Job Title: Director, Safety Physician

Department: Patient Safety & PV

Location: Remote Ireland

Our Mission:

To build a viable long-lasting health care organization that assumes full responsibility for designing, developing, trial enrollment, regulatory approval and commercializing patient, physician, caregiver, payor, and societal friendly medicinal therapy intended to improve quality of life, increase potential duration of life and resolve serious medical healthcare needs. We will accomplish this by building a team of world class scientists and business administrators that apply themselves to this mission.

We have in-licensed Ivonescimab, which is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. We plan to initiate clinical studies in the following NSCLC indications:

• Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) (“HARMONi”)
• Ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients (“HARMONi-3”)

Overview of Role:

Reporting to the VP of Patient Safety & Pharmacovigilance (PSPV), the Safety Physician Director will be responsible for investigational and marketed product pharmacovigilance activities. Primary responsibilities include medical review of individual case safety reports (ICSRs), strategic input for adverse event monitoring and signal detection, ensuring global pharmacovigilance regulatory requirements are met, and safeguarding patients enrolled in our trials or administered our products.

?Role and Responsibilities:

• Implement the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. Evaluate medical accuracy of ICSRs reports.
• Prepare Analysis of Similar Events (AOSE) for IND safety reports.
• Confirm criteria and content for expedited reporting and unblinding (e.g. SUSAR or urgent safety issues).
• Lead or actively contribute to the preparations and presentation of safety information to the Drug Safety Committee (DSC), Product Safety Review Team (PSRT), Independent Data Monitoring Committees (IDMCs), and other internal and external stakeholders/parties, when required.
• Interact and liaise with PV vendor medical reviewer and Summit Medical Monitors.
• Review individual and aggregate safety data from safety database on a scheduled basis for signal detection.
• Act as product lead and/or therapeutic area lead as assigned.
• Share ICSR case quality issues with PV Operations as appropriate, and support Quality Assurance of ICSR medical review.
• Implement appropriate case follow up / queries per SOPs.
• Develop and support medical coding conventions, and systematic process improvements for ICSR medical review.
• Support reconciliation between Safety and Clinical databases.
• Develop, maintain, update, review and approve list of expected terms via the Reference Safety Information (RSI) in the IB, in collaboration with development partner and cross-functional teams.
• Act as Medical Safety Review process lead and support the development, training on and implementation of new processes in Medical Safety Review.
• Mentor junior medical safety reviewers as needed and applicable, provide direct managerial responsibilities for medical safety reviewers on therapeutic or functional team.
• Maintain a state of inspection readiness, and act as functional representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility.
• Provide expertise and guidance on teams for interdepartmental and cross-functional initiatives including process improvement, standards development, Standard Operating Procedures (SOP) creation, and metrics with regards to medical safety review.
• Author, review and/or approve safety content of various aggregate safety summary documents such as DSURs, PBRERs, Regulatory Response documents, Safety Signal Evaluation documents, etc., when requested.
• Perform other duties related to the position as necessary as defined in SOPs or as requested by their supervisor.

Experience, Education and Specialized Knowledge and Skills:

• MD/DO or international equivalent plus 5 years relevant work as a safety physician.
• Working knowledge of case management and medical review processes and procedures.
• Clinical knowledge of oncology therapeutic area patient populations and drug classes (immunotherapy and chemotherapy) is preferred.
• Proficiency in technical safety systems.
• Strong knowledge and understanding of global safety reporting and pharmacovigilance requirements, aggregate reporting, and signal detection in both clinical trials and post market safety.