Pharmacovigilance Specialist (Remote, US)

About the role

Worldwide Clinical Trials is seeking a remote Pharmacovigilance Specialist to support US‑based studies. You will be responsible for the end‑to‑end handling of Serious Adverse Event (SAE) data, ensuring compliance with regulatory guidelines and internal SOPs.

Key responsibilities

• Collect, process, evaluate, and report incoming SAE data according to applicable regulations and project‑specific instructions.
• Author Safety Management Plans for assigned studies.
• Review SAE submissions for completeness and accuracy, perform data entry in the safety database, and track incoming safety information.
• Generate queries for missing or unclear data and follow up with sites to resolve issues.
• Conduct quality control of SAE entries processed by other PV associates.
• Prepare regulatory reports and support safety submissions as required.

Required profile

• Bachelor’s degree in a science‑related field, nursing, or equivalent.
• Minimum of 1 year of pharmacovigilance experience.
• Strong understanding of medical and scientific terminology, clinical assessment of adverse drug events, and international reporting requirements.
• Excellent organizational skills with the ability to manage multiple priorities under tight timelines.
• Positive attitude, professional communication, and ability to work collaboratively in a global environment.

Required skills

• Proficiency with relational database systems and data extraction.
• Experience using safety databases for adverse event reporting.

What we offer

• Opportunity to work remotely for a global CRO with a diverse, inclusive culture.
• Engagement in innovative clinical research projects that impact patient lives.