems are GxP/GMP compliant with the latest industry regulations and standards
• Assess emerging global regulations with regard to impact on PV systems data integrity and standards and recommend remedial approaches.
• Proactively seek innovative solutions that could enhance compliance, efficiency and quality in PV processes, PV systems as well as upstream and downstream systems.

Decision-making and problem-solving

• Work closely with the PV Systems Project Team related to compliance and quality issues as they relate to audits and inspections, with PV Systems Operations Team in partnership with requirements and releases to the safety suite of applications, IT and business representatives
• Ensure the PV Systems meet global business needs and are compliant with regulatory compliance and vendors in the management of user support of all applications.

Qualifications

• A minimum of a bachelor’s degree is needed
• In-depth knowledge of emerging global PV regulations and assessment on the impact on current processes, systems and the data within the systems
• Investigation in and implementation of innovative solutions that provide enhanced compliance, efficiency and quality to PV processes, PV Systems and interfaces
• 8+ years of relevant experience working in Pharmacovigilance systems
• Demonstrated experience in writing PL/SQL procedures and functions
• Demonstrable experience leading teams of employees and/or contractors, including goal setting and career development
• Strong facilitation, collaboration & influencing skills; ability to form relationships, empower and collaborate at all levels in the organization and interact optimally across the regional and global organization

Preferred

• Strong understanding of SDLC methodologies including agile development

Other

• Up to 10% travel

The anticipated base pay range for this position is $113,000 to $195,500

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The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link - https://www.careers.jnj.com/employee-benefits

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com