Flourish Research

Senior Pharmacovigilance Specialist – Safety Data & Regulatory Excellence

Join EXTEDO Pharmacovigilance, a globally recognized leader in pharmacovigilance and safety data management, as we drive innovation and compliance in the pharmaceutical industry. In this pivotal role, you will contribute to the strategic oversight of safety data, ensuring rigorous regulatory adherence while supporting the development and commercialization of life-changing therapies.

As a key member of our dynamic team, you will leverage your expertise in pharmacovigilance to monitor, analyze, and manage critical safety information with precision. Your work will directly impact patient safety, regulatory decision-making, and the integrity of global clinical programs. With a global footprint, EXTEDO offers unparalleled opportunities to collaborate with cross-functional teams, regulatory bodies, and international stakeholders to shape the future of pharmaceutical safety.

In this position, you will:

• Lead and oversee safety data management to ensure compliance with international regulatory standards, including ICH-GVP, FDA, EMA, and other global guidelines.
• Develop and implement robust pharmacovigilance processes, including signal detection, risk assessment, and periodic safety update reports (PSURs).
• Collaborate with clinical, medical, and regulatory affairs teams to interpret safety data, mitigate risks, and align strategies with global market requirements.
• Drive data-driven decision-making by analyzing adverse event reports (AERs), conducting root cause analyses, and contributing to regulatory submissions.
• Stay at the forefront of industry trends, ensuring EXTEDO remains a leader in pharmacovigilance innovation and compliance.
• Support global initiatives by working with international teams to harmonize safety reporting, regulatory interactions, and crisis management protocols.

If you are a detail-oriented professional with a passion for patient safety and regulatory excellence, we invite you to be part of EXTEDO’s mission. Your expertise will not only enhance our operational efficiency but also contribute to the trust and reliability of pharmaceutical products worldwide.

Join us in making a meaningful impact on global health—where precision, integrity, and collaboration define success.