Director, Global Pharmacovigilance / Safety Operations
Immunocore
10 hours ago
Remote friendly (Gaithersburg, MD)
United States
Operations
KEY RESPONSIBILITIES
- Lead and continuously improve global safety operations processes, including case intake, processing, and submissions.
- 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 selection, configuration, validation, and lifecycle management of safety systems and tools (with IT and Safety Systems).
- Lead design, implementation, and maintenance of SOPs, work instructions, and safety operations training.
- Ensure inspection readiness; support internal audits, Health Authority inspections, and partner audits, 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) and oversee literature surveillance workflows.
- Recruit, lead, and develop a Global Safety Operations team; manage budgets and resources; serve as primary safety operations point of contact.
SUPERVISORY RESPONSIBILITY
- Direct line management of global safety operations professionals; matrix oversight of additional staff or vendor teams performing PV operational activities.
COMPETENCIES
- Strong expertise in pharmacovigilance operations (case processing, regulatory reporting, PV systems, vendor oversight) in a GVP-regulated environment.
- Demonstrated leadership and people management; experience building and developing teams.
- Strong analytical, organizational, and project management skills; ability to manage multiple priorities under tight timelines.
- Excellent written and verbal communication; able to explain complex operational/regulatory concepts to technical and non-technical audiences.
- Ability to collaborate across functions/regions and influence without direct authority.
- High integrity, discretion, and commitment to patient safety, compliance, and ethical conduct.
EXPERIENCE & KNOWLEDGE
Essential
- 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 ability to implement them operationally.
- Strong experience with safety databases/PV systems, including configuration, validation, and maintenance.
- Ability to lead/develop/manage a team and oversee PV vendors/CROs.
- Track record preparing for and supporting Health Authority inspections and audits; strong project management skills.
Desirable
- Advanced degree in a relevant scientific/health-related field.
- Experience with SDEAs and literature surveillance.
- Drive continuous improvement, process optimization, and automation in PV operations.
- Familiarity with operational support for RMPs and aggregate safety reports.
- Understanding of clinical development processes.
- Experience with global product launches and complex risk minimization measures.
- Evidence of scientific contributions (e.g., peer-reviewed publications, invited presentations, guideline development, recognized expertise in biologic safety).
EDUCATION & QUALIFICATIONS
- Bachelor’s degree (or equivalent) in a life science, pharmacy, nursing, or related health field.
- Relevant pharmacovigilance or drug safety certifications highly desirable.
US Salary Range
- 157,500–262,500
- Lead and continuously improve global safety operations processes, including case intake, processing, and submissions.
- 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 selection, configuration, validation, and lifecycle management of safety systems and tools (with IT and Safety Systems).
- Lead design, implementation, and maintenance of SOPs, work instructions, and safety operations training.
- Ensure inspection readiness; support internal audits, Health Authority inspections, and partner audits, 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) and oversee literature surveillance workflows.
- Recruit, lead, and develop a Global Safety Operations team; manage budgets and resources; serve as primary safety operations point of contact.
SUPERVISORY RESPONSIBILITY
- Direct line management of global safety operations professionals; matrix oversight of additional staff or vendor teams performing PV operational activities.
COMPETENCIES
- Strong expertise in pharmacovigilance operations (case processing, regulatory reporting, PV systems, vendor oversight) in a GVP-regulated environment.
- Demonstrated leadership and people management; experience building and developing teams.
- Strong analytical, organizational, and project management skills; ability to manage multiple priorities under tight timelines.
- Excellent written and verbal communication; able to explain complex operational/regulatory concepts to technical and non-technical audiences.
- Ability to collaborate across functions/regions and influence without direct authority.
- High integrity, discretion, and commitment to patient safety, compliance, and ethical conduct.
EXPERIENCE & KNOWLEDGE
Essential
- 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 ability to implement them operationally.
- Strong experience with safety databases/PV systems, including configuration, validation, and maintenance.
- Ability to lead/develop/manage a team and oversee PV vendors/CROs.
- Track record preparing for and supporting Health Authority inspections and audits; strong project management skills.
Desirable
- Advanced degree in a relevant scientific/health-related field.
- Experience with SDEAs and literature surveillance.
- Drive continuous improvement, process optimization, and automation in PV operations.
- Familiarity with operational support for RMPs and aggregate safety reports.
- Understanding of clinical development processes.
- Experience with global product launches and complex risk minimization measures.
- Evidence of scientific contributions (e.g., peer-reviewed publications, invited presentations, guideline development, recognized expertise in biologic safety).
EDUCATION & QUALIFICATIONS
- Bachelor’s degree (or equivalent) in a life science, pharmacy, nursing, or related health field.
- Relevant pharmacovigilance or drug safety certifications highly desirable.
US Salary Range
- 157,500–262,500