Associate Director/Director, Drug Safety Operations

A successful candidate in this role is an experienced professional in Pharmacovigilance (PV)/Drug Safety that will be responsible for overseeing the PV vendor and process improvements, for Kura Oncology products. The candidate will be responsible for leading PV vendor oversight, implementing and monitoring key performance indicators for vendor processes, ensuring safety data quality and efficiency in the processes. The candidate will oversee workflow compliance, health authority submissions, investigation of PV related CAPAs, etc. The candidate will work cross-functionally, as needed, with key stakeholders and external resources on PV-related matters. Strong communication skills, verbal and written, with presentation skills are important in this role. This role will support the Drug Safety department and report to the Executive Director of Pharmacovigilance and Drug safety. Key responsibilities of the role include, but not limited to:

Essential Job Functions

• Oversee and contribute to the work performed by the PV vendor, including establishing Key Performance Indicators (KPIs) and monitoring all activities related to the Drug Safety function.
• Accountable for coordinating day-to-day operational Individual Case Safety Report (ICSR) activities in collaboration with designated management personnel at the vendor site(s).
• Create and/or assist with the creation of training materials, and lead training sessions for all PV processes, providing oversight to the PV vendor and CROs supporting PV activities.
• Ensure that safety reports received from clinical trials are processed in a consistent and fully compliant manner.
• Oversee expedited and periodic reporting activities for all investigational drugs, maintaining oversight to ensure that the global clinical trials case reporting process is efficient and compliant with worldwide reporting requirements.
• Assist with processes and initiatives, including but not limited to audit/inspection readiness and SDEAs/PVAs with partners, representing PV in collaboration with other functions as needed.
• Assist with the creation and/or review of Master Service Agreements (MSAs), Statements of Work (SOWs), invoices, and payment for work performed by PV vendors.
• Author and/or review PV Standard Operating Procedures (SOPs), Work Instructions, and Safety Management Plans (SMPs) in collaboration with other PV team members and cross-functional teams, as applicable.
• 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.
• Ensure that safety data quality and data integrity are maintained.

Job Requirements

• Bachelor's degree in a healthcare related field required, such as RN, LPN, PA or PharmD (preferred).
• Minimum of 5 years of experience in Drug Safety/PV, within a pharmaceutical, biotechnology or related environment, including time spent in a leadership/managerial role within PV Operations.
• In depth knowledge of monitoring health authority submissions, CAPAs and relationships between vendors.
• Experience working with PV vendors, Alliance partners and managing PVAs/SDEAs.
• Expert knowledge of relevant FDA, EMA, ICH guidelines.  and clinical development programs is required. Preferably working knowledge of EMA GVP and CIOMS.
• Experience with PV aggregate reports, signal detection, safety surveillance, literature review, from a PV operational perspective, preferred.
• Experience in oncology/hematology preferred
• Ability to interpret related regulatory guidance's and problem solve towards a compliance approach with a background and understanding of industry best practices.
• Demonstrated ability to establish and meet priorities, deadlines, strategic department goals, and objectives.
• Excellent strategic decision-making and analytical skills.
• Ability to work efficiently and effectively with minimal supervision
• Excellent collaboration and strong written and communication skills is required  

The base range for an Associate Director is $169,000 - $201,000 and a Director is $216,000 - $253,000 per year. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.