Associate Director, Drug Safety and Pharmacovigilance

This is a fully remote position, open to applicants in Minnesota.

📋 Description

• Deliver strategic and operational leadership for clinical safety initiatives across designated programs.

• Provide proactive oversight of comprehensive safety operations, which include case processing, regulatory reporting, safety management plans, DSMB deliverables, and safety data reconciliation.

• Lead and manage external safety vendors to guarantee the high-quality, timely, and compliant execution of outsourced safety tasks.

• Oversee the preparation, authorship, and review of aggregate safety reports, such as DSURs, PADERs, and line listings.

• Manage timelines for aggregate reporting and coordinate cross-functional contributions.

• Offer daily guidance to the Safety Operations team and relay program updates to stakeholders.

• Evaluate and analyze adverse event reports, ensuring appropriate follow-up and prompt expedited reporting in compliance with global regulatory standards.

• Contribute to and enhance SOPs, work instructions, templates, and systems.

• Ensure that procedural deviations are documented, investigated, and resolved through corrective and preventive measures.

• Assist in inspection readiness, audits, and global health authority evaluations.

• Develop and sustain study-specific safety management plans and associated documents.

• Ensure compliance with Safety Data Exchange Agreements and reporting obligations.

• Review and provide expert insights on safety-related components of clinical documents, including protocols, charters, Investigator Brochures, and Informed Consent Forms.

• Develop, monitor, and interpret KPIs and metrics for both internal teams and external vendors.

• Act as a safety subject matter expert for internal teams and external partners.

• Perform other duties as necessary to support company and departmental objectives.

⛳️ Requirements

• Over 10 years of experience in drug safety/pharmacovigilance within a sponsor environment or a mix of sponsor and CRO roles.

• Bachelor’s or advanced degree in a life science or healthcare-related field (e.g., MD, RN, PharmD, NP, PhD, MPH).

• Extensive understanding of global clinical safety regulations, guidelines, and best practices in the industry.

• Significant experience with commercial safety databases (such as Argus or ARIS-G), electronic data capture systems, and trial master files.

• Proven track record in preparing aggregate safety reports for investigational and/or marketed products (e.g., DSURs, PSUR/PBRERs, PADERs) and contributing to Investigator Brochure updates.

• Strong familiarity with MedDRA and WHODrug coding standards.

• Exceptional written and verbal communication abilities.

• Strong interpersonal skills and capacity to collaborate across various functions and organizational levels.

• Keen attention to detail with the ability to manage multiple priorities and documentation needs.

• Strong technical and analytical capabilities, with advanced proficiency in MS Office (Word, Excel, PowerPoint).

• Ability to work independently or as part of a team, demonstrating sound judgment and decision-making in a dynamic environment.

• Initiative and a mindset focused on continuous improvement, innovation, efficiency, and operational excellence.

• Adaptable, flexible, and dedicated to maintaining a positive and professional attitude.

🏝️ Benefits

• Annual performance incentive bonus.

• New hire equity package.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) match.

• Paid Time Off (PTO).

• Paid holidays.