Pharmacovigilance Coordinator – Project & Safety Support

About the role

Join a global team providing contracted project coordination and safety support for pharmaceutical and biotech programs. As a Pharmacovigilance (PV) Coordinator you will manage adverse event documentation, protocol inquiries, and safety monitoring activities across domestic and international studies.

Key responsibilities

• Coordinate timely review of protocol inquiries, serious and non‑serious adverse events, diagnostics and Data Safety Monitoring Board (DSMB) data.
• Generate and distribute reports for clients, project teams and external vendors.
• Represent the organization at DSMB/EAC meetings, handling logistics and facilitation.
• Prepare Confidentiality Disclosure Agreements, Letters of Intent and Member Agreements, ensuring contractual accuracy.
• Compile adjudication dossiers, submit follow‑up to investigative sites, and manage meeting minutes and materials.
• Maintain training records, set‑up and archive program files to keep PV audit‑ready.
• Redact subject identifiers, retrain sites, and escalate privacy issues.
• Enter data into internal/external databases, perform system reconciliations, and monitor budget parameters.
• Oversee expenses, manage translations, answer hotline calls and support local office activities.
• Provide training and mentorship to junior staff.

Required profile

• High school diploma or equivalent with relevant academic background.
• Experience in pharmacovigilance coordination, clinical safety, or related regulatory support.
• Strong attention to detail and ability to manage multiple stakeholders.

Required skills

• Data entry and management in safety databases.
• Budget tracking and expense oversight.
• Preparation of contractual and confidentiality documents.
• Coordination of DSMB/EAC meetings and related logistics.

What we offer

• Opportunity to work on global clinical trials spanning 100+ countries.
• Collaboration with experienced safety specialists and medical monitors.
• Professional development in a fast‑growing, innovative environment.