Senior Manager/Assoc Director, Safety Operations

Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer’s most commonly mutated signaling cascades, the RAS/MAPK pathway, which affects approximately 5.5 million lives each year worldwide. The name “Erasca” has an important embedded meaning: it is a contraction of our audacious hope to “erase cancer” that drives our mission and everything that we do on behalf of patients with cancer.

Position Summary:  

Reporting to the Director, Safety Systems & Quality, the Senior Manager or Associate Director, Safety Operations provides oversight and management of vendors, business partners, and individuals involved with the Individual Case Safety Report (ICSR) process to ensure efficiency, quality, and compliance with internal procedures and global regulations. They also oversee global safety database activities including serious adverse event reporting metrics, support individual study teams, and collaborate on the support of risk management and pharmacovigilance for all Erasca clinical trials. Additionally, the Senior Manager or Associate Director, Safety Operations leads the planning, execution, and implementation of process improvements and procedures related to ICSR reporting.

Essential Duties and Responsibilities:  

• Responsible for performing vendor oversight to ensure all pharmacovigilance activities are performed in an efficient, consistent, and compliant manner.
• Accountable for coordination of day-to-day operational ICSR activities in collaboration with designated program management personnel at the vendor site(s).
• Responsible for the facilitation of training and development of vendor personnel (remotely) , driving the development of self-sufficiency at the vendor level.
• Manage Vendor Oversight including tracking of KPIs, metrics, and on-time reporting.
• Ensure safety reports received from clinical trials are processed in a consistent and fully compliant manner.
• Oversee SAE/SUSAR reporting activities for all investigational drugs (Maintain oversight to ensure Global clinical trials case reporting process is efficient and compliant with worldwide reporting requirements).
• Ensure Global clinical trials case reporting process is efficient and compliant with reporting requirements detailed in the safety management plans (SMP)/ PV agreements and safety data exchange agreements.
• Point of contact for key stakeholders for safety-related activities within the SMPs and PV agreements.
• Lead preparation of safety-reporting/management plans with partners and CROs (i.e., SMPs and PVAs).
• Participate and contribute to Study Management Team (SMT) meetings.
• Provide guidance and support to project teams for safety reporting-related areas, including protocol development and study conduct.
• Oversee reconciliation activities with other departments and vendors for Erasca products
• Supports the development of Erasca Global Patient Safety infrastructure, including new safety projects..
• Lead and/or contribute to the creation and approval of PV SOPs and Work instructions.
• Drive the resolution of PV vendor’s deviation and CAPA activities in relation to, but not limited to, late SUSAR or aggregate report submissions as well as deviations relating to case management processes as defined per the SMPs and/or SOPs.
• Participate in regulatory inspections and PV audits to ensure the quality, integrity, and compliance with pharmacovigilance and safety reporting requirements per SOPs and global regulations.
• Perform all duties in keeping with the Company’s core values, policies and all applicable regulations. 

Required Education and Experience: 

Minimum Requirements:  

• Master’s degree in a relevant life sciences field, advanced nursing degree, or pharmacy degree is highly preferred; for exceptional candidates, a Bachelor of Science combined with relevant experience will be considered, or comparable experience.
• A minimum of 5 - 8 years of experience in pharmacovigilance with a focus on operations is required.
• Solid understanding and working knowledge of US and ex-US pharmacovigilance regulatory requirements (e.g., US Code of Federal Regulations; European Union GVP legislation; and ICH Guidelines)
• Experience participating in quality inspections and audits.
• Proficiency in verbal and written communication; great attention to detail, ability to meet project deadlines.