Senior Manager, Safety Operations

Summary

Join Erasca, a clinical-stage precision oncology company, as a Senior Manager or Associate Director, Safety Operations. Reporting to the Director, Safety Systems & Quality, you will oversee vendor management for Individual Case Safety Reports (ICSR), ensuring efficiency and compliance. Responsibilities include managing global safety database activities, supporting clinical trial teams, and leading process improvements. You will collaborate with stakeholders, prepare safety plans, and participate in regulatory inspections. The ideal candidate possesses a Master's degree (or equivalent) and 5-8 years of pharmacovigilance experience, along with a strong understanding of global regulations. Erasca offers a competitive salary, annual bonus, equity grants, and a comprehensive benefits package.

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

Responsibilities

• Perform vendor oversight to ensure all pharmacovigilance activities are performed in an efficient, consistent, and compliant manner
• Coordinate day-to-day operational ICSR activities in collaboration with designated program management personnel at the vendor site(s)
• Facilitate 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
• Serve as the 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
• Support 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

Preferred Qualifications

• Experienced in pre-approval/clinical development pharmacovigilance safety reporting requirements
• Project management experience implementing processes and solutions for pharmacovigilance, safety report, and data analytics
• Experience with data entry of drug safety databases, such as Oracle Argus
• Experience in data outputs preparation for performing drug safety reports including periodic reports (DSUR, and/or PBRER)
• Experience in a startup environment developing and implementing pharmacovigilance standards, processes, and procedures for quality oversight
• Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
• Able to work in an entrepreneurial, fast paced, dynamic, team-oriented environment
• Strong oral and written communication skills
• Strong learning orientation, curiosity, and commitment to science and patients

Benefits

• Paid Time Off, Holiday, and Sick Leave
• Medical, Dental and Vision Plans
• Short- and Long-Term Disability
• Basic and Voluntary Life/AD&D Coverage
• Flexible Spending Accounts (FSA, HSA, and Commute)
• Critical Illness and Accident Coverage
• Pet Insurance
• Employee Assistance Program
• 401(k) Plan with Erasca contribution
• Opportunity to participate in an Employee Stock Purchase Program
• Annual bonus
• Equity grant at hire and annually in the form of the option to purchase stock in the future for a specified price