Director, Us - Philadelphia, United States - GSK

GSK
GSK
Verified Company
Philadelphia, United States

3 weeks ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description

Site Name:
USA - Pennsylvania - Philadelphia


Posted Date:
May


The
Director, US & Regions Intelligence Oversight, Pharmacovigilance (PV) Operations serves as the first point of contact for PV Regulatory intelligence (PVRI), issues and escalations across US & Regional PV Operations, Global Safety (183 country remit).

The role will include liaising with our partners in regulatory affairs, medical affairs and clinical operations. The incumbent is a PV exert with deep demonstrated proficiencies in worldwide pharmacovigilance regulations (e.g. US, Canada, EU, UK, Latam, Asia Pacific, Middle East and Africa) necessary to address PVRI & escalations.

Furthermore, 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.


_ Key Responsibilities_:


  • This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include _some of the following._
  • The Director, US & Regions Regulatory Intelligence Oversight, PV Operations position is directly responsible for all aspects of daytoday Regional PVRI, 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 daytoday PV operations and regions for US FDA, European Union, Emerging Markets and Greater China & Intercontinental (e.g. DHCPL, inspection responses, etc.).
  • Facilitates and maintains PVRI activities worldwide including collection, tracking, assessment and implementation worldwide.
  • Provides high level management and supervision of the company's US and Regional PVRI 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 PVRI operations both in and above country (incl. structure, PV issue and escalation remediations, HA interactions, etc.).
  • Actively develop and manage relevant Regional PVRI SOPs, working practices and guidance to support the Regional delivery as required and incompliance with US and Worldwide regulations.
  • Produce and deliver performance metrics required for oversight of US & Regions PVRI 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) lifecycle management, Veeva Vaults, etc.) to ensure oversight of US & Regions.
  • Leads and orchestrates crossfunctional 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 PVRI management, quality & compliance campaigns and plans to structure insync 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 PVRI system.
  • Escalate noncompliance 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 crossfunctional 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.

_ Why you?_

Basic Qualifications:


  • We are looking for professionals with these required skills to achieve our goals:_
  • Advanced degree (MS, PhD, PharmD.) in pharmacy, toxicology, life sciences, or equivalent
  • 10+ years Pharmacovigilance experience
  • Recent work experience in Veeva Vault
  • Experience working with regulatory agencies and knowledge of ICH and GCP regulations
  • Experience leading clinical and global programs
  • Experience in project management and leading multinational, cross functional teams across a broad spectrum pf PV or related programs, projects or other activities
  • Experience in people leadership, employee engagement, development and r
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