Positioned for Future Opportunities
Since the beginning of her career as a pharmacist in 2005 in Europe, Ioana Bolata has built extensive expertise in clinical health and drug safety, contributing to multiple facets of pharmacovigilance and clinical trial oversight. Whether working as a community and hospital pharmacist in her native Romania or transitioning her expertise to pharmacovigilance after moving to the United States in 2015, Ioana's commitment to patient safety and improving public health outcomes has consistently driven her professional growth and development.
Indeed, her drive has opened doors to clinical safety work in the Bay Area—first as a volunteer at Santa Clara County Better Health Pharmacy, then on to a clinical safety associate role at Genentech, which was followed by a drug safety associate position at Forty Seven Inc., a biotech research company dedicated to helping patients defeat their cancer. (That company was acquired by Gilead in 2020.)
At that point, Ioana had 15 years of practical experience under her belt and was ready to advance her expertise in clinical research. “The ever-evolving nature of regulations and scientific advancements keeps the work dynamic, challenging and rewarding,” she tells me. “Ultimately, knowing that my efforts can help bring safe and effective treatments to market is what drives me in this field.”
And to keep up with the changing nature of this work, she turned to a trusted educational provider to excel—UC Berkeley Extension and our Certificate Program in Clinical Research Conduct and Management.
“I chose this certificate because of the school’s strong reputation for offering high-quality, practical education,” Ioana confirms. “The certificate provided me with the foundational knowledge and skills needed to excel in clinical trials and drug development. Additionally, the flexibility of the program allowed me to balance my professional and personal commitments while advancing my expertise in this critical field.”
You were able to complete the certificate in one year. How was that experience?
Going through the classes was enriching. The curriculum is well structured, focusing on both the theoretical and practical aspects of clinical trials. The material is comprehensive, covering key areas like regulatory requirements, protocol development and clinical trial management, which has deepened my understanding of the field.
Interacting with fellow students has been rewarding—many of them come from diverse professional backgrounds, so I’ve had the opportunity to learn from their experiences, as well. The discussions and collaborative assignments have helped me see clinical trials from multiple perspectives.
The instructors have been very approachable and knowledgeable, offering real-world insights based on their industry experience. Their feedback has been invaluable in applying the concepts learned to practical scenarios, making the overall experience highly interactive and impactful.
I chose this certificate because of the school’s strong reputation for offering high-quality, practical education.
When you completed the program, you moved to a senior drug safety case manager at Cytokinetics and are now working as senior manager of global patient safety operations at Arcturus Therapeutics. How did the classwork impact these two roles?
The coursework provided a strong foundation for both roles by enhancing my ability to manage drug safety data, understand regulatory requirements and streamline case-management processes.
At Cytokinetics, this helped me advance from understanding individual safety cases to seeing the broader impact of pharmacovigilance on clinical outcomes and regulatory compliance.
In my current role as senior manager of global patient safety operations at Arcturus Therapeutics, the insights and skills from my studies have been invaluable. They have allowed me to develop and implement effective safety strategies across global programs, coordinate complex clinical trials, and improve cross-functional collaboration within safety and compliance teams. The coursework refined my skills in safety operations and strategic thinking, which are essential for the global oversight required in my position today. I’m involved in clinical trials for rare diseases, flu and COVID, overseeing pharmacovigilance vendor activities and collaborating with different departments and CROs.
I’ve been able to apply many of the lessons learned in class directly to my current work. The coursework has deepened my understanding of clinical trial regulations, safety reporting and protocol management, which are all key components of my job at Arcturus Therapeutics. For example, the knowledge I gained has been invaluable in drafting standard operating procedures (SOPs) and working instructions for my team.
Additionally, the emphasis on data management and compliance in the curriculum has helped me improve the quality and efficiency of safety case processing, especially as we transition this function in-house.
In my current role as senior manager of global patient safety operations at Arcturus Therapeutics, the insights and skills from my studies have been invaluable. They have allowed me to develop and implement effective safety strategies across global programs, coordinate complex clinical trials, and improve cross-functional collaboration within safety and compliance teams.
What does earning this certificate mean for you, personally and professionally?
On a personal level, it represents a commitment to my growth and a milestone in my journey of continuous learning. It validates my efforts to deepen my expertise and stay current in the field of clinical trials and drug safety.
Professionally, the certificate enhances my credentials and gives me greater confidence in my ability to manage complex clinical trials and safety operations. It positions me for future opportunities, allows me to take on more strategic responsibilities and helps ensure that my team adheres to the highest industry standards.
Overall, it strengthens my ability to contribute meaningfully to drug development and patient safety.
Where can we find you five to 10 years from now?
I envision myself continuing to grow within the clinical trials and drug safety field, likely in a leadership role where I can have a broader impact on patient safety and the development of innovative therapies.
I see myself overseeing larger, global teams and being more involved in strategic decision-making at a senior executive level. I also hope to contribute to shaping industry best practices, potentially mentoring the next generation of professionals.
Ultimately, I aim to be in a position where I can help drive meaningful advancements in health care on a global scale.
The certificate positions me for future opportunities, allows me to take on more strategic responsibilities and helps ensure that my team adheres to the highest industry standards.
What advice would you give to a student who is starting the certificate?
Stay organized and manage their time effectively. Here are some specific tips to help you succeed:
- Engage actively: Participate in discussions and group projects. Engaging with fellow students and instructors will enrich the learning experience and help you gain different perspectives.
- Leverage resources: Students should take advantage of all available resources, including online materials and networking opportunities. They should not hesitate to reach out to instructors for clarification or guidance.
- Apply what you learn: Connect the coursework to the current job or any practical experiences. Applying lessons in real-world scenarios will reinforce your understanding and retention.
- Network: Build relationships with peers and instructors. Networking can lead to valuable connections in the industry and potential career opportunities.
- Stay curious: Keep an open mind and stay curious about the material. Exploring topics beyond the curriculum can enhance your knowledge and fuel your passion for the field.
- Balance commitments: If working while studying, prioritize your commitments and set realistic goals to maintain a healthy work-life balance. This will help prevent burnout.
