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Associate Director, Drug Safety and Pharmacovigilance

4 months, 3 weeks ago
Anywhere
Full-time
Lead
Program Manager
Project and Program Management
Apply Now
Celcuity

Celcuity

Celcuity is a clinical stage biotechnology company that unravels complexity and harnesses insights to develop targeted therapies for cancer patients. Their platform provides unparalleled insights into oncogenic pathways, with their lead candidate being...

Biotechnology
11-50
Founded 2012
$214M raised
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Description

  • Provide strategic and operational leadership for clinical safety activities across assigned programs.
  • Oversee external safety vendors to ensure timely, high-quality, and compliant outsourced safety operations.
  • Lead the preparation, authorship, and review of aggregate safety reports, including DSURs, PADERs, and line listings.
  • Direct the Safety Operations team and communicate program updates to internal and external stakeholders.
  • Oversee review and assessment of adverse event reports, including follow-up and expedited reporting for global regulatory requirements.
  • Develop, implement, and continuously improve SOPs, work instructions, templates, and systems supporting safety compliance.
  • Document, investigate, and address procedural deviations through effective corrective and preventive actions.
  • Support inspection readiness and contribute to audits and global health authority inspections.
  • Develop and maintain study-specific safety management plans and related documents with clear CRO and company responsibilities.
  • Review and provide input on safety-related sections of clinical documents such as protocols, charters, Investigator Brochures, and Informed Consent Forms.

Requirements

  • 10+ years of drug safety/pharmacovigilance experience in a sponsor environment or a mix of sponsor and CRO roles.
  • Bachelor’s or advanced degree in a life science or healthcare-related discipline such as MD, RN, PharmD, NP, PhD, or MPH.
  • Comprehensive knowledge of global clinical safety regulations, guidelines, and industry best practices.
  • Extensive experience with commercial safety databases such as Argus or ARIS-G, electronic data capture systems, and trial master files.
  • Experience preparing aggregate safety reports for investigational and/or marketed products, including DSURs, PSUR/PBRERs, and PADERs.
  • Strong knowledge of MedDRA and WHODrug coding conventions.
  • Excellent written and verbal communication skills.
  • Strong interpersonal and cross-functional collaboration skills.
  • Advanced proficiency in MS Office, including Word, Excel, and PowerPoint.
  • Ability to work independently or collaboratively in a fast-paced environment with sound judgment, strong attention to detail, and multi-priority management.
  • Experience contributing to continuous improvement efforts and process enhancement initiatives.
  • Flexible, adaptable, and professional demeanor.

Benefits

  • Base salary range of $165,000 to $197,000, depending on experience and location.
  • Annual performance incentive bonus.
  • New hire equity package.
  • Medical insurance.
  • Dental insurance.
  • Vision insurance.
  • 401(k) match.
  • PTO and paid holidays.

Interested in this position?

Apply directly on the company website

Apply Now

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