Associate Director, Global Pharmacovigilance / Safety Operations
Immunocore
6 months ago
Remote friendly (Gaithersburg, MD)
United States
Operations
KEY RESPONSIBILITIES
- Lead the day-to-day execution of global safety operations, ensuring all ICSRs (clinical and post-marketing) are processed, quality-checked, and submitted within strict regulatory timelines.
- Act as the primary point of escalation for complex case-processing issues, providing technical guidance to internal staff and vendors.
- Manage the operational “rhythm” of the department, including SAE reconciliation, literature surveillance workflows, and safety query management.
- Drive day-to-day oversight of PV vendors/CROs; monitor performance against SLAs and KPIs, and lead regular operational governance meetings.
- Identify vendor performance trends and implement corrective actions or process improvements to maintain compliance.
- Support vendor selection and contract/SOW scoping by providing detailed operational requirements.
- Serve as the Operational SME during audits and Health Authority inspections; prepare “storyboards,” collate evidence of oversight, and manage operational document request logistics.
- Lead drafting/maintenance of operational SOPs, Work Instructions, and Safety Management Plans.
- Monitor PV compliance metrics (e.g., late reporting rates) and lead investigation/documentation of deviations/CAPAs.
- Represent PV Operations on Clinical Study Teams (CRF design, safety reporting sections, Investigator Brochure updates).
- Ensure operational implementation of Safety Data Exchange Agreements (SDEAs).
- Partner with Safety Systems/IT on safety database configuration and user-acceptance testing (UAT) for enhancements.
- Ensure high-quality safety data for signal detection and aggregate reporting (DSURs, PSURs/PBRERs).
COMPETENCIES
- Emerging expert in PV Ops; applies broad expertise to solve complex, sometimes undefined issues and make timely operational decisions.
- Develops and executes strategy for operational area (e.g., case management, vendor oversight); influences/negotiates operational concepts.
- Leads teams/projects and acts as a best-practices/quality resource; provides guidance, coaching, and mentorship.
PERSON SPECIFICATION
Essential
- Extensive experience 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 (configuration, validation, maintenance).
- Demonstrated ability to lead, develop, and manage PV professionals and oversee PV vendors/CROs.
- Track record supporting Health Authority inspections/audits; strong project management skills.
Desirable
- Advanced degree in a relevant scientific or health-related field.
- Experience with SDEAs and literature surveillance.
- Ability to 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 implementation/assessment of risk minimisation measures.
- Evidence of scientific contributions (e.g., publications, presentations, guideline development, or recognized biologic safety expertise).
EDUCATION & QUALIFICATIONS
- Bachelor’s degree in life science, pharmacy, nursing, or related health field.
- Proven track record managing external PV vendors and leading cross-functional projects.
- Excellent communication skills to influence stakeholders and lead high-profile meetings.
US Salary Range
- $136,500 - $227,500
- Lead the day-to-day execution of global safety operations, ensuring all ICSRs (clinical and post-marketing) are processed, quality-checked, and submitted within strict regulatory timelines.
- Act as the primary point of escalation for complex case-processing issues, providing technical guidance to internal staff and vendors.
- Manage the operational “rhythm” of the department, including SAE reconciliation, literature surveillance workflows, and safety query management.
- Drive day-to-day oversight of PV vendors/CROs; monitor performance against SLAs and KPIs, and lead regular operational governance meetings.
- Identify vendor performance trends and implement corrective actions or process improvements to maintain compliance.
- Support vendor selection and contract/SOW scoping by providing detailed operational requirements.
- Serve as the Operational SME during audits and Health Authority inspections; prepare “storyboards,” collate evidence of oversight, and manage operational document request logistics.
- Lead drafting/maintenance of operational SOPs, Work Instructions, and Safety Management Plans.
- Monitor PV compliance metrics (e.g., late reporting rates) and lead investigation/documentation of deviations/CAPAs.
- Represent PV Operations on Clinical Study Teams (CRF design, safety reporting sections, Investigator Brochure updates).
- Ensure operational implementation of Safety Data Exchange Agreements (SDEAs).
- Partner with Safety Systems/IT on safety database configuration and user-acceptance testing (UAT) for enhancements.
- Ensure high-quality safety data for signal detection and aggregate reporting (DSURs, PSURs/PBRERs).
COMPETENCIES
- Emerging expert in PV Ops; applies broad expertise to solve complex, sometimes undefined issues and make timely operational decisions.
- Develops and executes strategy for operational area (e.g., case management, vendor oversight); influences/negotiates operational concepts.
- Leads teams/projects and acts as a best-practices/quality resource; provides guidance, coaching, and mentorship.
PERSON SPECIFICATION
Essential
- Extensive experience 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 (configuration, validation, maintenance).
- Demonstrated ability to lead, develop, and manage PV professionals and oversee PV vendors/CROs.
- Track record supporting Health Authority inspections/audits; strong project management skills.
Desirable
- Advanced degree in a relevant scientific or health-related field.
- Experience with SDEAs and literature surveillance.
- Ability to 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 implementation/assessment of risk minimisation measures.
- Evidence of scientific contributions (e.g., publications, presentations, guideline development, or recognized biologic safety expertise).
EDUCATION & QUALIFICATIONS
- Bachelor’s degree in life science, pharmacy, nursing, or related health field.
- Proven track record managing external PV vendors and leading cross-functional projects.
- Excellent communication skills to influence stakeholders and lead high-profile meetings.
US Salary Range
- $136,500 - $227,500