Oncology Safety & Risk Lead (SERM)

GSK; United States; Hybrid; USD 180,000 - 260,000; Full time

Job summary

GSK is seeking a Senior Pharmacovigilance leader to drive safety strategy for oncology assets in clinical development. You will lead PV activities, manage safety signals, and contribute medical input for regulatory submissions within a global matrix organization.

The role requires strong clinical judgement, scientific communication skills, and proven capability to work across geographies. This hybrid position includes on-site governance meetings and remote collaboration.

Qualifications

• Experience leading pharmacovigilance and risk management activities across clinical development lifecycles.
• Ability to interpret clinical data, literature and signals to advise benefit-risk decisions.
• Proven track record with regulatory submissions and safety documentation.

Responsibilities

• Lead pharmacovigilance and risk management for oncology assets and trials.
• Define strategies for evaluation and management of safety issues.
• Interpret data to identify safety signals and inform governance decisions.
• Provide medical input into safety components of regulatory submissions.
• Escalate safety concerns in a timely, governance-driven manner.
• Lead cross-functional teams and Safety Review Teams (SRTs) across geographies.

Skills

Pharmacovigilance

Drug safety

Medical affairs

Signal detection

Clinical development

Communication skills

Education

Medical degree, GMC registration (UK eligibility)

Postgraduate specialisation in clinical discipline or pharmaceutical medicine

Job description

GSK is seeking a Senior Pharmacovigilance leader to drive safety strategy for oncology assets in clinical development. You will lead PV activities, manage safety signals, and contribute medical input for regulatory submissions within a global matrix organization.

The role requires strong clinical judgement, scientific communication skills, and proven capability to work across geographies. This hybrid position includes on-site governance meetings and remote collaboration.