Senior Pharmacovigilance Scientist - Global Safety Lead

Immunocore; Oxford; Sur place; GBP 90 000 - 150 000; Plein temps

Résumé du poste

Immunocore in the United Kingdom seeks a Senior Manager, Pharmacovigilance Scientist to lead product-level safety surveillance and risk management across the lifecycle. You will collaborate with Safety Physicians and PV Operations to drive safety strategy on cross-functional projects.

The role requires extensive experience in global PV regulations, signal detection, and expert medical writing. Strong leadership and a track record of guiding teams and vendors are essential.

Qualifications

• 12+ years of experience in biotechnology or pharmaceutical industry.
• Experience supporting safety surveillance for clinical development and/or marketed products.
• Experience with signal detection, evaluation, and benefit-risk assessment.
• Experience authoring or contributing to DSURs, PBRERs/PSURs, PADERs, RMP.
• Working knowledge of global pharmacovigilance regulations (FDA, EMA, MHRA, ICH, GVP, CIOMS).

Responsabilités

• Lead safety surveillance for assigned investigational and/or marketed products.
• Lead signal detection, evaluation, documentation, communication, and closure per Immunocore procedures and global requirements.
• Integrate safety data from trials, ICSRs, literature, and analyses.
• Lead benefit-risk assessments and communicate recommendations to Safety Management Teams.
• Escalate emerging safety issues to senior stakeholders.
• Oversee DSURs, PBRERs/PSURs, PADERs and other reports.
• Lead or review Investigator Brochures, Safety Information, and risk plans.
• Ensure safety documentation is rigorous, consistent, and compliant.
• Manage timelines and cross-functional review processes.
• Develop product-specific pharmacovigilance and risk management plans.
• Provide PV input to development and lifecycle management.
• Collaborate with Regulatory and Medical Affairs on safety messaging.
• Represent PV on program teams and governance forums.
• Coordinate external vendors and cross-functional contributors.
• Maintain inspection readiness and respond to queries and CAPA.

Connaissances

Pharmacovigilance

Signal detection

DSURs

PBRERs/PSURs

Regulatory compliance

Safety data analysis

Leadership

Cross-functional collaboration

Medical writing

Vendor management

Formation

Bachelor's degree in life sciences or related

Advanced degree (MS/PhD/PharmD) preferred

PV certification desirable

Outils

Argus

ARISg

Veeva Safety

Description du poste

Immunocore in the United Kingdom seeks a Senior Manager, Pharmacovigilance Scientist to lead product-level safety surveillance and risk management across the lifecycle. You will collaborate with Safety Physicians and PV Operations to drive safety strategy on cross-functional projects.

The role requires extensive experience in global PV regulations, signal detection, and expert medical writing. Strong leadership and a track record of guiding teams and vendors are essential.