Summary:
In this enlightening interview with Stefania De Santis, Director of Pharmacovigilance at seQure, we uncover the journey of a seasoned professional who transitioned from medical marketing to leading a top-notch pharmacovigilance team. Stefania shares insights into her daily responsibilities, her career evolution, and the passion that drives her work in drug safety. With over 30 years of experience, she discusses the challenges and rewards of building a team, the importance of regulatory understanding, and her unique blend of professional dedication and personal interests.
Key Concepts:
- Role and Responsibilities:
- Supervises pharmacovigilance activities at seQure, including team management and quality delivery.
- Engages in senior-level tasks such as signal detection and medical writing.
- Acts as QPPV (Qualified Person Responsible for Pharmacovigilance) for certain clients, bearing personal legal responsibility.
- Career Path:
- Started in medical marketing and transitioned to pharmacovigilance following regulatory changes.
- Accumulated extensive experience in large pharma before moving to consultancy at seQure.
- Achievements:
- Successfully built and led pharmacovigilance teams from scratch.
- Emphasises the importance of teamwork and shared passion in achieving excellence.
- Inspirations and Motivations:
- Finds motivation in the regulatory environment and the role of pharmacovigilance in patient safety.
- Believes in the value of applying regulations effectively to benefit patients.
- Advice for Early Career Specialists:
- Gain diverse business experience by working in both pharmaceutical and consultancy settings.
- Maintain humility and continuously seek new knowledge and competencies.
- Personal Values and Interests:
- Dedicated to delivering high-quality work and finding personal satisfaction in her role.
- Enjoys yoga, singing in a choir, and pursuing botany, reflecting a balance between professional and personal passions.
What aspects of pharmacovigilance intrigue you the most, and how do you think understanding the role of professionals like Stefania De Santis can shape your approach to pursuing a career in this field?