Associate Director, Pharmacovigilance Operations
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Job Description
Associate Director overseeing outsourced pharmacovigilance operations for Summit Therapeutics, a biopharmaceutical oncology company. Managing vendors, safety systems, regulatory compliance, and inspection readiness.
Responsibilities:
- 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
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