Associate Director, ICSR management, PV Operations in London

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 ambitious for patients, accountable for impact, and committed to doing the right thing, ensuring we accelerate assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.

The key purpose of this role is to support Pharmacovigilance Operations “PV Ops” – ICSR Management in the following activities: ICSR management, Clinical Trial/Program Interactions, and Argus configuration for submissions to destinations (Regulatory Authorities, Partners, CROs).

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. The Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in‑office work.

Responsibilities:

• 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.
• Provide project management and case processing oversight for clinical trials and post‑marketed programs; support spontaneous case processing activities and ensure timely completion of deliverables.
• Provide 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, where resolution is not possible or there is an impact across PV Ops, escalate to the ICSR Management Director.
• Ensure that all ICSR Management activities are appropriately resourced and raise any resourcing issues.
• Provide workload forecasts and work 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 the required training plan 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 medically related field, or equivalent experience.
• 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 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 individual contributor.

Preferred Qualifications & 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 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.

GSK is a global biopharma company dedicated to positively impacting the health of 2.5 billion people by the end of the decade. We innovate in specialty medicines and vaccines, focusing on respiratory, immunology and inflammation; oncology; HIV; and infectious diseases to impact health at scale.

As an employer committed to inclusion, we encourage you to reach out if you need adjustments during the recruitment process.