Who am I ?

Emeline Pierre Regulatory excellence, Pharmacovigilance, Tailored, Compliance, PV Quality Assurance

I am Emeline Pierre, a dedicated and highly experienced freelance Pharmacovigilance (PV) and PV Quality Assurance (PVQA) consultant, based in Belgium. With over a decade of experience in the pharmaceutical and biotechnology sectors, I specialize in providing tailored PV solutions to pharma companies, ensuring compliance with local and global regulations. I offer a range of services, including independent PV audits, inspection readiness support, and the role of Local Contact Person for PV in Belgium and Luxembourg.

My background?

I obtained by master’s degree in Pharmacology in 2010 and since then, I have been navigating in the complex world of Pharmacovigilance across various aspects of PV. From clinical safety to post-marketing pharmacovigilance and from bigger pharma companies to smaller Contract Research Organization (CRO), I learnt how to adapt to each company size, complexity and priorities. Throughout my career, I’ve worked with industry leaders like UCB, Bristol Myers Squibb, GSK Vaccines, and Eumedica where I supported global or local pharmacovigilance initiatives and conducted audits to improve safety systems.

What can I bring to you?

After 12 years of life as an employee, I realised it was time to take the leap and hop aboard the thrilling train of freelancing. I now apply my pharmacovigilance expertise in a variety of projects and clients, while supporting them with regulatory compliance and quality management. One of the services I provide is the Local Contact Person role for Pharmacovigilance in Belgium and Luxembourg. I also provide specialized training to non-PV staff on safety reporting obligations, ensuring a thorough understanding of pharmacovigilance principles across all departments and helping to create the cooperative mindset in non-PV departments. Whether assisting with audit preparation, conducting mock inspections, or driving root cause analysis and CAPA development, my goal is always to support clients in achieving regulatory excellence and maintaining the highest standards of patient safety.

How do I stay ahead in PV Excellence ?

As a commitment to continuous learning, I stay at the forefront of evolving regulations and industry best practices through different means, including:

  • Periodic in-depth PV Regulatory Intelligence across local and global sources of information
  • Strong international network of PV professionals as well as other professionals in the related fields of expertise (Regulatory affairs, Medical information, Safety systems experts …)
  • Regular attendance to congresses and workshops
  • Drawing valuable lessons from the inspections I attended 

English - C1 | French - Native | Spanish - B1 | German -A2

Colibir's values

Integrity

Transparency and honesty drive all operations. Colibir ensures full adherence to regulatory standards and ethical practices in every service provided.

Expertise

Colibir is built on deep, specialized knowledge in pharmacovigilance, ensuring the highest standard of safety and compliance for clients.

Collaboration

Building long-lasting relationship with clients based on trust and mutual respect

Adaptability

The focus is always on the client’s unique needs, ensuring personalized and flexible solutions that directly address their goals.

What people say about Colibir

Don’t just take my word for it. Here’s what my clients think about our collaborations.

"Emeline has played a vital role as safety lead in one of our affiliates, to cover for a long-term leave. With her extensive knowledge, Emeline quickly became acquainted with our PV system, and was able to fulfill all expectations of her role with ease. Emeline has the ability to proactively identify opportunities and take ownership of finding solutions, just as well as effectively and efficiently solve tasks that she is delegated. We have worked with Emeline for two years, and when a need arose for a contractor for a second time, continuation of the collaboration with Emeline was the clear first choice. I cannot but recommend Emeline, not only for her professional prowess, but also for her pleasant being and her contribution to the team’s dynamics."

Morten Mevaag, PV Country Cluster Lead, International Patient Safety, Roche

"Emeline stands out as a consummate professional with deep knowledge and expertise. I had the pleasure of hiring her as a consultant for audits at my previous company, and she truly exceeded our expectations on both occasions in her role as a GVP/GCP auditor. Emeline was not only approachable, but she also demonstrated remarkable flexibility with her working hours to accommodate our US-based team. Her audit process was comprehensive; after completing the assessments, she delivered her findings in a clear and structured manner. Beyond the typical audit feedback, Emeline proactively offered valuable recommendations for improvement and ensured she addressed our team’s queries, clarifying any uncertainties we had. Her meticulous audit practices allowed our company to effectively benchmark our performance and pinpoint areas needing enhancement. Emeline’s commitment to excellence was evident throughout the audit duration, from meticulous planning all the way through to insightful final feedback and reporting. I could not be more impressed by her professionalism and dedication. I wholeheartedly recommend her services and would welcome the opportunity to work with her again without hesitation."

Kim Garvin, Associate Director, PV Quality and Compliance, Summit Therapeutics

"We are grateful that we crossed paths with Emeline, her expertise has been invaluable for us and our clients. She quickly became our “go to” person for PV"

Ludovic Moulin, Managing Director, ObelysQ

Clients

Let’s work together !