United Therapeutics Global Drug Safety Vendor and Contracts Manager in Durham, North Carolina

The Job Details are as follows:

Alliance, Vendor and Quality Lead is responsible for oversight of Global Drug Safety vendors and partners compliance with respective PVAs. Role is also responsible for management of Vendor Oversight Plans (VOPs) and interface with corporate quality team with respect to audits, CAPAs & other activities.

Key Accountabilities / Responsibilities:

  • Proactively monitor vendor, distributor and any third party involved in collection, reporting, or assessing pharmacovigilance data or product complaints (hereafter referred to as ‘vendor and partners’) performance through proactive oversight including development and implementation of VOPs

  • Collaborate with Contracts & Outsourcing team at UT to engage in selection, management (via VOP) & ensuring quality and compliance against the PVA requirements

  • Develop, maintain and oversee full implementation of relevant procedural documents, templates, including but not limited to SOPs, PVA and VOP templates) related to vendor and partner selection and oversight

  • Collaborate and support GDS team for proper execution and implementation of PVAs and VOPs specifically tailored to GDS business and vendor needs

  • Collaborate & support vendor and outsourcing team with management of UT PVA template and ensure that information is complete and current with regulations or business requirements; develop/improve/implement template and tools for agreement creation and management

  • Coordinate, communicate and collaborate with internal stakeholders (including GDS functions, Legal, Outsourcing and Contracts, Regulatory, Business Alliance, Commercial, Global Medical Information and others) to ensure that applicable third-party contracts contain pharmacovigilance language and meet UT and regulatory requirements

  • Monitor and track PVA and VOP and proactively communicate status updates to stakeholders (GDS and non-GDS) as required

  • Proactive oversight of vendors and distributors through a variety of mechanisms, including but not limited to, implementation and execution of VOP, regular communications and meeting

  • Assess vendor and performance partner and, as necessary, escalate to relevant stakeholders and work on remedial actions in the event of non-compliance, inadequate performance

  • Ensure audit and inspection readiness for vendors and partners

  • Attend UT-led audit close out meetings; ensure findings are properly and efficiently addressed and closed in a timely manner

  • Accountable and responsible for specific components of the UT Pharmacovigilance System Master File (e.g. list of GDS contracts); Accountable and responsible for collecting and contributing vendor and partner related information to compliance meeting, e.g. vendor and partner deviations for late case report submissions

  • Ensure all Quality deliverables are met in compliance with UT corporate policies

  • Collaborate with GDS/GPS team & UT corporate quality team to ensure proper audit scope, internal & external audit schedule, support of PSMF & other quality initiatives including closure of CAPAs & deviation in timely manner

  • Perform vendor risk assessment in collaboration with GDS staff and other stakeholders

Minimum Requirements:

• BS degree required

  • Minimum of 5 years of experience in healthcare or life sciences industry with pharmacovigilance experience preferred

  • Paralegal experience and Legal experience of PV contract management strongly preferred

  • Relevant quality management and support experience supporting PV is preferred

  • Competent end user of Microsoft Office software suite including Word / Excel / Outlook / PowerPoint

  • Advanced and proactive communication skills; conveys ideas clearly to multiple audiences using the most appropriate communication mechanisms. Ability to negotiate and collaborate effectively with stakeholders

  • Demonstrated ability to drive projects, as well as collaborate, communicate, and negotiate with stakeholders

  • Demonstrated ability to use advanced features of basic system applications and to identify ways to address new needs

  • Working knowledge of available information sources and ability to navigate multiple channels to secure required information

  • Working legal knowledge of PV contracts and contract execution

  • Working knowledge of drug development processes and activities

  • Working knowledge of medical concepts, terms, conditions, and associated pathology

  • Basic analytical thinking; diagnoses complex situations with broad impact and exercise sound judgment in recommending solutions

  • Working knowledge of applicable global regulatory requirements

  • Detailed understanding of vendor operational processes

  • Intermediate skills in third party contracting and management processes

  • Solid understanding of audit processes, planning and readiness activities

  • Advanced medical and scientific writing; ability to convey, legal, medical and scientific concepts clearly and effectively

  • Advanced ability to work effectively across functions

  • Strategic thinking; analyzes opportunities and issues from a broad, long-term perspective

Preferred Knowledge, Skills, and Abilities:

  • Excellent written communication skills

  • Works effectively with colleagues and facilitates achievement of common goals

  • Adaptable: able to adjust to changing business requirements

  • Continuous improvement: continually reviews internal and vendor processes and performance and identifies opportunities for improvement and efficiency gains; generates creative solutions to business challenges and fosters innovation

  • Applies working knowledge of pharmacovigilance processes and requirements to complex situations

  • Problem solves and actively provides solution to issues, suggest alternative approaches to improve work practices, and commit to defined changes

United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities

United Therapeutics currently has five approved products on the market, and a long-term mission of providing an unlimited supply of transplantable organs for those who need them! Our employees can be found collaborating across the United States, Europe and Asia.

We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high level job performance, and provide state of the art facilities in which to flourish. This is what makes United Therapeutics a stimulating place to work. We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation, and achievement into success.