Associate Director, ICSR management, PV Operations

Business Introduction

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting edge technology to transform people's lives. GSK fosters a culture of ambition for patients, accountability for impact, and a commitment to doing the right thing, ensuring we focus our efforts on accelerating high probability assets that meet patients' needs.

Position Summary

The key purpose of this role is to support Pharmacovigilance Operations (PV Ops) ICSR Management in activities such as ICSR management, clinical trial/program interactions, and Argus configuration for submissions to regulatory authorities, partners, and CROs.

We offer a competitive salary, an annual performance based bonus, healthcare and well being programmes, a pension plan, and a shares and savings programme. Our hybrid working model supports a balance between remote and in office work.

Responsibilities

• Supervise a team of up to 10 scientific staff (global and local) responsible for supporting ICSR management activities.
• Manage the team to ensure appropriate prioritisation and time management in line with business needs.
• Build external relationships with key stakeholders and senior leaders.
• Provide project management and case processing oversight clinical trials and post market programmes, support spontaneous case processing activities, and ensure timely completion of deliverables.
• Guide 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; when resolution is not possible or there is impact across PV Ops, elevate to ICSR management director.
• Ensure that all ICSR management activities are appropriately resourced and raise any resourcing issues.
• Provide workload forecasts and collaborate with the ICSR management director to strategically plan in line with business goals.
• Develop the team, identify training requirements, and work with the training team to establish required training plans for individuals.
• Provide strategic advice to the function or oversight of direct and/or indirect reports who perform PV activities.
• Mentor new staff during onboarding.
• Use influencing skills to drive best practice and innovation across PV Ops.
• Enhance matrix management across PV Ops, ensuring successful connections with PV Ops sub teams.

Basic Qualifications & Skills

• Degree in life sciences or a medically related field, or previous experience equating to educational requirements.
• End to end case processing knowledge, from intake to submissions, and experience managing teams performing these processes.
• In depth knowledge of pharmacovigilance concepts and project management within PV, including regulatory requirements, documentation, process design, implementation, and writing standards.
• Experience in clinical trials from a PV perspective (not just general clinical trial roles like CRA), or post marketing PV; candidates with only one area may be considered for a suitable team fit.
• Functional oversight and team management experience, ideally at associate director or manager level, or past experience managing teams even if currently an>; Skills
  • Experience with inspections and audits in PV.
  • Technological experience, such as working on automation or AI projects, rolling out new technology, or serving as an SME in such initiatives.
  • Ability and willingness to adapt to new technology and automation trends in PV.
  What you will bring
  • Sound medical judgement and a patient focused safety perspective.
  • Commitment to high quality, regulatory compliance, and continuous improvement.
  • Collaborative approach and ability to influence across teams.
  • Willingness to coach others and support development of peers.
  • Openness to learning and adapting in a changing environment.
  Why GSK?

  Unite science, technology, and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to advance patient health through innovative medicines and vaccines across respiratory, immunology, oncology, HIV, and infectious diseases.

  Inclusion at GSK

  As an employer committed to inclusion, we encourage you to reach out if you need any adjustments process. Contact our recruitment team at to discuss your needs.