Drug Safety Specialist (Night Shift)

About the role

We are looking for a Night‑Shift Drug Safety Specialist to join our expert pharmacovigilance team. You will work in an office environment, supporting clinical trials for leading pharmaceutical and biotech companies by ensuring timely and accurate safety data handling.

Key responsibilities

• Perform day‑to‑day PV activities including data entry, coding, case review, follow‑up, and regulatory reporting.
• Participate in on‑call duties to provide 24‑hour coverage for adverse event intake.
• Review pharmacovigilance publications and stay current with regulations and best practices.
• Maintain medical understanding of therapeutic areas and disease states relevant to the projects.
• Ensure case quality, consistency, and accuracy, including peer‑review verification.
• Prepare and maintain regulatory safety reports.
• Assist with project implementation, presentations at client/investigator meetings, and budget/metric reviews.
• Mentor less experienced staff members.

Required profile

• Bachelor’s degree or equivalent in a relevant field.
• Minimum 2 years of experience in pharmacovigilance or related safety activities.
• Strong understanding of pathophysiology and disease processes.
• Excellent critical‑thinking and problem‑solving abilities.
• Effective oral and written communication skills in English.
• Ability to translate safety information into local languages when required.
• Computer literacy with experience using multiple databases.

Required skills

• Adverse Event (AE) coding
• Regulatory safety reporting
• Clinical trial data entry
• Database management