{"id":14452,"date":"2023-12-05T07:00:00","date_gmt":"2023-12-05T12:00:00","guid":{"rendered":"https:\/\/www.ptcbio.com\/?p=14452"},"modified":"2023-12-06T07:36:21","modified_gmt":"2023-12-06T12:36:21","slug":"an-important-job-and-rewarding-career","status":"publish","type":"post","link":"https:\/\/www.ptcbio.com\/posts\/an-important-job-and-rewarding-career\/","title":{"rendered":"An Important Job and Rewarding Career"},"content":{"rendered":"\n<figure class=\"wp-block-image alignleft size-large is-resized\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.ptcbio.com\/wp-content\/uploads\/sites\/2\/2023\/09\/Calum-Sinclair-768x1024.jpg\" alt=\"Calum Sinclair\n\" class=\"wp-image-14455\" width=\"192\" height=\"256\" srcset=\"https:\/\/www.ptcbio.com\/wp-content\/uploads\/sites\/2\/2023\/09\/Calum-Sinclair-768x1024.jpg 768w, https:\/\/www.ptcbio.com\/wp-content\/uploads\/sites\/2\/2023\/09\/Calum-Sinclair-225x300.jpg 225w, https:\/\/www.ptcbio.com\/wp-content\/uploads\/sites\/2\/2023\/09\/Calum-Sinclair-400x533.jpg 400w, https:\/\/www.ptcbio.com\/wp-content\/uploads\/sites\/2\/2023\/09\/Calum-Sinclair.jpg 1104w\" sizes=\"auto, (max-width: 192px) 100vw, 192px\" \/><\/figure>\n\n\n\n<p class=\"core-block core-paragraph\">It\u2019s Calum Sinclair\u2019s job to help ensure patient safety. As the Vice President, Global Pharmacovigilance (PV) at PTC, Calum leads a global team who collect, assess, and monitor the use and safety of PTC\u2019s medicines, from clinical to commercial setting.&nbsp;&nbsp;<\/p>\n\n\n\n<p class=\"core-block core-paragraph\">It\u2019s a highly important role that Calum candidly enjoys and has throughout his extensive career in pharmacovigilance at various global pharmaceutical companies. With a degree in Cell Biology and PhD in Human Genetics, Calum truly understands and appreciates science and it\u2019s this <em>\u2018element of science\u2019 <\/em>that he says has led his 25-year career in this function.<\/p>\n\n\n\n<p class=\"core-block core-paragraph\">Along with the benefit of <strong>\u201cworking with cross functional teams\u201d<\/strong> the biggest satisfaction for Calum in the job is <strong>\u201cbeing able to help rare disease patients with medicines that are going to change the course of their disease\u201d<\/strong>.<\/p>\n\n\n\n<p class=\"core-block core-paragraph\">In honor of Patient Safety Day, Calum was kind to answer a few questions about this important function at PTC.<\/p>\n\n\n\n<p class=\"core-block core-paragraph\"><strong>Q: How do you ensure patient safety in pharmacovigilance?<\/strong><\/p>\n\n\n\n<p class=\"core-block core-paragraph\"><strong>Calum: <\/strong>There are various strategies that we use to ensure patients, healthcare providers and administrators are educated on how the treatment is supposed to be used. These include patient information leaflets in the pack, and for specific medicines preparation of educational materials about drug administration and pharmacy manuals about drug preparation. It is important to continue to monitor how treatments are used after approval. It allows us to understand the treatment in a broader population. We ensure that there are processes in place to record any and all potential feedback from patients and physicians on the treatment.<\/p>\n\n\n\n<p class=\"core-block core-paragraph\"><strong>Q: Is pharmacovigilance different when you&#8217;re working in the rare disease space?<\/strong><\/p>\n\n\n\n<p class=\"core-block core-paragraph\"><strong>Calum: <\/strong>Yes, pharmacovigilance is different in rare diseases. If you\u2019re treating a disease where you only have a small number of patients worldwide, it becomes harder to evaluate the risks, so a lot of efforts are in the post marketing domain. More information is collected through registries and real-world studies. These registries which can go on for 10, even 20 years, become really important for patient safety.<\/p>\n\n\n\n<p class=\"core-block core-paragraph\"><strong>Q: What is the overall impact of pharmacovigilance?&nbsp;<\/strong><\/p>\n\n\n\n<p class=\"core-block core-paragraph\"><strong>Calum: <\/strong>Pharmacovigilance activities help enhance patient safety by making sure that patients receive the safest and most effective care possible.<\/p>\n\n\n\n<p class=\"core-block core-paragraph\"><strong>Q: How does PTC pharmacovigilance stay ahead of emerging needs and innovations?\u00a0<\/strong><\/p>\n\n\n\n<p class=\"core-block core-paragraph\"><strong>Calum: <\/strong>Pharmacovigilance is evolving as drug development companies continue to bring novel products to patients. &nbsp;Rare disease is a particularly innovative space and regulations around new and advanced therapies are evolving. At PTC, we continually adapt to keep up with regulations when it comes to monitoring the safety of therapies both in trials and in the real world. This can include changing processes in response to updated guidelines on risk management of advanced therapy medicinal products, implementing new technologies to detect and report adverse drug reactions. &nbsp;&nbsp;&nbsp;<\/p>\n\n\n\n<p class=\"core-block core-paragraph\"><strong>Q: What is unique about PTC\u2019s pharmacovigilance team and business function?<\/strong><\/p>\n\n\n\n<p class=\"core-block core-paragraph\"><strong>Calum: <\/strong>In pharmacovigilance, we do have a lot of regulations we need to meet but everyone is able to make an impact. People come in with bright new ideas and bring experiences that have been tried and tested before and they help improve things and contribute to continuous innovation in our business function.<\/p>\n\n\n\n<p class=\"core-block core-paragraph\">We are also a global team and are exposed to cross cultural and cross functional collaboration every day which brings a great deal of diversity into our work and provides continuous learning experiences. &nbsp;<\/p>\n\n\n\n<p class=\"core-block core-paragraph\">Thank you, Calum!<\/p>\n","protected":false},"excerpt":{"rendered":"<p>It\u2019s Calum Sinclair\u2019s job to help ensure patient safety. As the Vice President, Global Pharmacovigilance (PV) at PTC, Calum leads a global team who collect, assess, and monitor the use and safety of PTC\u2019s medicines, from clinical to commercial setting.&nbsp;&nbsp; It\u2019s a highly important role that Calum candidly enjoys and has throughout his extensive career&hellip;<\/p>\n","protected":false},"author":2,"featured_media":14457,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[11],"tags":[],"media-type":[5],"therapeutic-area":[],"class_list":["post-14452","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-science-and-innovation"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>An Important Job and Rewarding Career - PTC Therapeutics (United States)<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.ptcbio.com\/posts\/an-important-job-and-rewarding-career\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"An Important Job and Rewarding Career\" \/>\n<meta property=\"og:description\" content=\"It\u2019s Calum Sinclair\u2019s job to help ensure patient safety. 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