Pharmacovigilance Clinical Trial Specialist – Remote US Shift

About the role

We are seeking an experienced Pharmacovigilance professional to join our remote team supporting a US‑based life‑sciences client. The role focuses on clinical trial case processing, data entry, and peer review, ensuring high‑quality safety reporting across multiple clinical safety databases.

Key responsibilities

• Process and review clinical trial safety cases, including linking, duplicate handling, nullification, and invalid reports.
• Perform primary assessment of case validity, seriousness, causality, listedness, and expectedness.
• Maintain accurate MedDRA and WHODD coding for all adverse event reports.
• Collaborate with medical reviewers and the Drug Safety Unit to resolve discrepancies and ensure compliance with SOPs.
• Mentor and train new team members on pharmacovigilance procedures and database usage.

Required profile

• BS degree in Nursing or Pharmacy.
• Minimum 3 years of clinical trial case processing experience.
• Strong knowledge of ICH, FDA, and other international safety regulations.
• Excellent attention to detail, critical thinking, and teamwork abilities.

Required skills

• Proficiency with Arisg and Argus safety databases.
• Experience using Medidata Rave and Veeva Vault Safety.
• Expertise in MedDRA and WHODD coding.
• Solid understanding of clinical trial protocols and adverse event reporting.