Director, Global Pharmacovigilance / Safety Operations
Immunocore
5 hours ago
Remote friendly (United States)
United States
Operations
KEY RESPONSIBILITIES
- Lead and continuously improve global safety operations processes (case intake, processing, and submissions) aligned with global PV regulations and company policies.
- Oversee timely and compliant 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 life-cycle management of safety systems/tools in partnership with IT and Safety Systems.
- Lead design, implementation, and maintenance of SOPs, work instructions, and training for safety operations.
- Ensure inspection readiness; support internal audits, Health Authority inspections, and partner audits; coordinate 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 to Safety Management Teams and cross-functional project teams, managing feasibility, timelines, and compliance risks.
- Lead operational aspects of safety data exchange agreements (SDEAs) and oversee literature surveillance workflows.
- Recruit, lead, and develop the Global Safety Operations team; manage budgets/resources; act as primary point of contact for safety operations.
SUPERVISORY RESPONSIBILITY
- Direct line management for a team of global safety operations professionals; matrix oversight of additional staff or vendor teams.
COMPETENCIES
- Strong pharmacovigilance operations expertise (case processing, regulatory reporting, PV systems, vendor oversight) in a GVP-regulated environment.
- Demonstrated leadership and people management experience.
- Strong analytical, organizational, and project management skills; ability to manage multiple priorities and deliver to tight timelines.
- Excellent written and verbal communication skills.
- Ability to collaborate across functions/regions and influence without direct authority.
- High integrity, discretion, and commitment to patient safety and compliance.
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 operationally.
- Strong experience with safety databases/PV systems (configuration, validation, maintenance).
- Ability to lead/develop a PV team and oversee PV vendors/CROs.
- Proven track record supporting Health Authority inspections and audits.
- Desirable: Advanced degree; SDEA and literature surveillance experience; continuous improvement/automation; support of RMPs and aggregate safety reports; understanding clinical development; experience with global product launches and complex risk minimisation measures; scientific contributions (publications/presentations/guideline development) in biologic safety.
EDUCATION & QUALIFICATIONS
- Bachelor’s degree (or equivalent) in a life science, pharmacy, nursing, or related health field.
- Relevant pharmacovigilance/drug safety certifications highly desirable.
US Salary Range
- 157,500–262,500
- Lead and continuously improve global safety operations processes (case intake, processing, and submissions) aligned with global PV regulations and company policies.
- Oversee timely and compliant 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 life-cycle management of safety systems/tools in partnership with IT and Safety Systems.
- Lead design, implementation, and maintenance of SOPs, work instructions, and training for safety operations.
- Ensure inspection readiness; support internal audits, Health Authority inspections, and partner audits; coordinate 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 to Safety Management Teams and cross-functional project teams, managing feasibility, timelines, and compliance risks.
- Lead operational aspects of safety data exchange agreements (SDEAs) and oversee literature surveillance workflows.
- Recruit, lead, and develop the Global Safety Operations team; manage budgets/resources; act as primary point of contact for safety operations.
SUPERVISORY RESPONSIBILITY
- Direct line management for a team of global safety operations professionals; matrix oversight of additional staff or vendor teams.
COMPETENCIES
- Strong pharmacovigilance operations expertise (case processing, regulatory reporting, PV systems, vendor oversight) in a GVP-regulated environment.
- Demonstrated leadership and people management experience.
- Strong analytical, organizational, and project management skills; ability to manage multiple priorities and deliver to tight timelines.
- Excellent written and verbal communication skills.
- Ability to collaborate across functions/regions and influence without direct authority.
- High integrity, discretion, and commitment to patient safety and compliance.
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 operationally.
- Strong experience with safety databases/PV systems (configuration, validation, maintenance).
- Ability to lead/develop a PV team and oversee PV vendors/CROs.
- Proven track record supporting Health Authority inspections and audits.
- Desirable: Advanced degree; SDEA and literature surveillance experience; continuous improvement/automation; support of RMPs and aggregate safety reports; understanding clinical development; experience with global product launches and complex risk minimisation measures; scientific contributions (publications/presentations/guideline development) in biologic safety.
EDUCATION & QUALIFICATIONS
- Bachelor’s degree (or equivalent) in a life science, pharmacy, nursing, or related health field.
- Relevant pharmacovigilance/drug safety certifications highly desirable.
US Salary Range
- 157,500–262,500