Associate Director, Drug Safety and Pharmacovigilance
$165,000–$179,000 year
RemoteUnited States
Job Summary
Provide strategic and operational leadership for clinical safety activities, overseeing end-to-end safety operations including case processing, regulatory reporting, and safety management plan development. Lead the preparation and review of aggregate safety reports such as DSURs and PADERs while managing timelines and cross-functional inputs. Provide day-to-day direction to the Safety Operations team, ensuring compliance with global regulatory requirements and supporting inspection readiness activities. Serve as the safety subject matter expert for internal teams and external stakeholders, offering guidance on regulatory expectations and best practices. Develop and maintain study-specific safety management plans and contribute to the continuous improvement of SOPs and systems.
Required Qualifications
- 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 working 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, with the ability to convey complex information clearly and concisely
- Strong interpersonal skills with the ability to collaborate effectively 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
- Naturally takes initiative, contributing to continuous improvement efforts and proactively identifying opportunities to enhance processes within the department
- Continuous improvement mindset with a focus on innovation, efficiency, and operational excellence
- Flexible, adaptable, and committed to maintaining a positive and professional demeanor
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