Senior Drug Safety Specialist – Day Shift

About the role

Join a leading provider of pharmacovigilance services supporting top pharmaceutical companies and biotechs worldwide. As a Senior Drug Safety Specialist you will lead day‑to‑day PV activities, ensuring patient safety and regulatory compliance across clinical trials.

Key responsibilities

• Perform independent PV case processing, including collection, monitoring, assessment, and tracking of safety information.
• Participate in on‑call duties to provide 24‑hour case intake coverage for specific projects.
• Lead and mentor junior staff, assisting in the development of procedural documents.
• Prepare for and attend audits, ensuring adherence to GMP and safety standards.
• Review regulatory and pharmacovigilance publications to stay current on regulations and best practices.
• Maintain therapeutic area knowledge and ensure case quality, consistency, and accuracy.
• Coordinate routine project activities such as clinical trial implementation, endpoint assessment committees, and data safety monitoring committees.

Required profile

• Bachelor’s degree or equivalent in a relevant field.
• Minimum 4 years of PV case processing experience (clinical trial or post‑marketing).
• Familiarity with Argus database.
• Strong understanding of pathophysiology and disease processes in relevant therapeutic areas.
• Excellent critical‑thinking, problem‑solving, and communication skills.
• Proficient in English, with ability to translate information when required.

Required skills

• Argus database