Associate Director ICSR management PV Operations

Job Purpose

The key purpose of this role is to support Pharmacovigilance Operations "PV Ops"– ICSR Management in the following activities:

• ICSR Management

• Argus Configuration for new Programs/Studies

• ICSR processing
• Case Processing Coding Conventions
• Local Operating Companies (LOC) Interactions

• Functional Vendor Oversight:

  • New Market Authorisation
  • Withdrawal of Market
  • Authorisation
  • PAC awareness

  • Clinical Trial/Program Interactions for:

  • Study/Program Set up

  • Study/ Program Maintenance
  • Study/ Program Close out

  • Argus Configuration for Submissions to destinations including

  • Regulatory authorities

  • Partners
  • Clinical Research Organisations (CROs)
  • LOCs
  • Clinical Operations/CROs

The position holder is responsible for the above elements in alignment with GSK standards and regulatory timelines whilst driving the implementation of robust processes for successful PV operations activities, including vendor oversight.

Key Responsibilities

• Contribute to all aspects of case handling activities from case receipt to expedited reporting and collaborate with stakeholders (i.e., the Safety Evaluation and Risk Management (SERM) group, local operating companies (LOCs) Application Development, Configuration and clinical operations/sciences) to ensure that documentation and processes are in place to achieve successful recording and reporting of safety data during the life cycle of a clinical trial and marketed product.
• Work across a complex matrix environment to drive high-quality delivery of case management activities that comply with internal standards and external regulatory requirements; where problems or issues are identified, facilitate investigation into root cause and create corrective/preventative actions (CAPAs)
• Escalate identified problems or issues to the appropriate Management Personnel with PV Operations
• Generate new ideas and proposals for global implementation; contribute to advancement of PV Operations methodology and processes.
• Ensures third parties/vendors develop and implement robust processes to support quality-driven organization.
• Demonstrate GSK values
• Supervise a team of up to 10 scientific staff (Global/ local) responsible for supporting ICSR Management activities.
• Manage team to ensure appropriate prioritisation and time management, in line with business needs

• Build external relationships with key stakeholders and senior leaders

• Provides project management and case processing oversight to ensures timely submission of expedite reports to Regulatory authorities, License Partners and CRO.

• Provides support and guidance to the ICSR Management Leads and team members to ensure compliance with global regulations and adherence to GSK SOPs

• Resolve issues and concerns within the ICSR Management team and escalate to ICSR Management Director, where resolution is not possible or there is impact across PV OPS

• Ensure that all ICSR Management activities are appropriately resourced and escalates any resourcing issues

• Provide workload forecasts and work with ICSR Management Director to strategically plan, in line with business goals

• Develop the team, identify training requirements and work with training team to establish required training plan for individuals as required

• Provide workload forecasts to PV Ops Directors and work with Director to strategically plan, in line with business goals

• Enhance matrix management across PV Ops, ensuring successful connections with PV Ops sub teams

Education Requirements

• Degree in life sciences or medically related field or previous experience equating to educational requirements.

Job Related Experience

• Knowledge of GSK products and business structure
• Project management experience
• Ability to map processes and author written standards
• Knowledge and experience with pharmacovigilance systems
• knowledge of GCP and GVP requirements and reporting of adverse events with a general understanding of world-wide requirements for PV
• Technical understanding of safety processes including regulatory interpretation, SOP/GUIs, Systems/data base conventions
• Direct experience working with outsourced providers

Why GSK?
Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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