Senior Manager - Associate Director, Safety Operations

March 19

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Logo of Erasca, Inc.

Erasca, Inc.

Erasca, Inc. is a clinical-stage precision oncology company committed to eradicating cancer by targeting one of cancer's most commonly mutated pathways, the RAS/MAPK pathway. The company is dedicated to developing a modality-agnostic portfolio of therapeutic programs designed to thoroughly shut down the RAS/MAPK pathway, which affects millions of lives globally each year. Erasca is advancing a robust pipeline with the potential to transform cancer treatment and improve the lives of patients suffering from various types of cancer. With a focus on groundbreaking science in oncology, Erasca aims to bring new hope to patients and lead the way in precision oncology innovations.

51 - 200 employees

Founded 2020

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $100M Post-IPO Equity on 2022-12

📋 Description

• Reporting to the Director, Safety Systems & Quality. • Provides oversight and management of vendors, business partners, and individuals involved with the Individual Case Safety Report (ICSR) process. • Oversee global safety database activities including serious adverse event reporting metrics. • Lead the planning, execution, and implementation of process improvements and procedures related to ICSR reporting.

🎯 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. • Experience participating in quality inspections and audits. • Proficiency in verbal and written communication; great attention to detail, ability to meet project deadlines. • Desired: 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.

🏖️ Benefits

• Paid Time Off • Holiday • 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 Employee Stock Purchase Program

Apply Now

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