Summit Therapeutics, Inc.
Associate Director, Pharmacovigilance Operations
Summit Therapeutics, Inc., Menlo Park, California, United States, 94029
Associate Director, Pharmacovigilance Operations
Join Summit Therapeutics, Inc. as an experienced and strategic Associate Director of Pharmacovigilance Operations. This role oversees outsourced safety operations, vendor governance, and compliance across clinical and post‑market settings. The Associate Director supports scaling PV capabilities, ensuring inspection readiness, regulatory compliance, and strategic safety planning.
Overview Of Role Accountable for the oversight of all outsourced safety operations, vendor governance, and operational compliance across clinical and post‑market settings. The Associate Director will lead vendor governance, inspection readiness, and PV systems management.
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, establishing and monitoring key performance indicators (KPIs) and 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.
Support 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 and partner case exchanges.
Oversee safety database configuration and maintenance as required.
Support PV audit and inspection activities, serving as SME during these activities.
Support and oversee deviation and Corrective and Preventive Action (CAPA) activities related to expedited and periodic reporting, deviations related to case management processes, 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.
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.
Serve 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.
Perform other duties as assigned.
Experience, Education, and Specialized Knowledge and Skills
Degree in Life Sciences, Pharmacy, Nursing or related field.
Minimum 10+ years of experience in PV in Biotech, Pharma or a CRO.
Hands‑on experience in vendor oversight, governance, ensuring adherence to KPIs, and managing PVAs/SDEAs.
Prior experience working within a safety database (Argus, ARISg, etc.).
Experience in clinical and post‑market safety and risk management across product life cycle stages.
Experience working in a matrixed and fast‑paced environment, managing multiple projects and mitigating risks.
Ability to translate PV knowledge into action.
Demonstrated ability to monitor multiple projects and track timelines.
Strong understanding of global PV regulatory requirements and PV systems.
Experience working with cross‑functional stakeholders and influencing without authority.
Effective collaboration and interpersonal skills.
Ability to work independently, prioritize work, and execute decisions with minimal guidance.
Ability to interpret regulatory guidance and problem‑solve toward a compliant approach.
Excellent decision‑making and analytical skills.
The pay range for this role is $158,000–$185,000 annually. Actual compensation packages are based on factors including skill set, experience, certifications, and work location. The total compensation package may also include bonus, stock, benefits, and other variable compensation.
Summit does not accept referrals from employment businesses or agencies on this site. All employment businesses/agencies must contact Summit’s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates.
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Overview Of Role Accountable for the oversight of all outsourced safety operations, vendor governance, and operational compliance across clinical and post‑market settings. The Associate Director will lead vendor governance, inspection readiness, and PV systems management.
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, establishing and monitoring key performance indicators (KPIs) and 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.
Support 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 and partner case exchanges.
Oversee safety database configuration and maintenance as required.
Support PV audit and inspection activities, serving as SME during these activities.
Support and oversee deviation and Corrective and Preventive Action (CAPA) activities related to expedited and periodic reporting, deviations related to case management processes, 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.
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.
Serve 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.
Perform other duties as assigned.
Experience, Education, and Specialized Knowledge and Skills
Degree in Life Sciences, Pharmacy, Nursing or related field.
Minimum 10+ years of experience in PV in Biotech, Pharma or a CRO.
Hands‑on experience in vendor oversight, governance, ensuring adherence to KPIs, and managing PVAs/SDEAs.
Prior experience working within a safety database (Argus, ARISg, etc.).
Experience in clinical and post‑market safety and risk management across product life cycle stages.
Experience working in a matrixed and fast‑paced environment, managing multiple projects and mitigating risks.
Ability to translate PV knowledge into action.
Demonstrated ability to monitor multiple projects and track timelines.
Strong understanding of global PV regulatory requirements and PV systems.
Experience working with cross‑functional stakeholders and influencing without authority.
Effective collaboration and interpersonal skills.
Ability to work independently, prioritize work, and execute decisions with minimal guidance.
Ability to interpret regulatory guidance and problem‑solve toward a compliant approach.
Excellent decision‑making and analytical skills.
The pay range for this role is $158,000–$185,000 annually. Actual compensation packages are based on factors including skill set, experience, certifications, and work location. The total compensation package may also include bonus, stock, benefits, and other variable compensation.
Summit does not accept referrals from employment businesses or agencies on this site. All employment businesses/agencies must contact Summit’s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates.
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