Summit Therapeutics, Inc. · 1 month ago
Associate Director, Pharmacovigilance Operations
Menlo Park, CA
Full-time
Onsite
Lead/Staff, Director/Executive
$158K/yr - $185K/yr
10+ years expSummit Therapeutics Inc. is a biopharmaceutical oncology company dedicated to improving quality of life and addressing serious unmet medical needs. They are seeking an experienced Associate Director of Pharmacovigilance Operations to oversee safety operations, ensure regulatory compliance, and contribute to strategic safety planning in both clinical and post-market settings.
BiotechnologyHealth CareMedical DeviceTherapeutics
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/partnerships
Participate 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
Qualification
Required
Degree in Life Sciences, Pharmacy, Nursing or related field
Minimum 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
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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