January 22, 2024

Senior Wisdom, Fresh Perspective: A Q&A with PiVOT’s Regulatory and Pharmacovigilance Duo


Regulatory Affairs in the Philippines: Navigating the Landscape with PiVOT

The Philippines is a rapidly growing market for clinical research, and with that growth comes an increasing demand for qualified professionals in regulatory affairs and pharmacovigilance (PV). These two essential disciplines play a critical role in ensuring the safety and efficacy of new drugs and medical devices, and they offer exciting career opportunities for those with the right skills and knowledge.

Challenges and Opportunities in the Philippines

The regulatory landscape in the Philippines is complex and ever-changing, presenting both challenges and opportunities for those working in RA and PV. On the one hand, the Philippines Food and Drug Administration (FDA) has implemented strict regulations to ensure the safety of drugs and medical devices. This means that RA and PV professionals need to have a deep understanding of the relevant regulations and guidelines. On the other hand, the Philippines FDA is also committed to supporting clinical research, and this has led to the development of a number of innovative programs and initiatives. This presents a great opportunity for RA and PV professionals to get involved in cutting-edge research and development.

PiVOT: A Leader in Regulatory Affairs and Pharmacovigilance

PiVOT is a leading Philippine CRO that provides a full range of RA and PV services to the pharmaceutical and medical device industries. The company has a team of experienced professionals who are well-versed in the latest regulations and guidelines. PiVOT is also committed to providing its employees with the training and development they need to excel in their careers.

A Q&A with PiVOT’s Regulatory and Pharmacovigilance Duo

To get a better understanding of the challenges and opportunities facing RA and PV professionals in the Philippines, we spoke with two members of PiVOT’s regulatory and pharmacovigilance team: Kelvin Cometa, a Senior Regulatory and PV Associate, and Eliza Ang, a recent graduate and new recruit.

In this Q&A, they share their insights on work-life balance, career advice, and the importance of mentorship in PiVOT’s supportive team culture.

Kelvin Cometa: A Seasoned Expert

How do you manage work-life balance in a demanding field like regulatory affairs?

At PiVOT, a supportive team culture is a blessing. But I also actively manage my workload by setting realistic goals, prioritizing effectively, and communicating openly with the team. Setting clear boundaries and occasionally delegating tasks helps prevent burnout. These personal strategies, combined with the team’s commitment to work-life balance, make this demanding field much more sustainable for me.

What advice would you give to someone like Eliza starting their career in Regulatory Affairs or Pharmacovigilance?

Starting a career in RA is both exciting and challenging. Here are three key pieces of advice I wish I had known when I began in the Regulatory Affairs field:

1) Build a Strong Regulatory Foundation

Invest time in understanding the fundamentals of RA, including regulations, guidelines, and industry standards. Stay updated on regulatory changes that can significantly impact your work.

2) Embrace Continuous Learning

The regulatory landscape is dynamic, so commitment to continuous learning is essential. Stay abreast of industry developments and adapt to ever-changing regulations.

3) Attention to Detail

RA work involves meticulous attention to detail. Scrutinize documentation, submissions, and compliance requirements to avoid errors with serious consequences.

How do you see the role of mentors and senior associates in promoting learning and development within PiVOT?

Mentors and senior associates play a vital role in fostering a culture of learning and development at PiVOT. Their guidance, expertise, and dedication to the growth of junior associates contribute significantly to our overall success and sustainability. They provide valuable insights, share best practices, and offer support that empowers junior associates to excel and reach their full potential.

Eliza Ang: A Fresh Perspective

What attracted you to PiVOT and the role of Regulatory/PV Associate?

I was initially drawn to PiVOT as an intern, where I discovered the diverse clinical research roles available for pharmacists. This exposure ignited my passion for regulatory affairs and pharmacovigilance. What attracted me to the role of Regulatory/PV Associate at PiVOT is the organization’s commitment to innovation and its dynamic approach to advancing healthcare through stringent regulatory compliance and robust pharmacovigilance practices. Joining PiVOT aligns perfectly with my career aspirations, providing a platform for meaningful contributions to regulatory processes and drug safety within a collaborative and growth-oriented environment.

How has PiVOT supported your learning and development as a new graduate?

PiVOT has been instrumental in supporting my learning and development as a new graduate in several ways. Firstly, they sponsored my attendance at the PCRP General Assembly, providing me with exposure to the latest industry trends and networking opportunities.

Moreover, PiVOT has consistently invested in my professional growth by sending me to various specialized training sessions. These trainings have not only broadened my knowledge but have also offered valuable insights that directly contribute to my career development as a Regulatory/PV Associate.

Equally significant has been the guidance from my seniors in the department. Their mentorship has allowed me to glean practical lessons and navigate the nuances of the regulatory and pharmacovigilance landscape. Their encouragement to continually learn and adapt for the sake of my career has been invaluable, fostering an environment where continuous improvement is not just encouraged but embraced. PiVOT’s commitment to my learning journey has played a pivotal role in shaping my capabilities for success in my role as a Regulatory/PV Associate.

What advice would you give to students or recent graduates interested in a career in Regulatory Affairs or Pharmacovigilance?

My advice for students/recent grads interested in Regulatory Affairs or Pharmacovigilance is to first embrace a mindset of continuous learning. Immersing myself in workshops, webinars, and conferences greatly expanded my knowledge base on pharmaceutical regulations, guidelines, and the industry as a whole. Secondly, keen attention to detail is essential, as even small errors can have significant consequences in this field. Thirdly, the regulatory landscape is subject to change. Therefore, we must develop adaptability and resilience to navigate through evolving regulations and industry requirements. Lastly, prioritize developing soft skills like effective communication and adaptability. In regulatory affairs and pharmacovigilance, these skills are invaluable for navigating complex regulations and prioritizing patient safety, setting you on a path to success in your career journey.

The Philippines is a promising market for RA and PV professionals. With its growing clinical research industry and commitment to supporting innovation, the Philippines offers a wealth of opportunities for those with the right skills and knowledge. PiVOT is a leading CRO that is well-positioned to help RA and PV professionals succeed in this dynamic field.

To learn more about PiVOT and its Regulatory and Pharmacovigilance services, click here.

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