The demographic, symptom, environment, and diagnostic test information was included in the questionnaire. document.getElementById( "ak_js_1" ).setAttribute( "value", ( new Date() ).getTime() ); Disclaimer: AIEMD.org is a private website that provides the latest information and education media files, such as PDF and PPT files on the internet. See how we connect, collaborate, and drive impact across various locations. At the Centre she conducts rigorous analysis and research to generate insights that support the practice across Life Sciences and Healthcare. Accessed May 19, 2022. Causality assessment: Review of drug (i.e. The Deloitte Centre for Health Solutions (CfHS) is the research arm of Deloittes Life Sciences and Health Care practices. For this research she received an award as best young investigator in prion diseases in UK. Operations consists of monitoring drug progress during preclinical trials as well researching real-world evidence regarding adverse effects reported by patients or healthcare professionals. Explore Deloitte University like never before through a cinematic movie trailer and films of popular locations throughout Deloitte University. Journal of comparative effectiveness research, 7(09), 855-865. translate and digitize safety case processing documents) (11). Humans are coding or programing a computer to act, reason, and learn. The .gov means its official. Many college and school students are asked to bring presentations on Artificial Intelligence especially class 10 and 12 board students. Transforming through AI-enabled engagement, The impact of AI on the clinical trial process. Multimodal Clinical Prediction Models in Research and Beyond. 1, Clinical prediction models in the COVID-19 pandemic, Move Closer to your Patients in order to Improve Recruitment, Digitalisierung im Gesundheitswesen, Teil 2, Visit here our corporate page to find out more about our, GKM Gesellschaft fr Therapieforschung mbH. View in article, Jacob Bell, Pharma is shuffling around jobs, but a skills gap threatens the process, BioPharma Dive, February 2019, accessed December 19, 2019. The AIA follows a risk-based approach. However, data availability also a common challenge in Orphan Drug trials will be essential in this context. View in article, Angie Sullivan, Clinical Trial Site Selection: Best Practices, RCRI Inc, accessed December 18, 2019. The kidney disease field routinely collects enormous amount of patient data and biospecimen, and care providers exploit this opportunity to explore the application of omics technologies with artificial intelligence for clinical use. Artificial intelligence for predicting patient outcomes Healthcare data is intricate and multi-modal . Accessed May 19, 2022, [7] https://www.globaldata.com/ Brian Martin, Head of AI, R&D Information Research, Research Fellow, AbbVie At a pivotal and challenging time for the industry, we use our research to encourage collaboration across all stakeholders, from pharmaceuticals and medical innovation, health care management and reform, to the patient and health care consumer. In the future, all stakeholders involved in the clinical trial process will align their decisions with the patients needs. Lastly, the pharmaceutical industry works on synthetic virtual control arms, meaning that the comparator group is modelled using real-world data that has previously been collected from sources such as EHR. 4. The foundation for a Smart Data Quality strategy was expanded to other TAs thanks to the solution's Pattern Recognition, Clinical Inference capabilities that will be explained in detail. However, complimentary evidence is conceivable. This site needs JavaScript to work properly. At Deloitte, our purpose is to make an impact that matters by creating trust and confidence in a more equitable society. In this context, evidence extraction is important to support translation of the . Rev. An algorithm or model is the code that tells the computer how to act, reason, and learn. Today Proc. Implicit Bias Around Advocacy and Decision Making: Metrics of DE&I and Speaking the Language of Business and Leadership. If biopharma succeeds in capitalising on AIs potential, the productivity challenges driving the decline in. Artificial Intelligence AI in Clinical Trials: Technology. This critical task is only getting more difficult as the volume of dataand the number of data sourcesgrows. Machine learning holds promise for integrating comprehensive, deep phenotypic patient profiles across time for (i) predicting outcomes, (ii) identifying patient subtypes and (iii) associated biomarkers. Disclaimer, National Library of Medicine Oculomics uses the convergence of multimodal imaging techniques and large-scale data sets to characterize macroscopic, microscopic, and molecular ophthalmic features associated with health and disease (13). 1. The widespread adoption of electronic health records (EHRs) alongside the advent of scalable clinical molecular profiling technologies has created enormous opportunities for deepening our understanding of health and disease. Below are some popular examples of Artificial Intelligence. Get the Deloitte Insights app, RCTs lack the analytical power, flexibility and speed required to develop complex new therapies that target smaller and often heterogeneous patient populations. Newell Hall, Room 202. This OPED is chilling on what can happen as the lipid nanoparticles distribute to the brain. Finally, Systems focuses on developing strong data management systems for pharmaceutical research protocols while staying compliant with all regulatory rules - an absolute necessity in this ever-changing industry! monitor conversations on social media and other platforms) (10). View in article, Stefan Harrer et al., Artificial Intelligence for Clinical Trial Design, ScienceDirect, August 2019, accessed December 18, 2019. Two recent programs, for example, combine the scoring methods of Internist . Over the past few years, biopharma companies have been able to access increasing amounts of scientific and research data from a variety of sources, known collectively as real-world data (RWD). This post provides you with a PowerPoint presentation on artificial intelligence that can be used to understand artificial intelligence basics for everyone from students to professionals. View in article, Jack Kaufman, The innovative startups improving clinical trial recruitment, enrollment, retention, and design, MobiHealthNews, November 2018, , accessed December 18, 2019. Clinical trial design: Biopharma companies are adopting a range of strategies to innovate trial design. The development of novel pharmaceuticals and biologicals through clinical trials can take more than a decade and cost billions of dollars during that tenure period View in article, Dawn Anderson et al., Digital R&D: Transforming the future of clinical development, Deloitte Insights, February 2018, accessed December 18, 2019. Come enjoy a luncheon with your peers while listening to your choice of two compelling industry presentations. The use of artificial intelligence (AI) with medical images to solve clinical problems is becoming increasingly common, and the development of new AI solutions is leading to more studies and publications using this computational technology. has been saved, Intelligent clinical trials AI in Drug Development: Opportunities and Pitfalls. Presentation Creator Create stunning presentation online in just 3 steps. The risk of lacking consistency and standards in terms of regulatory approaches; The insufficient protection of the environment; The need to address not only users but also end recipients (15). 2022;11:3. doi: 10.3390/laws11010003. Patient monitoring, medication adherence and retention: AI algorithms can help monitor and manage patients by automating data capture, digitalising standard clinical assessments and sharing data across systems. The German Federal Ministry of Food and Agriculture awarded two scientists with the 2021 Animal Welfare Research Prize for developing an automated manufacturing process of midbrain organoids. Methods A total of 168 patients from three centers were divided into training, validation, and test groups. In the future, AI, together with enhanced computer simulations and advances in personalised medicine, will lead to in silico trials, which use advanced computer modelling and simulations in the development or regulatory evaluation of a drug.12 The next decade will also see an increase in the implementation of virtual trials that leverage the capabilities of innovative digital technologies to lessen the financial and time burdens that patients incur. Applications of Machine Learning in Cardiac Electrophysiology. Brian Martin, Head of AI, R&D Information Research, Research Fellow, AbbVie, Inc. Malaikannan Sankarasubbu, Vice President, Artificial Intelligence Research, Saama Technologies, Inc. Jason Attanucci, Vice President and General Manager, Life Sciences, Deep 6 AI, Lucas Glass, Vice President,Analytics Center of Excellence, R&D Solutions, IQVIA, ukasz Kidziski, PhD, Director, AI, Clario, Janine Jones, Senior Product Manager, Clario, David Billiter, Founder and CEO, Deep Lens, Patrick Schwab, PhD, Director, Artificial Intelligence and Machine Learning, GSK. In this session, we will describe Pfizer's AI journey through the lens of clinical data, use cases, implementation and key to success. Regulatory agencies also review reports of adverse events reported by patients who have already been taking a particular medication in order to determine whether further action needs to be taken in order to better protect patients from harm. This ppt on artificial intelligence also includes types of artificial intelligence, application of artificial intelligence and its basics of it. Manual . pharmacology, pathophysiology, time overlap of event and IP administration, dechallenge and rechallenge, confounding patient-specific disease manifestations or other medications, and other explanations) to determine if certain, probable/likely, possible, unlikely, conditional/unclassified, unassessable/unclassifiable. Learn which AI-based technologies are in production for which ICSR process steps. doi: 10.1002/ams2.740. Pharmacovigilance must happen throughout the entire life cycle of a drug, from when it is first being developed to long after it has been released on the market. Artificial intelligence is the most discussed topic in the modern world and its application in all forms of businesses makes it a key factor in the industrialization and growth of economies. The drug received authorization for emergency use by the FDA in 2021 (1). Essentially, it asks does a drug work and is it safe. Artificial intelligence as an emerging technology in the current care of neurological disorders. artificial intelligence in pharmacovigilance ppt. With increasing focus on information technology and computer science, the worldwide education system focuses on including artificial intelligence in education as it creates the basis for students to create future scope in it. For the next few years, RCTs are likely to remain the gold standard for validating the efficacy and safety of new compounds in large populations. Advisory Board: For instance, IBM Healths Watson for Clinical Trial Matching aims to collect and link structured and unstructured data from Electronic Health Records (EHR), medical literature, trial information and eligibility criteria from public databases (6). Pharmaceutical companies increasingly explore AI-enabled technologies that may support in pattern recognition and segmentation of adverse events (e.g. Future of clinical development is on the verge of a major transformation due to convergence of large new digital data sources, computing power to identify clinically meaningful patterns in the. 2021 May;268(5):1623-1642. doi: 10.1007/s00415-019-09518-3. Please enable it to take advantage of the complete set of features! From technology perspective, the AI paradigm within the clinical trial planning and design can be implemented using the existing technology to process the information and make it readily available for any prediction and evaluations on the appropriateness of the trial design, given the . Simply select text and choose how to share it: Intelligent clinical trials This presentation will discuss how to implement AI in the workflow and discuss three examples where organizations have successfully done this. Monique Phillips, Global Diversity and Inclusion Lead, Bristol Myers Squibb Co. Nikhil Wagle, MD, Assistant Professor, Harvard Medical School, Dana-Farber Cancer Institute, Timothy Riely, Vice President, Clinical Data Analytics, IQVIA. Case Studies for AI-Based Intelligent Automation in Pharmacovigilance. This innovative approach allows for drug discovery in a significant shorter time compared to conventional research techniques (e.g. In Press, Journal Pre-proof. Pre-Con User Group Meetings & Hosted Workshops, Kick-Off Plenary Keynote and 6th Annual Participant Engagement Awards, Protocol Development, Feasibility, and Global Site Selection, Improving Study Start-up and Performance in Multi-Center and Decentralized Trials, Enrollment Planning and Patient Recruitment, Patient Engagement and Retention through Communities and Technology, Clinical Trial Forecasting, Budgeting and Contracting, Resource Management and Capacity Planning for Clinical Trials, Relationship and Alliance Management in Outsourced Clinical Trials, Data Technology for End-to-End Clinical Supply Management, Clinical Supply Management to Align Process, Products and Patients, Artificial Intelligence in Clinical Research, Decentralized Trials and Clinical Innovation, Sensors, Wearables and Digital Biomarkers in Clinical Trials, Leveraging Real World Data for Clinical and Observational Research, Biospecimen Operations and Vendor Partnerships, Medical Device Clinical Trial Design, and Operations, Device Trial Regulations, Quality and Data Management, Building New Clinical Programs, Teams, and Ops in Small Biopharma, Barnett Internationals Clinical Research Training Forum, SCOPE Venture, Innovation, & Partnering Conference, 250 First Avenue, Suite 300Needham, MA 02494P: 781.972.5400F: 781.972.5425 Articles 30, 43). . Social login not available on Microsoft Edge browser at this time. Costchescu B, Niculescu AG, Teleanu RI, Iliescu BF, Rdulescu M, Grumezescu AM, Dabija MG. Int J Mol Sci. A computer infographic represents the challenges of AI precisely. Maria Joao is a Research Analyst for The Centre for Health Solutions, the independent research hub of the Healthcare and Life Sciences team. Evidence for application of omics in kidney disease research is presented. Arrhythm Electrophysiol. The pharmaceutical company Roche already applied such an AI-driven model in a Phase II study (9). exploration research phase of the serotonin 5-HT1A receptor agonist DSP-1181 of less than one year) (2). She holds a BSc and MSc in Biological Engineering from IST, Lisbon. The Committee on the Environment, Public Health and Food Safety released a position paper in April 2022 with three main concerns to be addressed: Currently the AIA is under review at the Committee on the Internal Market and Consumer Protection and the Committee on Civil Liberties, Justice and Home Affairs. Before Consolidating all data whatever the source on a shared analytics platform, supported by open data standards, can foster collaboration and integration and provide insights across vital metrics. Furthermore, the early use of Watson for CTM led to an enrolment increase of 80 % in the 11 months after implementation (6). Become part of pharmaceuticals with an entry-level salary at $69K per position (in pharmacovigilance), putting you in line for higher salaries around $130k after 10+ years. Artificial Intelligence has the potential to dramatically improve the speed and accuracy of clinical trials. Getting Started in Pharmacovigilance Part 1, Coberts Manual of Pharmacovigilance and Drug Safety, Investigational product (IP): Any drug, device, therapy, or intervention after Phase I trial, Event: Any undesirable outcome (i.e. Artificial Intelligence PPT 2023 - Free Download. . 2021;4:5461. To change your privacy setting, e.g. Natural Language Understanding and Knowledge Graphs. AI-enabled technologies, having unparalleled potential to collect, organise and analyse the increasing body of data generated by clinical trials, including failed ones, can extract meaningful patterns of information to help with design. Pharmacovigilance is a vital field, with three key objectives: surveillance, operations and focus. This session explores the challenges with these processes and provides methods for automation with the use of artificial intelligence to accelerate access to downstream data consumers for quicker critical decision-making. However, in most diseases, disease-relevant markers are spread across multiple biological contexts that are observed independently with different measurement technologies and at various time schedules, and their manual interpretation is therefore in many cases complex. Post-marketing surveillance activities typically involve ongoing monitoring of drugs already available on the market in order to detect any unexpected adverse events or other issues that may not have been detected during pre-marketing tests. Biopharma companies are set to develop tailored therapies that cure diseases rather than treat symptoms. 2022 doi: 10.1016/j.tcm.2022.01.010. This letter will be emailed from the faculty directly to jenna.molen@ufl.edu by the application deadline. 3. Artificial intelligence can reduce clinical trial cycle times while improving the costs of productivity and outcomes of clinical development. Accessibility Pduraru DN, Niculescu AG, Bolocan A, Andronic O, Grumezescu AM, Brl R. Pharmaceutics. Third step is modernization in the field of wearables; Fourth step is taming big data; 2022 Aug 22;14(8):1748. doi: 10.3390/pharmaceutics14081748. CHIs 5th Annual Artificial Intelligence in Clinical Research conference is designed to facilitate the discussion and to accelerate the adoption of these approaches in clinical trials. Read our recent article about mislabeling of images in clinical trials and see how SliceVault solves this critical problem with the help of Artificial Morten Hallager on LinkedIn: #clinicaltrials #artificialintelligence #medicalimaging The conformity assessment is defined in the AIA and highlights specifically medical devices and in vitro diagnostic medical devices (ibid. View in article. Dr. Stephanie Seneff is a Senior Research Scientist at the MIT Computer Science and Artificial Intelligence Laboratory and is well-respected for her work in pre-clinical sciences. The adoption of AI technologies is therefore becoming a critical business imperative; specifically in the following six areas. Combining Automated Organoid Workflows with Artificial IntelligenceBased Analyses: Opportunities to Build a New Generation of Interdisciplinary HighThroughput Screens for Parkinsons Disease and Beyond. The PowerPoint PPT presentation: "Welcoming AI in the Clinical Research Industry" is the property of its rightful owner. Teleanu DM, Niculescu AG, Lungu II, Radu CI, Vladcenco O, Roza E, Costchescu B, Grumezescu AM, Teleanu RI. Welcome Remarks from CHI and the SCOPE Team, Thank you all for being here from the SCOPE team:Micah Lieberman, Dr. Marina Filshtinsky, Kaitlin Kelleher, Bridget Kotelly, Mary Ann Brown, Ilana Quigley, Patty Rose, Julie Kostas, and Tricia Michalovicz, Why Advancing Inclusive Research is a Moral, Scientific, and Business Imperative. As shown in the use cases AI-enabled technologies and machine learning facilitate significant breakthroughs in clinical research. Post-marketing surveillance activities also include periodic reviews of patient records related to prescribed medications in order to identify any changes or developments over time that could potentially signal an issue with a particular drugs safety profile. Organoids are an artificially grown mass of cells or tissue that resembles an organ. Pharmacovigilance is the process of monitoring the effects of drugs, both new and existing ones. Using operational data to drive AI-enabled clinical trial analytics: Trials generate immense operational data, but functional data silos and disparate systems can hinder companies from having a comprehensive view of their clinical trials portfolio over multiple global sites. 2022 Jun 9;14(12):2860. doi: 10.3390/cancers14122860. Artificial Intelligence in Medicine Market Overview PDF Guide - Artificial intelligence (AI) in medicine is used to analyze complex medical data by approximating human cognition with the help of algorithms and software. The FDA has published guidance that identifies three strategies to assist the biopharma industry to improve patient selection and optimise a drugs effectiveness, all of which could benefit from AI technologies (figure 3).4. sharing sensitive information, make sure youre on a federal Our pharmacovigilance training is sure to bolster any officer or professional's career in drug safety monitoring. View in article, Greg Reh et al., 2019 Global life sciences outlook: Focus and transform | Accelerating change in life sciences, Deloitte TTL, January 2019, accessed December 18, 2019. Post-marketing studies usually involve collecting information from healthcare professionals such as physicians, pharmacists, nurses, etc., who work directly with patients taking certain medications in order to assess their long-term safety profiles. Traditional linear and sequential clinical trials remain the accepted way to ensure the efficacy and safety of new medicines. Copy a customized link that shows your highlighted text. . Please see www.deloitte.com/about to learn more about our global network of member firms. Biomedical text mining is hard. This means that high-risk AI systems (amongst others defined as systems that pose significant risks to the health and safety or fundamental rights of persons and systems that can lead to biased results and entail discriminatory results, ibid. Letter of Support. AI-enabled technologies might make specifically the usually cost-intensive Orphan Drug development more economically viable. This presentation firstly, creates a basic necessity for understanding AI and answered the question of what exactly Artificial intelligence is? Once the stuff of science fiction, AI has made the leap to practical reality. Accessed May 19, 2022, [8] https://www.antidote.me View in article, Aditya Kudumala, Leverage operational data with clinical trial analytics:Take three minutes to learn how analytics can help, Deloitte Development LLC, accessed December 18, 2019. severe headache -> not serious) mnemonic: severiTTy = InTensiTy, Temporal relationship: Positive if AE timing within use or half-life of drug (positive, suggestive, compatible, weak, negative), Signal: Event information after drug approved providing new adverse or beneficial knowledge about IP that justifies further studying (PMS = signal detection, validation, confirmation, analysis, & assessment and recommendation for action), Identified risk: Event noticed in signal evaluation known to be related/listed on product information, Potential risk: Event noticed in signal evaluation scientifically related to product but not listed on product information, Important risk/Safety concern: Identified or potential risk that can impact risk-benefit ratio, Risk-benefit ratio: Ratio of IPs positive therapeutic effect to risks of safety/efficacy, Summary of product characteristics (SmPC/SPC): guide for doctors to use IP, E2A: Clinical safety data management: Definitions and standards for expedited reporting, What is e2b in pharmacovigilance? Medical and operational experts can incorporate AI algorithms into use cases including automation of image analysis, predictive analytics about trends in the meta data, and tailored patient engagement for improved compliance. It become important to understand artificial intelligence, the types of artificial intelligence, and its application in day-to-day life. What is the perspective of Black professionals and patient advocates as the medical and scientific industries grapple with effective ways to engage minority population? For instance, an "expert system" was built, employing the stages of questionnaire creation, network code development, pilot verification by expert panels, and clinical verification as an artificial intelligence diagnostic tool. to receive more business insights, analysis, and perspectives from Deloitte Insights, Telecommunications, Media & Entertainment, Intelligent clinical trials: Transforming through AI-enabled engagement, Artificial Intelligence for Clinical Trial Design, Digital R&D: Transforming the future of clinical development, Clinical Trial Site Selection: Best Practices, The innovative startups improving clinical trial recruitment, enrollment, retention, and design, Leverage operational data with clinical trial analytics:Take three minutes to learn how analytics can help. Our pharmacovigilance training and regulatory affairs certification is a course that takes one week to complete. Drug costs are unsustainably high, but using AI in the recruitment phase of clinical trials could play a hand in lowering them. Regulators around the globe have released guidance to encourage biopharma companies to use RWD strategies.11 Innovative trials using RWD are likely to play an increasing role in the regulatory process by defining new, patient-centred endpoints. In the United States, Deloitte refers to one or more of the US member firms of DTTL, their related entities that operate using the "Deloitte" name in the United States and their respective affiliates. The face of the world is changing and your success is tied to reaching ethnic minorities. As you know, every new drug, device, procedure or treatment must be tested on real patients in clinical trials to show both that it is safe and that it works. Bethesda, MD 20894, Web Policies Read the full report, Intelligent clinical trials: Transforming through AI-enabled engagement, for more insights. Comparative effectiveness from a single-arm trial and real-world data: alectinib versus ceritinib. Through careful attention paid both before and after drugs enter the market via pre-clinical trials and post-marketing surveillance activities respectively, pharmaceutical companies can provide adequate protection against potential risks associated with their products while still meeting regulatory requirements for approval at each stage of development. The main challenges in AI clinical integration. doi: 10.15420/aer.2019.19. This website is for informational purposes only. Artificial Intelligence (AI) supported technologies play a crucial role in clinical research: For example, during the COVID-19 pandemic the Biotech Company BenevolentAI found through a machine-learning approach that the kinase inhibitor Baricitinib, commonly used to treat arthritis, could also improve COVID-19 outcomes. Artificial intelligence in clinical trials?! Created based on information from [4,8,9,10]. These partnerships combine tech giants and startups core expertise in digital science with biopharmas knowledge and skills in medical science.10. IMPACT OF ARTIFICIAL INTELLIGENCE ON HEALTHCARE INDUSTRY. If so, share your PPT presentation slides online with PowerShow.com. Thus, this work presents AI clinical applications in a comprehensive manner, discussing the recent literature studies classified according to medical specialties. With its technology, Insilico Medicine discovered a molecule designed to inhibit the formation of substances that alter lung tissue in just 46 days (3). View in article, Dawn Anderson et al., Digital R&D: Transforming the future of clinical development, Deloitte Insights, February 2018, accessed December 17, 2019. The certificate makes it easier than ever before to land your dream job, giving you access like never before! AI platforms excel in recognizing complex patterns in medical data and provide a quantitative . 2020 Oct;49(9):849-856. doi: 10.1111/jop.13042. Our industry is rightfully focused on the importance of diversity, equity, and inclusion in clinical trials. However, the life sciences and health care industries are on the brink of large-scale disruption driven by interoperable data, open and secure platforms, consumer-driven care and a fundamental shift from health care to health. After feedback iterations throughout the past years, the AIA is currently under review at the European Parliament. This panel will discuss opportunities for AI to help sponsor and site stakeholders focus more on patient outcomes and perform their jobs more effectively. official website and that any information you provide is encrypted Show full caption View Large Image Download Hi-res image Download (PPT) Patient Selection Every clinical trial poses individual requirements on participating patients with regards to eligibility, suitability, motivation, and empowerment to enrol. 8600 Rockville Pike Adapted from [14]. For example, Insilico Medicine states that the process of discovering and moving its candidate into trial phase cost 2.6 million US-Dollars, significantly less than it had cost without using AI-enabled technologies (12). Samiksha Chaugule. In conclusion, the areas of application of AI-enabled technologies and machine learning in clinical research are manifold and pull through the full drug discovery process. Investigator and site selection: One of the most important aspects of a trial is selecting high-functioning investigator sites. ML in drug discovery. AI for Clinical Data Utilization Across Full Product Cycle. This can include analyzing adverse event data during pre-clinical trials in order to identify potential problems before a drug is marketed as well as assessing any additional risks that could occur after a drug goes on sale. 2. You will be able to open up a world of opportunities in pharmacovigilance and get qualified for entry-level roles as drug safety jobs: Common titles for pharmacovigilance officer jobs include: Drug Safety Officer, Pharmacovigilance Officer, PV Officer, Drug Safety Quality Assurance Officer, Clinical Safety Manager, Global Regulatory Affairs & Safety Strategic Lead, Medical Safety Physician/MD/MBBS or IMG, Risk Management and Mitigation Specialist, Clinical Scientist Advisor in Pharmacovigilance and Drug Surveillance, Drug Regulatory Affairs Professional with PV Knowledge and Experience, Senior Regulatory Affairs Associate with PV Expertise and Knowledge, Senior Clinical Trial Safety Associate or Specialist, MedDRA Coder (Medical Dictionary for Regulatory Activities), PV Compliance Reviewer or Auditor, GCP (Good Clinical Practices) Specialist with PV Knowledge and experience. Work and is it safe key objectives: surveillance, operations and focus one year ) ( )... 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