Associate Director / Senior Manager, PV (Pharmacovigilance) Operations
The key purpose of this role is to support Pharmacovigilance Operations PV Ops including ICSR Management, Clinical Trial/Program Interactions, and Argus Configuration for submissions to regulatory authorities, partners, and 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 practices; our Performance with Choice programme offers a hybrid working model to balance 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 programmes, 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 impact across PV Ops, elevate to the ICSR Management Director.
- Ensure that all ICSR Management activities are appropriately resourced and escalates 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 oversee 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 that equates to the 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, 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.
Closing Date
28 December 2025 (COB)
Equal Opportunity Employer
GSK is an Equal Opportunity Employer. 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, military service or any basis prohibited under federal, state or local law.