Director, Global Pharmacovigilance / Safety Operations

Location of Role: Gaithersburg, MD, Radnor PA, Oxford, UK, Remote US

Department: Regulatory Affairs

The Director, Safety Operations is a senior pharmacovigilance operations leader accountable for the end-to-end execution, quality, and continuous improvement of global safety operations for Immunocore’s development and marketed products. The role holder is an experienced pharmacovigilance professional with deep expertise in case management, safety systems, PV compliance, and vendor oversight.

The role leads global case management, regulatory reporting, and safety operational processes across clinical and postmarketing settings, ensuring a robust, inspection ready PV system that meets GVP and other global regulatory requirements (e.g., MHRA, EMA, FDA, ICH, CIOMS). The Director oversees safety databases and related tools (including configuration, validation, and lifecycle management in partnership with IT and Safety Systems), manages external vendors/CROs, and builds a high performing Global Safety Operations team with direct line management responsibilities. The role also partners closely with Safety Physicians and cross functional stakeholders to ensure high quality safety data supports signal detection, aggregate reporting, and benefit–risk assessment throughout the product lifecycle, providing both strategic direction and hands-on operational leadership.

KEY RESPONSIBILITIES

• Lead and continuously improve global safety operations processes, including case intake, processing, and submissions, ensuring alignment with global PV regulations and company policies.

• Oversee timely and compliant case processing and regulatory reporting of Individual Case Safety Reports (ICSRs) from all sources.

• Ensure robust operational oversight of internal and external safety case management, including performance monitoring and quality metrics.

• Provide strategic leadership for the selection, configuration, validation, and life-cycle management of safety systems and tools, in partnership with IT and Safety Systems teams.

• Lead the design, implementation, and maintenance of standard operating procedures (SOPs), work instructions, and training for safety operations.

• Ensure inspection readiness and support internal audits, Health Authority inspections, and partner audits related to PV operations, coordinating responses and remediation plans.

• Collaborate with Safety Physicians and cross-functional teams to ensure high-quality data for signal detection, aggregate safety reporting, benefit–risk assessments, and Risk Management Plans (RMPs).

• Provide senior operational input into Safety Management Teams and cross-functional project teams, managing operational feasibility, timelines, and compliance risks.

• Lead operational aspects of safety data exchange agreements (SDEAs) with partners and licensees and oversee literature surveillance workflows.

• Recruit, lead, and develop a Global Safety Operations team, manage budgets and resources, and act as the primary point of contact for safety operations with internal stakeholders.

SUPERVISORY RESPONSIBILITY

This position has direct line management responsibilities for a team of global safety operations professionals with matrix oversight of additional staff or vendor teams performing PV operational activities.

COMPETENCIES

• Strong expertise in pharmacovigilance operations, including case processing, regulatory reporting, PV systems, and vendor oversight in a GVP regulated environment.

• Demonstrated leadership and people management skills, with experience building and developing teams.

• Strong analytical, organizational, and project management skills, with the ability to manage multiple priorities and deliver high quality outcomes to tight timelines.

• Excellent written and verbal communication skills, able to convey complex operational and regulatory concepts clearly to both technical and non-technical audiences.

• Proven ability to collaborate effectively across functions and regions, building strong relationships and influencing without direct authority.

• High level of integrity, discretion, and commitment to patient safety, compliance, and ethical conduct.

EXPERIENCE & KNOWLEDGE

Essential

• Extensive experience (5 years) in pharmacovigilance operations, with significant leadership in global ICSR management and regulatory reporting.

• In-depth knowledge of global PV regulations (GVP, ICH, FDA, MHRA, EMA) and proven ability to implement them operationally.

• Strong experience with safety databases and PV systems, including configuration, validation, and maintenance.

• Demonstrated ability to lead, develop, and manage a team of PV professionals and oversee PV vendors/CROs.

• Proven track record in preparing for and supporting Health Authority inspections and audits, alongside strong project management skills.

Desirable

• Advanced degree in a relevant scientific or health-related field.

• Experience with safety data exchange agreements (SDEAs) and literature surveillance.

• Demonstrated ability to drive continuous improvement, process optimization, and automation in PV operations.

• Familiarity with operational support for Risk Management Plans (RMPs) and aggregate safety reports.

• Demonstrated understanding of clinical development processes.

• Experience with global product launches and implementation/assessment of complex risk minimisation measures.

• Evidence of scientific contributions to the field (e.g., peer reviewed publications, invited presentations, guideline development, or recognised subject matter expertise in biologic safety).

EDUCATION & QUALIFICATIONS

• Bachelor's degree or equivalent in a life science, pharmacy, nursing, or a related health field.

• Relevant certifications in pharmacovigilance or drug safety are highly desirable.

US Salary Range

157,500-$262,500