Director, Safety Operations

Immunocore; Gaithersburg, Northern (MD, KY); Hybrid; USD 158,000 - 263,000; Full time

Job summary

Immunocore is seeking a Director of Safety Operations to lead end-to-end pharmacovigilance activities for development and marketed products. You will drive case intake, processing, regulatory reporting, and vendor oversight in a GVP-regulated environment.

Focus on ensuring inspection readiness, robust safety systems, and cross-functional collaboration with Safety Physicians and IT teams to deliver high-quality safety data throughout the product lifecycle.

Qualifications

• Extensive experience in pharmacovigilance operations and global ICSR management.
• Strong knowledge of global PV regulations (GVP, FDA, EMA, MHRA, ICH).
• Proven ability to lead and manage PV vendors/CROs and safety systems.

Responsibilities

• Lead and continually improve global safety operations processes across clinical and postmarketing settings.
• Oversee timely and compliant case processing and regulatory reporting of ICSRs.
• Ensure inspection readiness and support Health Authority inspections and audits.

Skills

Pharmacovigilance operations

Global ICSR management

Regulatory reporting

Vendor oversight

Leadership

Education

Bachelor's degree in life science or related field

Tools

PV systems (MedDRA/ICh)

Job description

| | || --- | --- || | Gaithersburg, MD, Radnor PA, Oxford, UK, Remote US || | 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 || | Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry’s most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions. Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases. At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients’ lives, advancing medicine, and supporting one another in these pursuits. Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law. |