About the job

Drug Safety Associate

Location: 1 day/week in Leiden

About the Role

We're looking for a Drug Safety Associate to join a global pharmacovigilance team supporting a focused project to resolve outstanding case compliance activity. This is a project-driven assignment rather than a routine operational role — you'll be brought in to help close a backlog of root cause analyses (RCAs) tied to safety cases that were submitted late to health authorities, CROs, and business partners, and to help drive broader quality and compliance improvements.

You'll work closely with internal PV teams, Quality Assurance, Regulatory Affairs, and external CRO partners across multiple regions, so strong cross-functional communication and the ability to manage your own workload against deadlines will be key.

What You'll Do

• Perform 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
• Run weekly/bi-weekly meetings with case processing vendors to discuss and resolve open RCAs
• Attend weekly Compliance team meetings and project team calls with colleagues across regions
• Support PV and local affiliate staff before, during, and after internal audits, external Health Authority inspections, and license partner audits — including on-site support where needed
• Contribute to broader project and process improvement initiatives
• Maintain clear, timely communication across cross-functional teams, vendors, and business partners

What You'll Bring

• A completed Bachelor's degree
• Minimum 2 years' experience in Pharmacovigilance, Biotechnology, a Contract Research Organization, or a related industry — specifically in a quality assurance, data assurance, case processing, or similar role
• 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 how they fit into the broader PV system
• Awareness of 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 comfort working within a pharmacovigilance safety database or similar system
• Strong project management and stakeholder management capabilities
• Experience driving cross-functional initiatives and tracking deliverables through to completion (preferred)
• Ability to work effectively in a global, multicultural team environment
• Excellent written and verbal English communication skills
• A proactive, curious mindset — open to learning new tasks and comfortable navigating ambiguity

Why Apply

This is a great opportunity to gain hands-on exposure to compliance and quality-driven PV work within a global life sciences organization, with visibility into audits, inspections, and cross-regional collaboration.

About Planet Pharma:

Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

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

www.planet-pharma.com