Summit Therapeutics, Inc. · 1 week ago
Manager, Pharmacovigilance Operations
Menlo Park, CA
Full-time
Onsite
Senior Level
$122K/yr - $143K/yr
5+ years expSummit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life and addressing serious unmet medical needs. The Manager, Pharmacovigilance Operations will oversee study management for pharmacovigilance activities, support operational activities, and ensure compliance and quality in safety reporting.
BiotechnologyHealth CareMedical DeviceTherapeutics
Responsibilities
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
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
Qualification
Required
Bachelor's 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
Benefits
Bonus
Stock
Benefits
Other applicable variable compensation
Company
Summit Therapeutics, Inc.
Summit Mission Statement: To build a viable, long-lasting health care organization that assumes full responsibility for designing, developing, trial execution and enrollment, regulatory submission and approval, as well as successful commercialization of patient, physician, caregiver, and societal-friendly medicinal therapy intended to: improve quality of life, increase potential duration of life, and resolve serious medical healthcare needs.
201-500 employees
H1B Sponsorship
Summit Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (6)
2023 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.79BKey Investors
CARB-XEurofarmaBiomedical Advanced Research and Development Authority (BARDA)
2025-10-21Post Ipo Equity· $500M
2024-09-11Post Ipo Equity· $235M
2024-06-03Post Ipo Equity· $200M
Leadership Team
Manmeet Soni
Chief Operating Officer and Board Member
Recent News
2025-12-09
2025-12-05
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