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Jun 23, 2017
Keya Pitts has worked in the pharmaceutical industry for more than 20 years, holding a number of positions at various companies. This lifelong interest in medicinal and physical sciences led her to Astellas in December 2014, where she is currently Executive Director of Pharmacovigilance and Clinical Quality Assurance.
We sat down with Keya to learn more about her team’s work and achievements, and what Astellas’ commitment to serving the community means to her.
What drew you to the pharmaceutical industry, and to Astellas specifically?
I have held various positions in the pharmaceutical industry for more than 20 years due to my lifelong interest in the field of medicinal and physical sciences. I began my career with Astellas in December 2014, after previously working for a number of pharmaceutical companies. What drew me to Astellas was the company’s enticing approach to research and development.
Can you explain more about your role here at Astellas?
I oversee the Pharmacovigilance Quality Assurance (PVQA) team within Clinical and Research Quality Assurance (CRQA). We oversee and host all PV-focused inspections globally. We also perform audits of the PV system, which includes internal audits, audits of affiliates globally, license partner and vendors supporting PV functions.
Additionally, in the Clinical Quality Assurance (CQA) function, within CRQA, I am responsible for quality assurance of the Pain/Infectious Disease/Immunology/Transplant therapeutic area, with a team covering this area. We represent CRQA on the study teams for all phases of Development and support submissions globally with quality reviews.
How does your team collaborate with other functions to advance the M&D strategy?
We invite other functions to meet with CRQA leadership to discuss strategic partnership opportunities and ways our functions can enhance support for one another in execution of M&D objectives and goals.
What advice would you give to others working in M&D?
Look beyond individual functional scope of responsibilities when developing a process. Establish processes that involve multiple functions for a more comprehensive workflow, as most activities require contributions from multiple departments.
What is unique about Astellas compared to other companies?
Astellas demonstrates investment in its talent. Also, our commitment to the community, beyond the work we do for patients, is impressive. Allowing full-time employees five days a year to dedicate service hours to community efforts is almost unheard of and clearly amounts to significant contributions to the populations we serve.
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