Drug Safety Specialist

🔥 0 minutes ago

❄️ Minnesota – Remote

❄️ Minnesota – Remote

💵 $95k - $110k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

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Celcuity

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Celcuity is a clinical-stage biotechnology company developing targeted therapies that block the PI3K/AKT/mTOR (PAM) pathway to treat multiple solid tumors. Its lead candidate, gedatolisib, is a potential first-in-class pan-PI3K and mTORC1/2 inhibitor being evaluated in breast and prostate cancer trials. The company advances a focused pipeline aimed at delivering transformative, targeted cancer treatments and conducts clinical development and data-driven research to support regulatory and medical adoption.

📋 Description

• Oversee serious adverse event case processing and reporting for Celcuity products in clinical trials • Serve as a liaison to CROs and company personnel for safety-related issues • Manage the Safety Department mailbox, tracking documents, and safety requests • Perform quality reviews on safety cases, including case presentation and medical coding • Generate safety queries and determine when cases are complete and ready to close • Manage reconciliations between safety and clinical vendors and between Celcuity and business partners • Review operational reports from safety vendors and implement process improvements • Manage, quality review, and provide safety documents for the trial master file • Support Safety Department meetings through agenda development, minutes, and action-item tracking • Assist or lead safety activities for study start-up and closeout • Communicate expedited safety reporting needs and track cases for on-time reporting • Participate in controlled-document development and safety data exchange agreement activities • Support audits and inspections, including preparation

🎯 Requirements

• Bachelor’s degree in health or life sciences field required • Degree in nursing, pharmacy, or another healthcare-related field preferred • 2–5 years of experience in clinical trial drug safety operations, or combined clinical trial and post-marketing drug safety operations experience, in biotechnology, pharmaceutical, and/or CRO settings • Working knowledge of ICH/GCP guidelines and US CFR 314.80 and 312.32 • Knowledge of MedDRA and WHO_DRUG dictionaries • Excellent written and verbal communication skills • Strong interpersonal skills • Attention to detail and ability to manage multiple processes and documentation requirements • Strong technical and analytical skills • Advanced knowledge of MS Office, including Word, Excel, and PowerPoint • Experience with Argus, electronic data capture (EDC), and trial master file (TMF) system-based software required • Ability to work independently or in a team • Outstanding organizational and prioritization skills • Independent, sound decision-making and critical-thinking skills • Continuous improvement mindset • Flexibility and willingness to learn and adapt to business and site needs

🏖️ Benefits

• Annual performance incentive bonus • New hire equity package • Medical insurance • Dental insurance • Vision insurance • 401(k) match • PTO • Paid holidays