Barinthus Biotherapeutics is hiring a Senior Director or Director of Regulatory Affairs Strategy. Embark on a journey of discovery, guiding the immune system to conquer chronic diseases, autoimmunity, and cancer. •Lead the global regulatory strategy for our cutting-edge immunotherapeutic products. •Manage strategic regulatory documents and interactions with global agencies. • Align regulatory strategies with product development plans, working with diverse teams. Click here for more details about this opportunity and how to apply: https://ow.ly/fwKW50SyAcH #blackpharma #careerinpharma #RegulatoryAffairs #ScienceCareers #opportunitiesinpharma #workinpharma #BarinthusBiotherapeutics
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Facing financial constraints can be a make-or-break for clinical-stage biotech firms. Learn how our partnership with a leading cellular therapy innovator helped them overcome budgetary challenges through strategic, high-impact placements. #CompassConsulting #CaseStudy #BioTech #BioTechHiring #HiringSuccess #HiringTrends #LifeSciences
How can strategic recruitment transform the potential of a clinical-stage biotech with limited funding? Discover Compass's recent partnership with an innovative cellular therapy pioneer facing budgetary constraints. Through expert placements in clinical pharmacovigilance, financial control, and research and development, the company was able to navigate regulatory hurdles and drive projects forward. Read more here: https://lnkd.in/ey_KcUUE #BiotechSuccess #StrategicRecruitment #CompassPartnership #LifeSciencesRecruiting #LifeSciencesStaffing
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👀 Interested in semantic modeling approaches in relation to the OMOP CDM? Register for our upcoming webinar series 👇
🌐 Join Us for a Pioneering Webinar Series on Drug Safety! Discover the future of pharmacovigilance with The Hyve's webinar series: "Beyond Traditional Approaches in Drug Safety: The Power of Semantic Modeling and Knowledge Graphs." The first webinar, titled "Integrating Biomedical Ontologies with OMOP: Opportunities for Drug Safety Monitoring", will explore the convergence of data harmonization and semantic models in the context of drug safety monitoring. This session features Dr. Tiffany Callahan (IBM Research Almaden)'s presentation on the topic of "Ontologizing Health Systems to Facilitate Translational Discovery and Improve Drug Safety", followed by a panel discussion. 🗓️ Save the Date: October 10th, 2023 🕒 Time: 15:30-16:30 CEST 📌 Register here: https://lnkd.in/emt-QXqb Read more about this webinar series here: https://lnkd.in/emqgqx2U Join us in shaping the future of drug safety monitoring. 🚀 #DrugSafety #Webinar #Pharmacovigilance #TheHyve #OMOP #ontology #knowledgegraph
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Specialized lab billing prowess to boost bottom lines. XyberMed's tailored packages ensure full reimbursement for census, toxicology, molecular & clinical services. Visit us: https://xybermed.com/ . . . . . . . #Xybermed #healthcaretechnology #medicalbilling #healthcarefacilities #innovationinhealthcare #patientengagement #streamlinedprocesses #revenuecyclemanagement #healthcareadministration #independentpractitioners #tailoredsolutions #industrystandards #patientcare #billingplatform #healthcarerevolution #intuitivesystem #administrativebrilliance #compliance #medicalpractitioners #flexibletechnology #inclusiveplatform #revenuegeneration #healthcareinnovation #efficientbilling #patientcentricapproach #simplifieddecisionmaking #healthcaremanagement #empoweringpractitioners #enhancedefficiency
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🌐 Join Us for a Pioneering Webinar Series on Drug Safety! Discover the future of pharmacovigilance with The Hyve's webinar series: "Beyond Traditional Approaches in Drug Safety: The Power of Semantic Modeling and Knowledge Graphs." The first webinar, titled "Integrating Biomedical Ontologies with OMOP: Opportunities for Drug Safety Monitoring", will explore the convergence of data harmonization and semantic models in the context of drug safety monitoring. This session features Dr. Tiffany Callahan (IBM Research Almaden)'s presentation on the topic of "Ontologizing Health Systems to Facilitate Translational Discovery and Improve Drug Safety", followed by a panel discussion. 🗓️ Save the Date: October 10th, 2023 🕒 Time: 15:30-16:30 CEST 📌 Register here: https://lnkd.in/emt-QXqb Read more about this webinar series here: https://lnkd.in/emqgqx2U Join us in shaping the future of drug safety monitoring. 🚀 #DrugSafety #Webinar #Pharmacovigilance #TheHyve #OMOP #ontology #knowledgegraph
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M pharm graduate, Actively looking for job opportunities in field of Clinical data management, Pharmacovigilance.
Dear LinkedIn family, I am looking to start my career in clinical data management,hence to acquire some knowledge for cracking interview.So that I was going to do certification course in Clinical trail management, clinical data management, Pharmacovigilance and medical writing.As of now I have completed CTM(Clinical trail management) module,in that I have learned about the following topics.. ✓ Drug discovery and drug development process. ✓Clinical trail phases (phase -l, ll,lll &lV). ✓Different parties involved in the Clinical trails. ✓INDA,NDA & ANDA Fillings ✓History of clinical trails. ✓Different regulatory bodies around the world. ✓ICH- cGCP guidelines. ✓Adverse drug reaction, Adverse Drug event & serious Adverse drug reactions. *I am going to explain in detail about: **Clinical Research process :- Drug discovery (2-5 yrs ) || Preclinical trails (1-2 yrs) || Investigational new drug application (INAD) || Clinical trail phases (l,ll, lll) || New drug application (NDA) || Phase -lV(Post marketing surveillance) **Drug discovery and drug development process:- - In drug discovery process there are 4 stages. 1.Target (Inside the body)selection 2. Lead(New drug)finding 3. Lead Optimisation 4. Pharmacological profiling -mainly Reverse pharmacology is used for faster drug discovery rather than forward pharmacology. -Remaining topics will be covered in my upcoming posts.Additional thanks to Amaan Ansari for your guidance.
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#pharmacovigilance and #personalizedmedicine, do they work together? The intersection of pharmacovigilance and personalized medicine is a new frontier in healthcare that promises to revolutionize patient health. But what does this mean, and why should we care? Personalized medicine, the tailoring of medical treatment to the individual characteristics of each patient, has been gaining traction. It's a shift from a 'one size fits all' approach to treating patients, to one that considers individual genetic makeup, lifestyle, and environment. Pharmacovigilance, on the other hand, is the science of detecting, assessing, understanding, and preventing adverse effects or any other drug-related problems. It's a critical component of patient safety and public health. So, how do these two fields intersect? With the rise of personalized medicine, we're seeing an increase in the use of targeted therapies - drugs designed to treat specific diseases based on an individual's genetic makeup. These therapies, while promising, also present new challenges for pharmacovigilance. The traditional methods of monitoring drug safety may not be sufficient for these targeted therapies. We need new strategies and tools to monitor and manage the risks associated with these treatments. These new ideas are an exciting and challenging area that requires innovative thinking and collaboration across disciplines. As we continue to explore these two fields, we must remember that the ultimate goal is to improve patient care. By integrating pharmacovigilance and personalized medicine, we can ensure that each patient receives the safest and most effective treatment possible. What are your thoughts on this intersection? How do you see it shaping the future of healthcare? #pharmacovigilance #pharmacists #personalizedmedicine #pharmacogenomics 😉
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DR. PEG FLETCHER WILL BE A FEATURED SPEAKER at the PHUSE Computational Science Symposium on September 18-20, 2023 Dr. Peg Fletcher, MedAssessment President and CEO, will be discussing “Challenges in the Interpretation of Data at the Intersection of Medicine and Statistics”. Dr. Fletcher will join Mac Gordon, Director Biostatistics - Janssen, representatives from the FDA, and other speakers from industry to discuss and solve for some of industry's most relevant challenges, with respect to the intersection of drug development and technology. https://lnkd.in/eNScWhwh medassessment.com #phusecss2023 #phuse #safety #safetyevaluation #drugdevelopment #datascience #clinicaltrials #clinicalresearch #pharmaceuticalindustry #pharmacovigilance #medassessment
MedAssessment, Inc. US Based CRO of pharmacovigilance experts
https://medassessment.com
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#pharmacovigilance and #personalizedmedicine, do they work together? The intersection of pharmacovigilance and personalized medicine is a new frontier in healthcare that promises to revolutionize patient health. But what does this mean, and why should we care? Personalized medicine, the tailoring of medical treatment to the individual characteristics of each patient, has been gaining traction. It's a shift from a 'one size fits all' approach to treating patients, to one that considers individual genetic makeup, lifestyle, and environment. Pharmacovigilance, on the other hand, is the science of detecting, assessing, understanding, and preventing adverse effects or any other drug-related problems. It's a critical component of patient safety and public health. So, how do these two fields intersect? With the rise of personalized medicine, we're seeing an increase in the use of targeted therapies - drugs designed to treat specific diseases based on an individual's genetic makeup. These therapies, while promising, also present new challenges for pharmacovigilance. The traditional methods of monitoring drug safety may not be sufficient for these targeted therapies. We need new strategies and tools to monitor and manage the risks associated with these treatments. These new ideas are an exciting and challenging area that requires innovative thinking and collaboration across disciplines. As we continue to explore these two fields, we must remember that the ultimate goal is to improve patient care. By integrating pharmacovigilance and personalized medicine, we can ensure that each patient receives the safest and most effective treatment possible. What are your thoughts on this intersection? How do you see it shaping the future of healthcare? #pharmacovigilance #pharmacists #personalizedmedicine #pharmacogenomics
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Unlocking Safety in Biotech: The Might of Pharmacovigilance In the bustling world of biotechnology, where innovation and novel therapeutics come to life, the safety of patients remains paramount. This is where pharmacovigilance (PV) comes in - an unsung hero in the biotech narrative. Pharmacovigilance goes beyond mere compliance; it's the heartbeat of patient safety and therapeutic efficacy throughout the lifecycle of a drug. From initial discovery to post-market surveillance, PV provides a safety net, catching adverse drug reactions (ADRs) before they become widespread issues. As biotech companies innovate at lightning speed, pharmacovigilance acts as the rudder, guiding these companies through the tumultuous waves of drug development and patient interaction. The rising complexities of biotech therapies, such as gene and cell treatments, amplify the need for robust PV systems. These intricate modalities can present unique safety profiles that only vigilant monitoring can manage effectively. By proactively identifying and evaluating risks, PV ensures that the monumental potential of biotech innovations can be realized without compromising safety. Moreover, the data collected by pharmacovigilance teams is invaluable - it not only protects public health but also informs future research and development. Patterns in ADRs can lead to improved drug formulations and dosing regimens, ultimately enhancing therapeutic outcomes. Pharmacovigilance isn't a static backdrop; it's evolving, harnessing advancements like AI and real-world evidence to anticipate and mitigate risks more efficiently. This evolution is key in an industry that's always on the frontier of science. In summary, pharmacovigilance is the biotech industry's sentinel, a role that grows in significance as the industry itself expands and diversifies. Ignoring its importance is not just risky; it's a disservice to the very people the industry aims to heal and help. Pharmacovigilance is, indeed, the shield that allows the sword of innovation to strike true. #Pharmacovigilance #Biotech #PatientSafety
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currently looking in clinical data management | pharmacovigilance | clinical research associate | medical coding |regulatory affairs
Hello connections 🖐️ Drug discovery development : Process of identifying a compound therapeutically useful in treating diseases.Entire process is time consuming and also complex it takes 10 - 15 yrs. Stages : 1• Target identification 2• Target validation 3• Lead identification 4• Lead optimization Drug discovery: 2-5 yrs Preclinical : 1-2 yrs Clinical : 5-7 yrs Regulatory approval : 1-2 yrs Preclinical phase : Laboratory test on a new drug substance usually done on animal subjects to see whether the treatment really works and if it is safe to test on humans. To determine pharmacological profile to see how the drug is acting on the body. 1• Pharmacological testing 2• Toxicological testing Clinical trials: Studies that help to determine the safety and effectiveness of an intervention. Phase -1 : To determine pharmacokinetic profile it takes nearly 1-8 months testing on health subjects. Phase-2 : To determine safety and efficacy it takes nearly 8 months - 2yrs testing on Target disease subjects. Phase -3 : To determine safety, efficacy and tolerability it takes nearly 2yrs-4yrs. Phase - 4 : Post marketing surveillance, ADR reporting. #cdm #clinicalresearch #clinicaltrials #clinicaldatamanagement
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