7 Fda Guidelines Jobs

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details To lead a team of Drug Safety Physicians working on ICSRs Projects. Conduct initial assessment and Medical Review of ICSRs into the safety database. Review and verify appropriate selection of adverse events from source documents, check the seriousness criteria, appropriate MedDRA code, suspect drug, concomitant medications, lab data, medical history, labelling, causality, review narrative and provide Company Causality Comment. Review and respond to any queries/comments from the Case Owner in the Safety database. Train and mentor PV associates on event capturing and general PV conventions as required. Acquire and maintain current knowledge of product and safety profiles for products across therapeutic areas. Escalate complex case issues on client products to Team Lead/Line Manager. To detail any follow-up information that is required and not already noted within the Safety database. To provide documentation of the review and case comments in Safety database in Medical Review workflow. Maintain good knowledge of databases, regulations, guidelines and SOPs. Maintain strong GPVP and GCP knowledge. Following ICH, EMA and FDA guidelines strongly and implementing them appropriately. To actively communicate and participate in internal project meetings. Participation in internal and external audits/inspections. Perform any other drug safety related activities as assigned by PharmaLex management. Degree in Medicine. PG degree in any discipline is an advantage but not mandatory. Minimum 3 years of relevant experience in Pharmacovigilance & Drug Safety. Strong interpersonal and organizational skills to be a good team player. High sense of responsibility, dedication, and desire to work under pressure as required. Highly service oriented. Previous exposure to corporate environment, pharma and life sciences industry is an advantage. Good communication skills. Fluent in English- spoken and written. What Cencora offers Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements. Full time Affiliated Companies Affiliated Companies: PharmaLex India Private Limited Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The companys continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email [HIDDEN TEXT]. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned Show more Show less

You are invited to join ARDEM Data Services Private Limited as a Medical Data Entry professional for patient records with a minimum of 1 year of experience in medical data annotation and document review. The ideal candidate should have a background in medical or pharmaceutical sciences and possess essential skills related to medical data management, regulatory guidelines (FDA, EMA, ICH, GCP), and patient report handling. This role requires prior experience working night shifts and is a permanent work-from-home position. Key Responsibilities - Review and annotate medical documents and patient records accurately. - Apply knowledge of FDA, EMA, ICH, and GCP guidelines to data management tasks. - Perform clinical data management activities. - Handle and process patient reports efficiently. - Ensure data quality and integrity during the entry and annotation process. Requirements - Qualification: B.Sc, M.Sc, B.Pharma, or M.Pharma. - Minimum 1 year of experience in medical data annotation and medical document review. - Mandatory experience working night shifts (US shift: 10:00 pm to 7:00 am). - Experience with FDA, EMA, ICH, and GCP guidelines. - Proficiency in Clinical Data Management and handling Patient Reports. - Only candidates with a medical background and medical data annotation experience will be considered. - Immediate joiner preferred. Technical Requirements - Laptop or Desktop: Windows (i5 or higher, 8GB RAM minimum) - Screen: 14 inches, Full HD (1920*1080) - Internet Speed: 100 Mbps or higher About ARDEM ARDEM is a leading Business Process Outsourcing and Business Process Automation service provider with a strong track record of delivering exceptional services to clients in the USA and Canada for over twenty years. We are dedicated to innovation and excellence in providing the best Business Process Outsourcing and Business Process Automation solutions to our customers. Note ARDEM prioritizes the security and privacy of all applicants and will never ask for personal or banking information during the hiring process for any data entry or processing work. If you are contacted by any party claiming to represent ARDEM Incorporated offering work-from-home jobs, please disregard and refer to ARDEM's Careers page for all open job positions. We apologize for any inconvenience caused by such fraudulent acts.,

As a Senior Medical Editor at Syneos Health, you will play a crucial role in ensuring that all documents meet or exceed sponsor and regulatory requirements such as FDA, EU, and other relevant guidelines. You will represent the editorial group in Medical Writing, collaborate with study teams, and provide technical support and expertise as needed. Your responsibilities will include monitoring timelines and budgets for assigned projects, conducting training for medical editing staff, and serving as a project lead for complex medical writing projects. In this role, you will copyedit assigned documents following American Medical Association (AMA) or various custom style guidelines, perform data integrity reviews to ensure accuracy, and contribute to the development of process improvement tools. Strong attention to detail, excellent grammatical and communication skills, and proficiency in Microsoft Office Suite are essential for success in this position. Additionally, you should have a Bachelor's degree in the life sciences, clinical sciences, or English/journalism, along with at least 5+ years of medical editing experience. As part of the global Medical Writing team, you will collaborate with passionate problem solvers to accelerate the delivery of therapies and make a meaningful impact on changing lives. Syneos Health is committed to developing its people through career progression, supportive line management, and a Total Self culture that values authenticity and diversity. Join us in creating a place where everyone feels like they belong and where your work truly matters everywhere. If you have a strong background in copyediting, data integrity review, and relevant publishing experience, along with a passion for making a difference in the healthcare industry, we invite you to explore this exciting opportunity at Syneos Health.,

As an Embedded Software Development Engineer, you will be responsible for designing, developing, and maintaining embedded medical devices to ensure reliability, efficiency, and performance. Your role will involve writing clean, well-documented, and maintainable code in C/C++ and other relevant languages. Collaboration with hardware teams to define system requirements and optimize software-hardware integration will be crucial. Additionally, you will develop devices in compliance with medical device standards such as ISO 13485 and IEC 62304. Adherence to safety critical software development practices, including risk management and failure mode analysis, is essential. You will be required to develop and execute test plans for unit, integration, and system level testing of firmware. Troubleshooting and resolving firmware issues using debugging tools and techniques will be part of your responsibilities. Creating and maintaining comprehensive documentation, including specifications, design documents, and tests, is also a key aspect of the role. Contribution to the preparation of documentation required for regulatory submissions and tracking software defects throughout the development lifecycle are expected. To be successful in this role, you should have 4-9 years of experience in embedded software development, with at least 2 years in the medical device industry. Proficiency in C/C++, assembly language, and real-time operating systems (RTOS) is required. Experience with microcontroller/microprocessor architectures, peripherals, and common communication protocols (RS232, I2C, SPI, RS485) is necessary. Familiarity with software development lifecycle (SDLC) tools and methodologies, version control systems (e.g., Git), and strong problem-solving, analytical, and debugging skills are essential. Excellent communication skills and the ability to work effectively in a team-oriented environment are also critical for this role. Desirable skills include strong knowledge of medical device standards (IEC 62304, ISO 13485), familiarity with FDA guidelines and the 510K submission process, experience with wireless communication protocols, and knowledge of cybersecurity principles in embedded systems. If you possess the required skills and experience and are looking for a challenging opportunity as an Embedded Software Development Engineer, this position based in IND Bengaluru - Technology Campus could be the next step in your career.,

Job Title: GLP-Quality Assurance Personnel Location: Bangalore, KA, IN, 560099 Syngene International Limited, Bengaluru is an innovation-led contract research, development, and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is a top priority, with a focus on ensuring safety guidelines, procedures, and SOPs are followed diligently. As a GLP-Quality Assurance Personnel at Syngene, you will play a crucial role in aligning laboratory practices with Good Laboratory Practice (GLP) guidelines to maintain the integrity and reliability of non-clinical safety and clinical studies. You will also work in a regulatory environment to ensure compliance with national and international standards set by organizations such as OECD, FDA, ICH, and ISO. Key Responsibilities: - Ensure compliance with OECD principles of GLP, ICH, and WHO-GCLP - Handle inspections and audits - Manage QMS activities including change controls, deviations, and CAPA - Review SOPs, study plans, and documentation related to QAU - Conduct inspections of studies, facilities, and processes in analytical and bioanalytical domains - Audit raw and electronic study data and reports - Review equipment and computerized system qualifications as per OECD Principles 17 and 21 CFR Part 11 Requirements: - Experience: 6-9 years - Knowledge of GLP principles as per OECD, ICH, FDA, and EPA guidelines - Proficiency in handling QMS activities - Ability to review SOPs and study plans for regulatory compliance - Understanding of data integrity policies and standards - Skilled in conducting inspections and audits - Competent in preparing and reviewing QAU documentation and SOPs Skills and Qualifications: - Master's degree in Pharmacology, Chemistry, or related field - Proficiency in handling multiple software applications and tools - Strong problem-solving skills with a scientific mindset - Ability to work collaboratively in a team environment - Excellent communication skills Syngene Values: - Excellence - Integrity - Professionalism Syngene is an equal opportunity employer dedicated to providing a safe and inclusive work environment for all employees.,

Excelya is a leading independent Contract Research Organization (CRO) in Europe, dedicated to providing a people-centered approach since its inception in 2014. As a part of the ambitious health company, with a team of 900 Excelyates, our unique service model offers a diverse array of projects, enabling professional growth and personal development. In collaboration with experts, Excelya aims to advance scientific knowledge and enhance the patient journey, striving to become the clinical research leader in Europe. As a Clinical Data Manager at Excelya, you will be responsible for executing Data Management tasks in compliance with regulatory standards and Client SOPs. Working under the supervision of senior staff, you will be involved in data cleaning, review, discrepancy management, and reconciliation activities on assigned studies. Additionally, you will collaborate with the Lead Data Manager, generate study metrics and reports, and participate in study documentation archiving. Excelya is currently seeking a Full Service Provider role of Clinical Data Manager I (CDMI) based in Bangalore, India. The role requires a candidate with a Bachelor's degree in a Scientific discipline, preferably with at least one year of experience as a Data Manager or relevant expertise. Knowledge of ICH GCP guidelines, clinical trial databases, data flow, and proficiency in office computer applications are essential requirements for this position. Effective communication skills, both verbal and written, along with a commitment to professionalism, ethics, and compliance, are key attributes we are looking for in potential candidates. The successful candidate for the role of Clinical Data Manager at Excelya should be fluent in both the local language and English. This full-time position is located in Bangalore and offers an opportunity to contribute to the field of Clinical Research. If you are passionate about making a difference in the healthcare industry and meet the mentioned requirements, we encourage you to apply for this exciting opportunity. If you are interested in this position, please reach out to Bhavya Reddy, HR Manager, for further details.,

The Quality Control (QC) Reviewer plays a crucial role in ensuring the accuracy, completeness, and compliance of laboratory and clinical data with regulatory guidelines, company policies, and industry standards. Your responsibilities include reviewing raw data, study documentation, and analytical reports to ensure adherence to protocols and regulatory requirements. By identifying discrepancies and errors, you will provide recommendations for corrective actions to maintain data integrity. Collaboration with laboratory analysts, study coordinators, and quality assurance teams is essential to resolve issues related to data accuracy and compliance. As a QC Reviewer, you will document your findings meticulously, preparing detailed reports for management and regulatory bodies. Additionally, you will participate in audits and inspections to uphold quality standards. To excel in this role, you should hold a Bachelors/Masters degree in Life Sciences, Pharmacy, Chemistry, or a related field. With 2-6 years of experience in Quality Control/Quality Assurance within the pharmaceutical or biotech industry, you are expected to have a strong understanding of GLP, GCP, FDA, EMA, and ICH guidelines. Proficiency in reviewing analytical data, clinical study reports, and laboratory documentation, along with excellent attention to detail and problem-solving skills, are essential. Effective communication and interpersonal skills are necessary to collaborate with cross-functional teams. Moreover, staying updated with regulatory changes and industry best practices will contribute to enhancing the organization's quality standards. Experience with bioanalytical, clinical, or preclinical study reviews, knowledge of electronic data capture (EDC), and the ability to handle multiple projects with tight deadlines are preferred skills for this role. Proficiency in Microsoft Office and Laboratory Information Management Systems (LIMS) would be advantageous.,