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View more categories | View less categories | Sector: Health and Medical | Role: Director | Contract Type: Permanent | Hours: Full Time
Site Name: UK - London - New Oxford Street, Poznan Grunwaldzka, Warsaw Rzymowskiego 53
Posted Date: Apr 24 2025
Job Purpose
Provides in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK assets or in clinical development and/or the post-marketing setting.
Ensures scientifically sound review and interpretation of data, manages safety issues, escalates safety concerns to senior management, and makes recommendations for safety risk communication and management.
Focuses on efficiency and effectiveness to meet the needs of Patients and HCPs. Supports pharmacovigilance and benefit-risk management of GSK's global assets to ensure Patient Safety worldwide.
If appointed as a manager (i.e., Team/Group Leader), is responsible for leading a team of individual contributors, including resource management, coaching, influencing, collaboration, decision-making, change management, and partnership.
Key Responsibilities
Scientific/Medical Knowledge & PV Expertise
- Leads pharmacovigilance and risk management planning, developing strategies for evaluating clinical issues.
- Leads safety components of global regulatory submissions.
- Conducts expert evaluation and analysis of literature, clinical data, and safety information.
- Demonstrates quality decision-making and problem-solving skills, considering all relevant information and context.
- Manages multiple tasks efficiently, prioritizes effectively, and meets deadlines with high-quality standards.
- Explores options to reach mutually beneficial solutions.
Cross-functional Matrix Team Leadership
- Develops and executes safety strategies for products in clinical development and post-marketing.
- Addresses product safety issues, implements risk-reduction strategies, and facilitates safety governance meetings.
- Represents GSK on cross-functional teams, leads ad hoc safety teams, and drives process improvements.
- Prepares standard updates (e.g., SOPs) to ensure policy adherence.
- Escalates safety issues appropriately and maintains communication with safety governance bodies.
- Builds strong relationships, demonstrates leadership in matrix teams, and mentors others.
Communication and Influence
- Leads presentations on safety recommendations to senior management and external stakeholders.
- Participates in safety discussions with regulatory authorities, consultants, and partners.
- Leads process improvement initiatives and contributes to strategic safety planning.
- Prepares for audits and inspections, ensuring readiness.
- Exhibits excellent communication and influencing skills internally and externally.
Qualifications
Basic Qualifications
- Primary medical qualification (MBBS or equivalent) with specialty training (CCT and fellowship or equivalent).
- Experience in a clinical setting.
- Knowledge of international pharmacovigilance requirements (e.g., ICH, GVP, CIOMS) and drug development processes.
Preferred Qualifications
- PhD/PharmD or MPH in addition to medical degree and registration/certification.
Why GSK?
GSK unites science, technology, and talent to get ahead of disease, aiming to improve global health and deliver sustainable shareholder value. We focus on vaccines, specialty, and general medicines, investing in immunology, infectious diseases, HIV, respiratory, and oncology. Our success depends on our people, fostering an inclusive environment where everyone can thrive, grow, and be themselves.