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 ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant 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.
Find out more:
Our approach to R&D
Position Summary:

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, 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.

We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK

Responsibility :

• 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 for clinical trials and post-marketed programs, supports spontaneous case processing activities; ensures timely completion of deliverables

• 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 strategic advice to the function or oversight of direct and/or indirect reports who perform PV activities).

• Mentor new staff during onboarding

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

• 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

Why you?

Basic Qualifications & Skills:

We are looking for professionals with these required skills to achieve our goals:

• Degree in life sciences or 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 (PV) 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 individual contributor.

Preferred Qualifications & Skills:

Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

• 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.

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, making sure that we focus our efforts on accelerating significant 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.

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.

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.

Inclusion at GSK:

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

Please contact our Recruitment Team at [email protected] to discuss your needs.

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