We're seeking a Drug Safety Associate to support a global pharmacovigilance initiative aimed at addressing outstanding case compliance activities. This role is project-focused rather than routine operational work, as you'll assist in closing a backlog of root cause analyses (RCAs) related to safety cases submitted late to health authorities, CROs, and business partners. Your contributions will also help drive broader quality and compliance improvements.

About the Company

Planet Pharma is an American staffing agency with its headquarters in Chicago and a regional office in Central London. We provide global staffing services and have invested in creating a robust international platform that operates compliantly in over 30 countries, with a network of over 2500 active contractors.

The Role

In this role, you will:

• Conduct root cause analysis (RCA) on Individual Case Safety Reports (ICSRs) submitted late to health authorities, CROs, and business partners.
• Enter RCA conclusions into the global safety database and perform quality control on that data.
• Maintain and manage an Excel-based RCA tracking tool.
• Facilitate weekly/bi-weekly meetings with case processing vendors to discuss and resolve open RCAs.
• Participate in weekly Compliance team meetings and project team calls with colleagues across regions.
• Support PV and local affiliate staff during internal audits, external Health Authority inspections, and license partner audits, including on-site support as needed.
• Contribute to broader project and process improvement initiatives.
• Ensure clear and timely communication across cross-functional teams, vendors, and business partners.

Requirements

• A completed Bachelor's degree.
• Minimum 2 years of experience in Pharmacovigilance, Biotechnology, a Contract Research Organization, or a related field, particularly in quality assurance, data assurance, case processing, or similar roles.
• Working knowledge of quality investigation concepts (e.g., root cause analysis, fishbone diagrams, 5 Whys, CAPAs).
• Good understanding of PV processes (e.g., adverse event reporting) and their integration into the broader PV system.
• Familiarity with global health authority safety regulations (e.g., ICH, CFR 21, FDA, EU GVP modules, JP regulations) for marketed and investigational products.
• Proficiency in Excel and SharePoint, and experience working with pharmacovigilance safety databases or similar systems.
• Strong project management and stakeholder management skills.
• Experience in driving cross-functional initiatives and tracking deliverables to completion is preferred.
• Ability to work effectively in a global, multicultural team environment.
• Excellent written and verbal English communication skills.
• A proactive and curious mindset, open to learning new tasks and navigating ambiguity.

What We Offer

This position provides an excellent opportunity to gain hands-on experience in compliance and quality-driven pharmacovigilance work within a global life sciences organization, with visibility into audits, inspections, and cross-regional collaboration.

We are an equal opportunities Recruitment Business and Agency, welcoming applications from all suitably qualified candidates regardless of race, sex, disability, religion/belief, sexual orientation, or age.

For more information, visit www.planet-pharma.com.