Associate Director overseeing ICSR Management within Pharmacovigilance Operations at GSK. Leading a team while ensuring compliance with regulations and managing external stakeholder relationships.
Responsibilities
Support Pharmacovigilance Operations “PV Ops” – ICSR Management
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
Ensure timely completion of deliverables
Provide support and guidance to the ICSR Management Leads and team members to ensure compliance with global regulations
Resolve issues and concerns within the ICSR Management team and escalate when necessary
Provide workload forecasts and work with ICSR Management Director to strategically plan
Develop the team, identify training requirements and establish required training plan
Mentor new staff during onboarding
Use influencing skills to drive best practice and innovation across PV Ops
Requirements
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
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