Associate Director/Director, Drug Safety Operations

Associate Director/Senior Manager, PV (Pharmacovigilance) Operations
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 offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.
our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.
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
Provides project management and case processing oversight for clinical trials and post-marketed programs, supports spontaneous case processing activities; 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
Degree in life sciences or medically related field or previous experience equating to educational requirements.
In-depth knowledge of pharmacovigilance (PV) concepts and project management within PV, including regulatory requirements, documentation, process design, implementation, and writing standards.
Functional oversight and team management experience, ideally at associate director or manager level, or past experience managing teams even if currently an individual contributor.
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.
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. 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.
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. 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.
This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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