Manager, Pharmacovigilance Operations

Summit Therapeutics Sub•Menlo Park, CA

14d•$122,000 - $143,000

About The Position

About Summit: Summit 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: The Manager, Pharmacovigilance (PV) Operations will report to the Associate or Senior Director, Pharmacovigilance Operations. The Manager PV Operations will support the PV team through study management for PV Operations, including study start-up, maintenance, and closure; vendor oversight of ICSR case management, submissions, and archival; SAE Reconciliation; aggregate report submissions; cross-functional collaboration; and business partner management (if applicable). This position will also support PV Operations leadership via operational activities including, but not limited to: Support the development of PV documentation (SOPs, WIs, SAE/pregnancy forms, ICFs) Support the development of SMP (safety management plan) Assist in tracking and managing Protocol deviation, CAPA, and PV Training management Support Safety Science on signal detection, risk management, and literature search activities Communication with internal and external shareholders Support audits and inspections

Requirements

Bachelors degree in a health related field (RN, MSN, MPH, etc.)
Minimum of 5+ years of experience in PV in Biotech, Pharma or a CRO.
Prior experience working within a Safety Database (Argus, ARISg, etc.).
Prior experience in Clinical 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.
Knowledge of ICH guidelines relevant to PV and of global PV regulations such as FDA, EMA, MHRA, Health Canada, etc.
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.

Responsibilities

Study start up: Develop/oversee SAE / Pregnancy Reporting forms, processes, and/or Safety Management Plan.
Support development of Investigator Meeting (IM) and/or Site Initiation Visit (SIV) Training materials for PV Operations.
Oversee SAE Reconciliation Plan and SMP development.
Oversee ICSR and periodic report processing and submissions for assigned studies.
Represent PV Operations in cross-functional, internal, and external study level meetings.
Resolve study level issues pertaining to PV Operations.
Support the PV Operations Team in providing study specific metrics, (KPIs and KQIs).
Oversee SAE Reconciliation for assigned studies.
Oversee completion/closure of all applicable ICSRs and their submissions.
Oversee safety document archival.
Support inspection readiness relating to PV activities.
Routine monitoring of compliance including monitoring of KPIs and KQIs to assess PV quality from CROs, vendors, external partners, and internal stakeholders; oversight of case processing activities and submission of SUSARs; submission of aggregate reports (e.g. DSUR, PSUR, PADER, 6MLL/3MLL); development and implementation of a master SMP; and oversight of external shareholders, license partners and vendors through development, implementation, and compliance of Pharmacovigilance Agreements (PVAs) and/or Safety Data Exchange Agreements (SDEAs).
Assist in the development of PV Standard Operating Procedures (SOPs), and Working Instructions (WIs); Assist in the review of cross-departmental documents where PV holds responsibility for a step in the process; Support the maintenance of Regulatory Intelligence for regulatory requirements of Safety Reports by different Regulatory Authorities.
Support Safety Science with signal management and literature search activities with internal and external stakeholders; Support cross-functional teams in overall Safety Management and risk minimization measures in support of clinical development, regulatory filings, and safety reporting requirements; Work with Quality Team to plan, execute and report audits of vendors, partners and CROs; Work with Quality Team to support external audits and inspections.
All other duties as assigned