Associate Director, Pharmacovigilance Operations

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $174k - $205k / year

⏰ Full Time

🟠 Senior

⚙️ Operations

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Summit Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2003

🏥 Healthcare

💼 Consulting

📣 Marketing

🔥 Funding within the last year

💰 $500M Post-IPO Equity - Summit Therapeutics on 2025-10

Healthcare • Consulting • Marketing

Summit Therapeutics, Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of novel medicinal therapies to improve quality and duration of life for patients with serious unmet medical needs. The company is advancing ivonescimab (SMT112), a novel bispecific antibody targeting PD-1 and VEGF, through multiple Phase 3 clinical trials for non-small cell lung cancer and other solid tumors under license from Akeso. Summit emphasizes clinical development, regulatory filing strategies, and potential commercialization in its licensed territories while promoting patient- and caregiver-friendly treatment options.

📋 Description

• Oversee ICSR collection, processing, reconciliation, and reporting, including quality activities • Oversee PV vendor activities, KPIs, governance, and inspection readiness • Ensure global compliance with pharmacovigilance regulations and reporting timelines • Support development of PV SOPs, work instructions, and guidance documents • Develop and maintain Safety Management Plans and Pharmacovigilance/Safety Data Exchange Agreements • Oversee reconciliation between safety and clinical databases and case exchanges with partners • Oversee safety database configuration and maintenance • Support PV audits and inspections as a subject-matter expert • Oversee deviations and CAPA activities • Collaborate with Clinical Operations, Regulatory, and other cross-functional teams on safety submissions • Represent PV Operations in operational processes, initiatives, governance forums, and external partnerships • Serve as key PV Operations contact for CROs • Provide PV expertise for RMPs, REMS, DSURs, PSURs, and other safety deliverables • Participate in cross-functional study-data monitoring • Assist with departmental budgets, MSAs, SOWs, invoices, and vendor payments

🎯 Requirements

• 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, KPI adherence, and management of PVAs/SDEAs • Prior experience working within a Safety Database such as Argus or ARISg • Prior experience in Clinical and Post-Market Safety and Risk Management across product life-cycle stages • Experience working in a matrixed and fast-paced environment and managing multiple projects • Ability to creatively resolve issues and mitigate risks • Strong understanding of global PV regulatory requirements and timelines, including FDA, EMA, MHRA, PMDA, and E2B R3 • Experience with PV systems such as Argus, ArisGlobal, and Vault Safety • Experience working with management and cross-functional stakeholders • Ability to work independently, establish priorities, and execute decisions with minimal guidance • Ability to interpret regulatory guidance and develop compliant approaches • Excellent decision-making and analytical skills

🏖️ Benefits

• Bonus • Stock • Benefits • Variable compensation may be included in the total compensation package