Associate Director, Pharmacovigilance Operations at Summit Therapeutics Sub

About SummitSummit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life increasing potential duration of life and resolving serious unmet medical needs. At Summit we believe in building a team of world class professionals who are passionate about this mission and it is our people who drive this mission to reality. Summits core values include integrity passion for excellence purposeful urgency collaboration and our commitment to people. Our employees are truly the heart and soul of our culture and they are invaluable in shaping our journey toward excellence. Summits team is inspired to touch and help change lives through Summits clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies including: Non-small Cell Lung Cancer (NSCLC) HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. Colorectal Cancer (CRC) HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than Chinas National Medical Products Administration (NMPA). Summit is headquartered in Miami Florida and has additional offices in California New Jersey the UK and Ireland. Overview of Role:We are seeking an experienced and strategic Associate Director of Pharmacovigilance Operations to support our global PV operational infrastructure. This role is accountable for the oversight of all outsourced safety operations vendor governance and operational compliance across clinical and/or post-market settings. The Associate Director PV Operations will play a critical role in scaling PV operations capabilities ensuring inspection readiness regulatory compliance and contributing to strategic safety planning. The ideal candidate has experience supporting both clinical and post-market programs and can lead vendor governance inspection readiness and PV systems management.This role will support the PSPV department and report to the Senior Director PV Operations and Compliance. Key responsibilities of the role include but are not limited to:Role and Responsibilities:Oversee the process for ICSR collection processing reconciliation and reporting including associated quality activities to ensure regulatory timelines and global standards are met.Provide oversight and support of the PV vendor activities including establishing and monitoring key performance indicators (KPIs) always ensuring inspection-readiness.Oversee global compliance with pharmacovigilance regulations including timely ICSR submissions quality case processing and aggregate reporting support.Identify and support the development of PV operational SOPs work instructions and guidance documents. Identify and support in the development and maintenance of Safety Management Plans (SMPs) and Pharmacovigilance Agreements (PVAs)/Safety Data Exchange Agreements (SDEAs) with license partners and/or other parties.Oversee reconciliation activities between safety and clinical databases as well as partner case exchanges. Oversee safety database configuration and maintenance as required.Support PV audit and inspection activities as required and serve as SME during these activities.Support and oversee deviation and Corrective and Preventive Action (CAPA) activities related to but not limited to expedited and periodic reporting activities deviations related to case management processes as defined in the SMPs or SOPs and PVA/SDEA compliance.Collaborate with Clinical Operations to deliver safety communications to sites and ethics committees.Assist with PV Operational processes and initiatives representing PV Operations in collaboration with other functions as needed.Work cross-functionally with Regulatory Affairs Clinical Operations Clinical Development Data Management Quality Assurance and Medical Affairs to ensure appropriate PV processes are in place and adhered to.Serves as key point of contact between PV Operations and the CROs regarding PV operation management.Provide PV operational expertise in development of RMPs REMS DSURs PSURs and other safety deliverables.Represent PV operations in internal safety governance forums and external collaborations/partnershipsParticipate in cross-functional monitoring of study data as necessary.Assist in the development review and management of departmental budget MSAs SOWs invoices and payment of work performed by vendors.All other duties as assigned Experience Education and Specialized Knowledge and Skills:Degree in Life Sciences Pharmacy Nursing or related fieldMinimum of 10 years of experience in PV in Biotech Pharma or a CRO. Hands-on experience in vendor oversight including governance ensuring adherence to KPIs and managing PVAs/SDEAs.Prior experience working within a Safety Database (Argus ARISg etc.).Prior experience in Clinical and Post-Market Safety and Risk Management with an understanding of the various stages of the product life cycle.Experience working in a matrixed and fast-paced environment and able to manage multiple projects with an ability to creatively resolve issues and mitigate risks.Ability to translate PV knowledge and expertise into action.Demonstrated ability to monitor multiple projects and actively track timelines.Strong understanding of global PV regulatory requirements and timelines (e.g. FDA EMA MHRA PMDA E2B R3 etc) and PV Systems (e.g. Argus Arisglobal Vault Safety).Experience working with management and cross-functional stakeholders (e.g. Clinical Regulatory Quality) including an ability to influence without authority. Effective collaboration and interpersonal skills.Ability to work independently establish work priorities and execute decisions with minimal guidance.Ability to interpret related regulatory guidance and problem-solve towards a compliant approach with a background and understanding of industry best practices.Excellent decision-making and analytical skills.The pay range for this role is $158000-$185000 annually. Actual compensation packages are based on several factors that are unique to each candidate including but not limited to skill set depth of experience certifications and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus stock benefits and/or other applicable variable compensation.Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summits Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.Required Experience:Director Key Skills Business,Information Management,Accounting,Corporate Risk Management,Faculty,Jms Employment Type : Full-Time Experience: years Vacancy: 1 Yearly Salary Salary: 158000 - 185000