Drug Safety Specialist (FSP) – Day Shift

About the role

Join a leading team that supports top pharmaceutical companies and biotech firms in delivering safe, effective therapies. As a Drug Safety Specialist (FSP) on the day shift, you will manage daily pharmacovigilance activities in a highly regulated environment, ensuring patient safety and compliance with GMP standards.

Key responsibilities

• Perform day‑to‑day PV tasks including data entry, coding, adverse event assessment, case review, follow‑up, and regulatory reporting.
• Participate in on‑call duties for specific projects to provide 24‑hour case intake coverage.
• Review pharmacovigilance publications and regulatory updates to stay current on guidelines.
• Maintain medical knowledge of therapeutic areas and disease states relevant to assigned projects.
• Ensure case quality, consistency, and accuracy through peer review.
• Prepare and maintain regulatory safety reports.
• Assist with project implementation, presentations at client/investigator meetings, and budget/metric reviews.
• Mentor junior staff and support audit preparation.

Required profile

• Bachelor’s degree or equivalent in a relevant field.
• Minimum 2 years of experience in PV case processing, triage, or peer review.
• Strong understanding of pathophysiology and disease processes.
• Excellent critical‑thinking and problem‑solving abilities.
• Effective oral and written communication skills in English.

Required skills

• Pharmacovigilance case processing
• Adverse event coding
• Regulatory safety reporting
• Good Manufacturing Practices (GMP) compliance