Head US & Regions Issue Compliance Oversight, PV Operations
This role can be home based residing on the US eastern coast, Durham NC, or in one of our Philadelphia PA locations.
The Head of US & Regions Issue Compliance Oversight, PV Operations serves as the first point of contact for all safety related issues and escalations across US & Regional PV Operations, Global Safety (183 country remit). The incumbent is a PV expert with deep demonstrated proficiencies in worldwide pharmacovigilance regulations (e.g. US, EU, Emerging Markets, and Greater China & Intercontinental) necessary to address escalations.
This position serves as a strategic partner managing issue, quality and regulatory compliance related to Good Pharmacovigilance Practices (GVP) and holds a regional PV leadership role as it relates to ensuring PV quality of process, tools and technologies in sync with regulatory demand and dynamics.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following.
The Head US & Regions Issue & Compliance Oversight, PV Operations position is directly responsible for all aspects of day to day Regional PV issue management, communication and escalation, CAPA resolution, documentation and timely communication to stakeholders and health authorities as appropriate.
Act as Regional gatekeeper and reviewer of all outbound correspondence to health authorities worldwide related to day-to-day PV operations and regions for US FDA, European Union, Emerging Markets and Greater China & Intercontinental (e.g. DHCPL, inspection responses, etc.).
Facilitates and maintains a risk-based and scientific-based quality and compliance approach to PV Operations and Regions to support GSK’s world-class PV organization.
Provides high level management and supervision of the company’s US and Regional pharmacovigilance processes, identifies process gaps and facilitates resolutions congruent with industry best practices.
Advises senior management on global safety related strategy and pathways to achieve best in class PV operations both in and above country (incl. structure, PV issue and escalation remediations, HA interactions, etc.).
Actively develop and manage relevant Regional PV SOPs, working practices and guidance to support the Regional delivery of the single-vendor PV model as required and incompliance with US and Worldwide regulations.
Produce and deliver performance metrics required for oversight of US & Regions drawing on deep understanding of global safety regulations and health authority expectations.
Leverages data and technology to orchestrate safety innovations that deliver against set objectives, defined budgets and timelines (e.g. regional workflow management system(s) life-cycle management) to ensure oversight of US & Regions.
Leads and orchestrates cross-functional US & Regional safety meetings and activities to deliver harmonized issue management for PV
Drives centralized/local innovations with ability to scale up throughout the Regional PV Ops remit while ensuring the assigned work complies with GSK established practices, policies and processes and any regulatory or other requirements.
Champions safety management, quality & compliance campaigns and plans to structure in-sync global harmonization of operative processes and procedures.
Partner as Deputy to Head of US & Regions PV Operations, with senior local/regional and global roles outside the PV organization and membership at Regional Lead team forums and governance boards to develop strategies to reduce risk to the PV system.
Escalate non-compliance in the region to Local Risk Board, Head of Regions, Head of Pharmacovigilance (PV Operations), EEA QPPV and Head of Safety as appropriate.
Plays a leadership role on PV and regional cross-functional teams, including leadership on special projects, participation in continuous improvement and optimization initiatives and PV Ops functional area support in PV audits and inspections.
Orchestrates tactful fiscal approaches to PV Regions approach to operations, corporate strategy and commercial business necessary to drive innovation while balancing the dynamic regulatory environment.
We are looking for professionals with these required skills to achieve our goals:
Advanced degree (MS, PhD, PharmD.) in pharmacy, toxicology, or life sciences
10+ years relevant PV experience working in the Pharmaceutical industry
5 + years' experience with regulatory agencies working with ICH and GCP regulations
Prior experience leading PV in a large global, matrix environment.
FDA inspection and Inspection management experience
Experience in project management
Experience in leading multinational, cross functional teams across a broad-spectrum pf PV activities
Domestic and International travel will be required.
If you have the following characteristics, it would be a plus:
Line management (direct reports) experience is strongly preferred.
Proven track record of effective people leadership, as evidenced through past effectiveness with employee engagement, development and retention either with direct reports or through matrix leadership responsibilities.
Strong track record of cultivating and maintaining strategic relationships and collaborations both internally and externally.
Skilled in change management, helping resolve issues, and can successfully navigate times of ambiguity.
Skilled at working effectively with cross functional teams in a large global matrix organization.
Excellent written and verbal communication skills.
High degree of problem solving and impact assessment capabilities.
Skilled at resolving non-routine issues.
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
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