Innovation and the Future of Pharmacovigilance

• Co-Founders End of Year Extravaganza II

  Send us a textUnlock the potential of the future in pharmacovigilance as we chart the transformative journey of the industry in 2024 and beyond. Discover how smaller companies are spearheading innovation by filling niche gaps, while larger players focus on comprehensive platform-level needs. Witness this dynamic balance creating a fertile environment for both cutting-edge solutions and agile advancements. Gain insights into the evolving role of AI, as we transition from an AI-led to an AI-assisted world, where human expertise continues to steer complex processes such as case management.As we navigate the rapid technological advancements in the pharmaceutical landscape, we explore touchless case processing and the intricacies of integrating regulatory and safety databases. The episode sheds light on the challenges of aligning cutting-edge technology with business needs and the burgeoning curiosity about peer strategies in tech adoption. Our discussion emphasizes the need for standardized processes in business development, highlighting creative strategies like mergers, acquisitions, and partnerships that aim to streamline pharmacovigilance activities and enhance scalability.Celebrate the accomplishments and resilience of our younger colleagues and the Truliant team as we share key moments of pride from 2024. From executing successful safety summits to crafting significant proposals, the dedication of our team shines through. We offer career advice, stressing the importance of flexibility and adaptability in a rapidly evolving regulatory landscape. Join us as we honor the legacies of Tony DeSouza and Alan Hochberg, and look ahead to a future where innovation thrives through continuous learning and collaboration.

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• Marie Pihl

  Send us a textMarie Pihl’s journey from an assistant nurse with dreams of working in a children's hospital to becoming the Director of Operations, Technology, and Analytics in Global Patient Safety at AstraZeneca is nothing short of inspiring. Her story is one of perseverance, adaptability, and the power of commitment, as she balanced further education in molecular biology while raising three children. Marie's 21-year career at AstraZeneca, marked by pivotal experiences like training a vendor team in Budapest, showcases the transformative potential of embracing challenges and seizing opportunities.Join us as we explore the shifting dynamics of career development in the pharmaceutical industry. With traditional linear career paths being reimagined, the importance of gaining broad experience and embracing lateral moves is more crucial than ever. We'll discuss how fostering a collaborative and open team environment can lead to immense growth and innovation, and the role social media plays in shaping career expectations. This episode also delves into the need for cross-functional understanding at organizations like AstraZeneca to ensure cohesive progress across various expert areas.Finally, we uncover AstraZeneca’s strategic approach to vendor collaboration and oversight, emphasizing the balance between strategic control and operational efficiency. Through the analogy of a garden, we explore the continuous care required in pharmacovigilance and the cautious optimism surrounding the integration of automation and AI. Listen in for insights on maintaining adaptability, learning from setbacks, and the critical role human oversight plays in technological advancements, as we ponder the future landscape of pharmacovigilance.

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• Thomas Kuckuk

  Send us a textWhat can we learn from a leader at the forefront of pharmacovigilance and risk management? Thomas Kuckuk, Head of System Operations Management at Novartis, offers an insightful journey through his career, weaving through medical informatics and into the heart of the pharmaceutical industry. This episode promises to illuminate the dynamics of safety technology and strategic program implementation, highlighting the critical differences between development and commercial settings that have shaped his professional path.We delve into the world of AI, exploring its revolutionary role in safety technology and distinguishing between genuine AI applications and basic automation. The conversation sheds light on the pressing challenges of scaling AI solutions within large corporations and the fragmented software vendor landscape. Insights from the World Drug Safety Congress underscore the urgent need for innovation, steering away from the redundant reinvention of existing solutions, and pushing for a unified approach that truly adds business value.Thomas and I also tackle the potential of industry-wide collaboration, especially in the context of cloud-based vendor landscapes. We discuss the impact of vendor lock-in on innovation and the promising avenues of adopting standardized data models to foster a competitive environment. By encouraging collaboration and balancing market forces, we aim to enhance patient safety and efficiency, unlocking new possibilities for both large and small players in the pharmaceutical world. Join us for a thought-provoking session that explores the potential of driving innovation through strategic industry partnerships.

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• Sabura Matthews

  Send us a textSabura Matthews, a visionary in digital strategy for global patient safety, shares her transformative journey from the fast-paced world of trauma nursing to the strategic realm of pharmacovigilance. Her story begins amidst the chaotic energy of Philadelphia's trauma centers, where she honed her critical care skills. Facing professional challenges and yearning for growth, Sabura transitioned into clinical data management at SmithKline Beecham, where she discovered the powerful intersection of technology and patient safety. Her evolution serves as an inspiring blueprint for those looking to pivot their careers while leveraging their unique expertise.Listeners will gain insights into the dynamic nature of pharmacovigilance careers as we dissect the shifting landscape over the years. The rise of AI and the prevalence of vendor outsourcing have redefined opportunities, particularly in roles focused on case processing. Sabura shares valuable strategies for career development, emphasizing the importance of proactive learning. From attending industry events to consuming educational content, she highlights the need to continuously expand one's skill set. This episode promises actionable advice for anyone eager to navigate and succeed in an ever-evolving industry.We also explore the complexities of project management and the critical role of digital tools in enhancing operational efficiency. The conversation dives into the nuances of balancing outsourcing with maintaining control over essential processes, stressing the danger of excessive dependence on vendors. Sabura's insights offer a guide to optimizing internal operations and ensuring compliance with the latest regulatory and technological standards. Listen to this enriching dialogue for thoughtful perspectives on aligning digital solutions with business needs, fostering strong vendor relationships, and ultimately achieving successful project outcomes.

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• Sibel Guerler

  Send us a textWhat do you get when you combine a background in neurobiology with a serendipitous introduction to pharmacovigilance? Join us as Sibel Guerler, Head of Strategy and Safety Evaluation at BMS, takes us on her remarkable journey, where life's unexpected turns have led to a fulfilling career in drug safety. Transitioning from managing databases and hard copies to embracing cutting-edge technologies, Sibel’s story is a testament to adaptability and the power of seizing opportunities. Her insights offer a compelling look at how passion and a supportive environment can transform a career into a calling.Explore the highs and lows of working within large organizations like J&J, as Sibel recounts her early days of navigating complex structures and learning from seasoned mentors. From establishing an oversight group to managing diverse responsibilities in smaller markets, her experiences illuminate the intricate world of pharmacovigilance and the importance of cultivating leadership skills. The episode unfolds with her transition to Celgene, where her enthusiasm for technological innovation reshaped her professional path, showcasing the dynamic evolution of roles in safety management.As Sibel reflects on the broader shifts in pharmacovigilance over the last two decades, we uncover the impact of pivotal FDA and EMA legislations and the pressing need for modern, agile approaches to safety. With a focus on integrating safety considerations into digital health ideation, she challenges outdated frameworks and highlights the strategic role of safety teams in the competitive landscape of drug development.

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