Meet the Expert: Terry Hietpas

July 9, 2019

ProPharma Group has launched a “Meet the Expert” series to introduce you to our experts from around the world. This series will help you get to know who we are, and how our colleagues work to support clients’ complex challenges throughout the complete product lifecycle.

Meet the Expert: Terry Hietpas, Principal Pharmacovigilance Specialist

Can you tell us what you do? 

As a Principal Pharmacovigilance Specialist, I perform a variety of functions within the PV department including case report review, drafting the analysis aspect of aggregate safety reports (PADERs, PSUR/PBRERs), reviewing and analyzing specific literature-based searches for clients for regulatory purposes (e.g., product approval, annual reports, labeling changes associated with pregnancy and lactation), suggesting and developing conventions for case assessment, and developing client-specific working practices. I am also involved in signal detection within the PV department as well as regulatory intelligence. I assist in training of new personnel and work with pharmacy students as part of experiential education.

What do you like best about working with clients? 

I really enjoy the process of getting to know a client’s personnel, products, and perspective on product safety in its various dimensions (regulatory, quality, pharmacology, etc.). While ProPharma Group has a well-established PV operation, most clients have unique needs or preferences based on its products, internal operations, post-marketing requirements or identified safety/stewardship concerns, and its own experience within the industry, that augment that operation in some way.

On the flip side, ProPharma Group offers rich experience gained through client and agency interaction for almost two decades – we can draw upon and offer solutions we’ve found or learned of through other clients. We also are continually scanning the horizon for emerging pharmacovigilance or regulatory requirements that need to be incorporated into our working agreements, working collaboratively with clients in finding the best “fit.” The process of establishing and then delivering on the best operational “fit” (alignment) for each client is what I like best. I serve as the point-person (client lead) for a number of clients - work which I find interesting and rewarding.

What's one lesson you've learned in this industry that's stuck with you? 

I’ve learned that pharmacovigilance is both an art and a science. To the untrained eye, pharmacovigilance looks like information shuffling for the purpose of regulatory compliance --- in reality, however, it operates at an exciting intersection of various lines of knowledge – basic science, clinical science, epidemiology, quality standards and concepts, regulatory intelligence, etc. – with the bottom-line purpose of maximizing safe use of drugs, supplements, or devices.

A fundamental piece of the process is ultimately determining if a pattern seen in the experience of consumers is causally related to a product or not – reaching the best answer based on information available at any one time is where the art and science of analysis and interpretation are equally necessary.

What do you like to do in your free time? 

My main free time activities (scattered over the course of a year) are long-distance running (half-marathon or less these days), playing all forms of percussion with church or family groups, and developing and tending to various perennial gardens at my home. I read a lot and like to stay up on the matters of the world.

Why are you proud to work at ProPharma Group? 

I am proud to work at ProPharma Group because I know the depth of knowledge, character, and commitment to quality and client satisfaction my colleagues bring with them to work every day. Over the last 15 years, I’ve been proud to watch us expand to offer services across the entire product life cycle and across the globe in a measured, deliberate way, keeping quality and client satisfaction at the fore – I’m very proud to have been (and be) a part of those services with the bottom-line purpose of maximizing safe use of drugs, supplements, or devices.


April 13, 2023

EMA’s Regulatory Science Strategy to 2025 is on Track

Key messages from the mid-point achievements report To strengthen regulatory and scientific support for innovative medicines and diagnostics development, in March 2020 EMA published its Regulatory...

Read the Full Article

December 8, 2020

A Guide to the Clinical Study Report

What is a Clinical Study Report? A Clinical Study Report (CSR) is a document that describes the methods and results of a clinical study or trial, along with a short discussion of key findings related...

Read the Full Article
Quality & Compliance GMP

December 16, 2015

The FDA’s Enforcement of Section 503B of the Federal Food, Drug, and Cosmetic Act

The FDA publishes weekly enforcement reports highlighting drugs that have been recalled during the previous week. Over the past several months these reports have been littered with hundreds of...

Read the Full Article