[Remote] Associate Director/Director, Drug Safety Operations

Note The job is a remote job and is open to candidates in USA. Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment. They are seeking an experienced Associate Director/Director of Pharmacovigilance Operations to lead their global pharmacovigilance infrastructure, overseeing outsourced safety operations and ensuring compliance with regulatory requirements.

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
• Oversee the lifecycle of PV operational SOPs, work instructions, and guidance documents, providing oversight to the PV vendor and CROs supporting PV activities.
• Support in the development and maintenance of Safety Management Plans (SMPs) and Pharmacovigilance Agreements (PVAs), with license partners and/or other parties.
• Support reconciliation activities between safety and clinical databases, as well as partner case exchanges.
• Support safety database configuration and maintenance, as required.
• Support PV audit and inspection activities, as required, and serve as SME during these activities.
• Oversee deviation and Corrective and Preventive Action (CAPA) activities related to, but not limited to, expedited and periodic reporting activities, as well as deviations related to case management processes, as defined in the SMPs or SOPs.
• Collaborate with Clinical Operations to deliver safety communications to sites and ethics committees.
• Assist with PV processes and initiatives, representing PV 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 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. Skills
• Degree in Life Sciences, Pharmacy, Nursing or related field required.
• Minimum of 10 years of Pharmacovigilance experience within a pharmaceutical, biotechnology or related environment, with time spent in a leadership/managerial role within PV Operations.
• Hands-on experience in vendor oversight, including governance, ensuring adherence to KPIs, and managing PVAs/SDEAs.
• Expertise in managing outsourced PV models and developing vendor oversight frameworks.
• Experience in pre- and post-marketing Safety, with proven success in biotech or small/mid-sized pharma, ideally in a lean team setting.
• Experience supporting late-stage clinical programs and regulatory submissions (e.g, NDA/BLA/MAA).
• In-depth knowledge of monitoring health authority submissions, CAPAs and relationships between vendors.
• Strong understanding of global PV regulatory requirements and timelines (e.g. FDA, EMA, PMDA, E2B R3, etc) and PV Systems (e.g. Argus, Arisglobal, Vault Safety) required.
• Able to work independently, establish work priorities, and execute decisions with minimal guidance.
• Ability to interpret related regulatory guidance and problem-solve towards a compliance approach with a background and understanding of industry best practices.
• Excellent strategic, decision-making and analytical skills.
• Excellent collaboration and strong written and verbal communication skills are required.
• Experience working with clinical databases
• Experience with PV aggregate reports, signal detection, safety surveillance, literature review, from a PV operational perspective
• Experience in oncology/hematology Benefits
• Career advancement/ development opportunities
• Competitive comp package
• Bonus
• 401K + Employer contributions
• Generous stock options
• ESPP Plan
• 20 days of PTO to start
• 18 Holidays (Including Summer & Winter Break)
• Generous Benefits Package with a variety of plans available with a substantial employer match
• Paid Paternity/Maternity Leave
• In-Office Catered lunches
• Home Office Setup
• Lifestyle Spending Stipend
• Commuter Stipend (Boston Office)
• Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more! Company Overview
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