Patient Safety Lead

About the role

The Patient Safety Lead will ensure compliance with AstraZeneca’s patient safety standards and local regulatory requirements in Costa Rica. This role oversees pharmacovigilance activities, drives a culture of openness, and guarantees timely reporting of adverse events.

Key responsibilities

• Ensure compliance with AstraZeneca policies, local regulations, and global pharmacovigilance standards.
• Maintain the Pharmacovigilance System Master File (PSMF) and keep all safety‑related documentation up to date.
• Oversee safety processes, after‑hours reporting, and business continuity for patient safety activities.
• Monitor and report adverse events, manage data transfer, and coordinate with local health authorities and ethics committees.

Required profile

• University degree or equivalent with proven competence in drug safety or regulatory affairs.
• Excellent knowledge of local legislation and international guidelines (ICH, GCP, GVP).
• Advanced English skills and strong organizational, analytical, and communication abilities.

Required skills

• Good knowledge of international guidelines ICH/GCP/GVP.
• Basic knowledge of GMP/GDP.
• Experience with Global Tracking Tool and JASPER (or similar pharmacovigilance systems).