Pharmacovigilance Specialist (Clinical Trials)

About the role

We are seeking a Pharmacovigilance Specialist to manage safety cases arising from clinical trials for a multinational CRO. The position is remote and operates on a night‑shift schedule, ensuring timely processing of adverse event data.

Key responsibilities

• Perform case intake, triage and data entry for adverse events, serious adverse events and SUSARs.
• Process safety cases following regulatory guidelines, study protocols and internal SOPs.
• Review source documents such as CIOMS forms, MedWatch reports, investigator communications and trial documentation.
• Conduct medical review, causality and expectedness assessments.
• Follow up with investigators or study teams to obtain missing information and ensure data completeness.
• Manage safety queries and resolve case discrepancies promptly.
• Prepare and submit expedited safety reports to regulatory authorities, ethics committees and investigators.
• Maintain accurate documentation and ensure compliance with global pharmacovigilance standards.

Required profile

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing or a related field (preferred).
• Minimum 5 years experience in pharmacovigilance, including at least 1 year focused on clinical trial safety.
• Strong understanding of adverse event, serious adverse event and SUSAR reporting requirements.
• Familiarity with global safety reporting regulations and clinical trial safety procedures.
• Experience reviewing CIOMS and MedWatch forms.
• Excellent attention to detail and ability to meet strict regulatory timelines.

Required skills

• Pharmacovigilance
• Adverse Event (AE) reporting
• Serious Adverse Event (SAE) reporting
• SUSAR reporting
• CIOMS form handling
• MedWatch report handling
• Regulatory compliance
• Clinical trial safety procedures

What we offer

• Remote work arrangement.
• Night‑shift schedule.