Senior Drug Safety Specialist

We are seeking a highly skilled Senior Drug Safety Specialist to support global pharmacovigilance activities within a leading healthcare organization. The ideal candidate has a strong background in clinical practice (bedside/hospital experience) and hands-on exposure to drug safety, pharmacovigilance, or clinical research environments.

This role plays a critical part in ensuring patient safety, regulatory compliance, and high-quality safety reporting across global markets.

• Process and evaluate adverse event reports (ICSRs) in accordance with global PV regulations
• Perform case intake, triage, assessment, and documentation of safety data
• Conduct medical review and safety signal evaluation support
• Ensure compliance with global regulatory requirements (FDA, EMA, ICH guidelines)
• Support preparation of safety reports, narratives, and medical documentation
• Collaborate with clinical, regulatory, quality, and medical writing teams
• Assist in medical device complaint handling (if applicable to assigned projects)
• Participate in quality reviews, audits, and process improvement initiatives

Qualifications:

Required:

• Bachelor’s degree in Nursing, Pharmacy, Medicine, or Life Sciences
• Minimum 4–5 years experience in:
• Pharmacovigilance / Drug Safety
• Clinical Research
• Healthcare / Hospital bedside practice (required)
• Strong understanding of clinical terminology and patient care workflows
• Excellent written and verbal communication skills

Preferred:

• Experience in pharmaceutical or CRO industry
• Exposure to medical writing or safety report preparation
• Experience in medical device complaint handling
• Knowledge of ICSR processing, signal detection, or safety analysis