Responsibilities Collaborates and works closely with cross-functional teams, including clinical and safety stakeholders, to understand their requirements and build analytical solutions. Performs data cleaning, transformation, and other data engineering activities to ensure data quality, consistency, and compatibility for analyses. Develops and implements data analyses plans to answer questions from clinical and safety teams and stakeholders. Applies analytical and/or statistical techniques to analyze data and generate insights to answer clinical and safety questions. Builds effective and user-friendly dashboards and data visualizations to answer key clinical, safety and regulatory questions. Communicates and shares insights with technical and non-technical cross-functional stakeholders, providing data and insights interpretation and understanding. Contributes to qualitative and quantitative research projects through collaboration with cross-functional teams (Pharmacovigilance, Epidemiology, Biostats, etc.) Demonstrates a passion for learning new tools and technology, conducting regular assessments and performance evaluations of our analytics and data visualization platforms, identifying areas for improvement and implementing/recommending appropriate solutions . Acts as a subject matter expert on analytics and business intelligence, sharing knowledge and best practices with the wider organization and participating in knowledge-sharing sessions. Enables a culture of inclusiveness, respect for diversity, compliance with process and allows for the questioning and challenging of others in a respectful and constructive manner.     Qualification & Experience Bachelor's or Master's (preferred) degree in a relevant field, such as Biostatistics, Analytics, Engineering, or related discipline. Minimum of 5+ years of experience in data analysis, statistical modeling, and/or data visualization, preferably within the biopharma or healthcare industry. Experience applying statistical and analytical techniques to analyze clinical and real-world datasets.  

One of our clients, a well established hospital with branches in Bangalore, Mysuru, Mumbai and Delhi is looking for Fresher MBBS Doctor Qualifications and Experience Experience: Fresher Education: MBBS   Responsiblities Conduct regular thorough examinations on patients to check and record their health and normal physical development Examine sick patients to determine their condition and ask intuitive questions to gather information about symptoms Reach an informed diagnosis based on scientific knowledge and individual medical history Prescribe medications and give detailed instructions for administration Prescribe and interpret appropriate lab tests to gain more information about possible infections or abnormalities Prepare and administer vaccines according to the governmental vaccination plan Examine and treat injuries and refer the patients to physicians of other disciplines when necessary (e.g. surgeons, ophthalmologists, orthopedists etc.) Advise patients on diet, exercise and disease preventive measures Keep updated records of patients illnesses, surgeries or other medical episodes allergic shocks, injuries etc.

Responsibilities Design and manage the development of modular, reusable, elegantly designed and maintainable software or solutions that supports the RA organization as well as other Cross Functional strategic initiatives. Participate fit-gap workshops with business providing effort estimates and solutions proposals. Hands on, solution driven, and customer focused. Develop and maintain the code repositories for which you are responsible and respond rapidly to bug reports or security vulnerability issues. Embody and integrate software development best practices into your everyday work and inspire others within the engineering community to emulate these practices. Collaborate extensively with your colleagues across Security, Compliance, Engineering, Project Management, Product Management, Product Service Management and Business Management. Continue support for moving Publishing other RA platforms to the cloud. Ensure delivered solutions adhere to architectural and development standards, best practices, and meet requirements as recommended in the architecture handbook. Ensure designed solutions are aligned with Data and Analytics strategy standards and roadmap. Bring innovations to the solutions and add measurable values to RA Business.   Qualification & Experience University degree in Information Technology, Computer Sciences, Life Sciences or similar.. 10+ years of experience in IT technology development experience, preferably with 5+ years of experience working with Pharma Regulatory affairs (RA) business. Experience working in with RA Publishing business is a plus.  

Responsibilities Caring for neonates at the remote NICUs from a centralized care center  Manage these patients and document their progress, troubleshoot ICU issues, coordinate bedside team in accordance with global standards, and escalate issues Should be aware of ICU patients monitoring parameters like SpO2, cardiorespiratory, NIBP, Invasive BP, CVP, ventilation parameters, non-invasive ventilation parameters, CPAP/HFNC settings and others Conducting tele rounds which involve patient review, daily rounds, review of labs and radiology, drug charts, compliance to protocols Liaising with the bedside team actively and providing critical care expertise in real time to augment the delivery of critical care to the NICUs Check-ins with regular intermittent tele rounds on sick patients and initiating appropriate actions with the help of the tele NICU team in collaboration with the bedside team Documenting patient-level data and communication in our smartICU platform, RADAR keeping records of their health in NICU, diagnosis and documenting patients' symptoms and medical history. Identifying changes in the infant?s symptoms and intervening in emergency situations Following appropriate guidelines and schedules Keeping and tracking records for vital signs like temperature, pulse, breathing, oxygenation and blood pressure, as well as any signs of distress due to birth asphyxia and trauma, respiratory distress, apnea, aspiration, sepsis, etc., in critically ill infants.   Qualification & Experience Fellowship in Neonatology or Pediatrics hands-on NICU experience in a well-reputed hospital  4 to 6 years of experience   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

Responsibilities Committed to quality and excellence in compliance and conformance With the reasonable understanding of regional regulations, would perform the evaluation of the notifications assigned. Accountable for maintaining the HA status in corporate change and dossier management system for the allocated Regions / Markets Contributes independently and manages own time to meet the timelines. Work in collaboration with GRA colleagues to ensure the gaps are identified and escalated on time. Independently Perform accurate updates in system for most of the cases and consult with TL/Designee for clarification of any discrepancies in complex cases, before updating the system. Makes informed decisions on straight cases within guidelines and policies Support for updates in system for License withdrawals Operate in line with internal SOPs and policies Adhere to standard turnaround timelines Escalate any potential compliance issues to management Support periodic and ad-hoc system reports to estimate metrics Contribute to local and regional regulatory initiatives promoting a culture aligned with Pfizer values Assist in ensuring internal regulatory processes and procedures are well documented Assist in remediation activities Support the teams in ADHOC activities Shares the learning time to time with the team colleagues   Qualificatio & Experience Preferred Qualification – Master’s / Bachelor’s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences. Preferred Year Of Experience - 2 to 4 years of experience Type of Experience – Any relevant experience in Pharmaceutical or relevant industry. Experience in Regulatory or Quality or Compliance roles is preferable.  

Responsibilities Carry out case processing activities Review, rank, verify, process and document case-related information: event terms; validity, seriousness, special scenarios; timelines; accuracy and consistency. Process cases based on these assessments Review case criteria to determine appropriate workflow for case processing Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately Write and edit case narrative Determine and perform appropriate case follow-up, including generation of follow-up requests Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios Liaise with key partners, locally, and other stakeholders regarding safety data collection and data reconciliation Develop and maintain expertise and knowledge for applicable corporate and global regulations, for guidelines, Standard Operating Procedures, for data entry conventions, and for search functions in the safety database Determine reportability of scheduled reports, ensuring adherence to regulatory requirements Consistently apply regulatory requirements and Pfizer policies Participate, as appropriate, in local, internal and external safety activities.     Qualification & Experience Top 10 graduating students of Pharm. D or M. Pharm (Pharmacovigilance/Pharmacology/Pharmacy Practice) or B. Pharm. We prefer students graduating in 2024 over 2023 graduates. But if the graduating students can’t receive their provisional certificates before Jun 2024, we are okay to consider 2023 graduates.  

Responsibilities Functions as support for GRS-CMC to perform the following activities (under supervision) for Nitrosamine assessment: Step 1 Assessment for Nitrosamine risk Step 2 Confirmatory testing Responsible for effective review and providing timely feedback to the GRL/RRL/CRL on technical documents (on a need basis). Remediation Planning: Effective coordination with the GRL/RRL/CRLs, and extend support as needed towards preparation, review and finalization of Global Regulatory Strategy Documents (GRSDs). Submission Execution: Author required CTD sections for filing of supplements /variations,ensuring effective data presentation and quality, as per the finalized GRSD supporting GRS CMC. Support the data alignment team related to RPS Identifies and assesses regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate the risks. Works under supervision. Performs all assignments using established procedures and general instructions on the process. Remains knowledgeable about current regulations / guidelines and correlates in the assigned projects.     Qualification & Experience Bachelors or Master in Science / Pharmacy Preferred Experience Minimum 3 Years in working independently in the Regulatory Affairs function in a reputed Pharmaceutical Organization with major experience in handling post approval changes to health authorities.  

Responsibilities   Jointly develop the market/local KOL engagement plan with other MSLs, identify and segment KOLs according to their scientific interest and related affiliations and build the KOL network pre- and post-launch. Engage with KOLs using deep scientific expertise and knowledge of AZ's marketed products and compounds in development. Provide support to the Global Medicines Development (GMD) team on clinical site identification and patient recruitment for Phase I, II & III studies. Create opportunities to complement existing flow of clinical data for AZ's products in line with stakeholder needs, i.e., by identifying pre-clinical, clinical and post-marketing study investigators in alignment with the Development Plan, and engaging in discussions on the ISS Programme with potential investigators. Provides support to the internal Global Medicines Development (GMD) team on clinical site identification Engage with the medical / scientific community in a highly credible, balanced/objective way, representing AZ's dedication to and excellence in science Prepare and give relevant high level medical science presentations at congresses, symposia and scientific meetings Provide support for content development, agreeing agendas and delivery of effective clinical presentations e.g., advisory boards Help to develop medical science literature, i.e., write, edit and publish scientific articles and papers   Qualification & Experience MBBS/MD-Pharmacology Sound knowledge of basic research, drug discovery, drug development, clinical environment Experience in pharmaceutical industry, health care or research environment Proven ability to understand, assimilate and communicate scientific information Proven track record to engage and develop lasting relationships with key thought leaders in complex clinical environments  

Responsibilities Independently handle clinical regulatory writing activities across a complex portfolio of work. Author the most complex clinical-regulatory documents within a program by ensuring that relevant regulatory, technical and quality standards are achieved, and that relevant processes and best practice are applied. As part of a clinical delivery or submission team, provide strategic communications leadership to projects, establish communication standards and best practice, and continuously advocate for quality and efficiency. When acting as a submission lead, drive the development of the clinical Submission Communication Strategy (cSCS). Lead internal/external authoring teams and provide strong partnership with vendor medical writers to ensure delivery to time and quality. Drive the clinical interpretation of complex data and information and condense it into clear, concise and accurate messages that address customer information requirements. Be a strategic problem solver and demonstrate strategic review capabilities. Proactively collaborative with other functions at the program level. Support the development of Clinical Regulatory Writing Managers. Drive continuous improvement and operational excellence from a communications leadership perspective, including representing the skill on drug and non-drug projects, as required.   Qualification & Experience Life Sciences degree in an appropriate field. Significant medical writing experience in the pharmaceutical industry or CRO. Ability to advise and lead communication projects. Understand drug development and communication process from development, launch through life cycle management.  

Responsibilities As a Director, you will provide International CMC RA expertise across the business functions, lead key business improvement initiatives, and provide operational, tactical, and strategic International CMC RA expertise and direction for CMC submissions across the lifecycle of a product. You will also lead knowledge sharing and provide coaching both within CMC RA and wider business functions. Qualification  & Experience Degree /PhD or equivalent professional qualification in a science or technical field such as pharmacy, biology, chemistry or biological science. Breadth of knowledge of manufacturing, project, technical and regulatory project management. Strong understanding of regulatory affairs globally Direct Regulatory Affairs CMC experience with submissions for Synthetics and/or biologic and biotechnology derived products