Associate Director, Drug Safety and Pharmacovigilance

🔥 0 minutes ago

❄️ Minnesota – Remote

❄️ Minnesota – Remote

💵 $165k - $179k / year

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 3%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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

• Provide strategic and operational leadership for clinical safety activities across assigned programs • Provide proactive oversight of end-to-end safety operations, including case processing, regulatory reporting, safety management plans, DSMB deliverables, and safety data reconciliation • Lead and oversee external safety vendors to ensure high-quality, timely, and compliant execution of outsourced safety activities • Lead preparation, authorship, and review of aggregate safety reports, including DSURs, PADERs, and line listings • Manage aggregate-report timelines and cross-functional inputs • Provide day-to-day direction to the Safety Operations team and communicate program updates to stakeholders • Review and assess adverse event reports, ensuring appropriate follow-up and timely expedited reporting under global regulatory requirements • Contribute to and continuously improve SOPs, work instructions, templates, and systems • Ensure procedural deviations are documented, investigated, and addressed through corrective and preventive actions • Support inspection readiness, audits, and global health authority inspections • Develop and maintain study-specific safety management plans and related documents • Ensure adherence to Safety Data Exchange Agreements and reporting requirements • Review and provide expert input on safety-related sections of clinical documents, including protocols, charters, Investigator Brochures, and Informed Consent Forms • Develop, monitor, and interpret KPIs and metrics for internal teams and external vendors • Serve as a safety subject matter expert for internal teams and external stakeholders • Perform other tasks as required to assist in company and departmental activities

🎯 Requirements

• 10+ years of drug safety/pharmacovigilance experience within a sponsor environment or a combination of sponsor and CRO roles • Bachelor’s or advanced degree in a life science or healthcare-related discipline (e.g., MD, RN, PharmD, NP, PhD, MPH) • Comprehensive knowledge of global clinical safety regulations, guidelines, and industry best practices • Extensive experience with commercial safety databases (Argus or ARIS-G), electronic data capture systems, and trial master files • Demonstrated experience preparing aggregate safety reports for investigational and/or marketed products (e.g., DSURs, PSUR/PBRERs, PADERs) and contributing to IB updates • Strong knowledge of MedDRA and WHODrug coding conventions • Excellent written and verbal communication skills • Strong interpersonal skills and ability to collaborate across functions and organizational levels • Exceptional attention to detail and ability to manage multiple priorities and documentation requirements • Strong technical and analytical skills with advanced proficiency in MS Office (Word, Excel, PowerPoint) • Ability to work independently or collaboratively, demonstrating sound judgment and decision-making in a fast-paced environment • Initiative and continuous improvement mindset focused on innovation, efficiency, and operational excellence • Flexible, adaptable, and committed to maintaining a positive and professional demeanor

🏖️ Benefits

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