28 Ich Guidelines Jobs

As the PV Operations & Safety Systems Lead in Pharmacovigilance at Biocon Biologics, you will be part of a pioneering company dedicated to revolutionizing healthcare. With a focus on patient-centricity, affordable innovation, and disruptive thinking, our goal is to impact a billion lives globally. At our multicultural organization, you will collaborate closely with partners and patients, working towards the shared vision of providing high-quality, affordable biosimilars to individuals worldwide. Reporting to the Head of Pharmacovigilance, your role will involve overseeing Pharmacovigilance operations and PV Systems functions within the Clinical Development and Medical Affairs department. Your primary responsibility will be to ensure compliance with regulatory requirements throughout the end-to-end Pharmacovigilance activities. Additionally, you will play a key role in establishing and maintaining PV safety systems in alignment with global regulatory standards. Your leadership will be crucial in managing the global pharmacovigilance system, including standard operating procedures and the Global Safety Database. You will interact with vendors, PV service providers, and business partners to facilitate PV data exchange and compliance. Your expertise will be instrumental in responding to safety information requests from regulatory authorities and participating in regulatory inspections, audits, and corrective actions as needed. In addition to overseeing outsourced PV activities, you will serve as a technical subject matter expert for both internal and external stakeholders. Strong communication, project management, and negotiation skills are essential for success in this role. Your qualifications should include a Bachelor's degree in pharmacy or a healthcare discipline, or a Master's degree in Life Sciences with extensive PV experience. With 12+ years of pharmacovigilance experience, including a minimum of 9 years in the field, you should possess a deep understanding of Good Pharmacovigilance Practices and relevant regulations. Based in Bangalore, India, this position offers the opportunity to lead impactful initiatives in a dynamic and fast-paced environment. If you are a motivated self-starter with a passion for innovation and a commitment to excellence in pharmacovigilance, we invite you to join our team at Biocon Biologics.,

As a Safety & PV Specialist I at Syneos Health, based in the Pune Office, you will play a crucial role in ensuring the safety and pharmacovigilance of our products. Your primary responsibility will be to enter information into PVG quality and tracking systems for the receipt and tracking of ICSRs. Additionally, you will assist in the processing of ICSRs according to SOPs and project-specific safety plans. In this role, you will triage ICSRs, evaluate the data for completeness and accuracy, and ensure regulatory reportability. You will enter data into the safety database, code events, medical history, concomitant medications, and tests, and compile complete narrative summaries. Your attention to detail will be essential as you identify information to be queried and follow up until all queries are satisfactorily resolved. Moreover, you will be responsible for generating timely and accurate expedited reports in compliance with regulatory requirements. You will maintain safety tracking for assigned activities, perform literature screening and review for safety, drug coding, and MedDRA coding. Your role will also involve validation and submission of xEVMPD product records, management of duplicate ICSRs, activities related to SPOR/IDMP, quality review of ICSRs, and ensuring all relevant documents are submitted to the TMF and Pharmacovigilance System Master File. To excel in this position, you must maintain a thorough understanding and compliance with SOPs, global drug regulations, GCP, ICH guidelines, and project/program plans. Building constructive relationships with internal and external team members, participating in audits, and applying regulatory intelligence to safety reporting activities will be vital components of your role. Syneos Health is committed to developing its employees and providing a supportive and inclusive work environment where you can be your authentic self. Join us in our mission to accelerate customer success and make a meaningful impact on the lives of patients worldwide.,

As a Senior Medical Writer at Syneos Health, you play a vital role in leading the clear and accurate completion of medical writing deliverables. Your responsibilities include managing medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision. You will be responsible for completing various documents such as clinical study protocols, reports, patient narratives, annual reports, and more. Adhering to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, and client standards, is essential. Your role involves coordinating quality and editorial reviews, ensuring proper management of source documentation. As a peer reviewer for the internal team, you will ensure document scientific content, clarity, overall consistency, and proper format. Interacting and building good working relations with clients, department heads, and peers in various departments are crucial for producing high-quality writing deliverables. In addition to these responsibilities, you will mentor and lead less experienced medical writers on complex projects, developing deep expertise on key topics in the industry and regulatory requirements. Working within budget specifications for assigned projects while maintaining a high level of quality is a key aspect of your role. To qualify for this position, you should have a Bachelor's degree in a relevant discipline with relevant writing experience, while a graduate degree is preferred. 4-5 years of relevant experience in a disclosure platform and strong understanding of FDA and ICH regulations are necessary. Proficiency in MS Office, strong project and time management skills, and a good grasp of medical terminology and principles of clinical research are also required for this role. At Syneos Health, you will have the opportunity to work in a dynamic and challenging environment where you can make a difference. Join us in our mission to accelerate the delivery of therapies and change lives.,

Date: 2 Jul 2025 Location: Bangalore, KA, IN, 560099 Custom Field 1: Dedicated Centre Job Description Designation: Research Associate (9-I) or Senior Research Associate (9-II) Job Location: Bangalore Department: BBRC PD ARD GMP About Syngene Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development, and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical industries worldwide. Syngenes clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA, and Herbalife. Its innovative culture is driven by the passion of its 4240- a strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market, and lower the cost of innovation. Job Purpose (1-2 Lines): Analytical Research and Development working on Analytical GMP testing (AGT), and Syngene BMS Laboratory (SBL) stability programs Key Responsibilities Testing of samples (drug substance and drug product for release testing and stability) using chromatographic, dissolution, and wet analytical techniques under a GMP environment following cGMP practices Analysis of API clinical campaign samples manufactured in Syngene pilot plant Qualification or requalification of API reference standards. Performing instrument calibration and qualification Performing method validation, and method transfers Troubleshooting HPLC, dissolution apparatus and other analytical instruments in the lab Deliver analytical results within the established windows and as per applicable guidelines Compliance & implementation of quality systems Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety Electronic lab notebook documentation Miscellaneous lab responsibilities Educational Qualifications: M.Sc. Chemistry for 9-I; M.Sc. Chemistry or M. Pharm for 9-II; Technical/Functional Skills The candidate should have a good educational and theoretical, analytical chemistry background Good knowledge of analytical techniques The candidate should understand instrument calibration, qualification, method validation, and analytical testing Good understanding of documentation as per GxP requirements (electronic notebook) The candidate should have good proficiency in MS office tools Experience in stability samples testing and good knowledge of ICH guidelines & cGMP regulatory requirements Must have worked in a cGMP-regulated environment, exposure to regulatory inspections like US FDA, MHRA, etc. is preferred. Experience: 1-2 years with M.Sc. for 9-I ; 3-5 years with M.Sc. or 1-2 years with M. Pharm for 9-II Behavioral Skills Strong commitment toward work and a high level of dedication, enthusiasm, and motivation Good speaking-listening-writing skills, attention to detail, proactive self-starter Ability to work successfully in a dynamic environment Should be able to work in a team and flexible for working in shifts. Equal Opportunity Employer It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities. Show more Show less

At Quanticate, we&aposre pioneers in providing top-tier statistical and data management support to our clients. We&aposre seeking a dedicated "Clinical Data Manager I" who&aposs committed to upholding the highest standards, following procedures, and ensuring compliance with regulations, all while providing exceptional customer care. As a "Clinical Data Manager I" you will lead, co-ordinate, and action all tasks relating to Clinical Data Management from the start to the finish of a study & to project manage studies across CDM functions. Core Accountabilities: Activities required of a Clinical Data Manager I (however not restricted to) are as below: To contribute to the efficient running of the CDM department as part of the CDM leadership team. Ensure launch, delivery, and completion of all CDM procedures according to contractual agreement and relevant SOPs, guidelines, and regulations To pro-actively keep abreast of current clinical data management developments and systems To assist in the creation and review of in-house SOPs. To research and provide input into in-house strategies and systems. To perform medical coding activities on projects, if assigned. To perform other reasonable tasks as requested by management. Ensure consistency of process and quality across projects. Project management for allocated projects: To help plan and manage study timelines and resources. To manage progress against schedules and report to management. To perform project management across all functions for a study as appropriate. Management of CRFs and all related tasks Management of allocated staff: Allocation of projects in conjunction with Project Management, as appropriate Performance reviews, as required. Administer training and development of staff, as required. Key Relationships: Act as the primary CDM contact, both external and internal, for Quanticate projects. Manage work assignment and delivery of project tasks to the data processing and programming team as required Line management responsibilities for any assigned direct reports, including professional development/training and performance appraisals. Requirements Qualified to an appropriate standard, preferably to degree level in a life sciences subject Four to seven years of relevant experience in CRO Clinical Data Management domain. Extensive knowledge of at least 2 Clinical Data Management systems such as Oracle Clinical, Medidata Rave, Inform Thorough knowledge of ICH Guidelines and GCP including regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing CDM project leadership, strong communication skills Sound knowledge and experience on pharmaceutical industry and requirements for delivery of clinical trials Proven ability in client relationship management Quanticate will never ask for payments as part of the recruitment or hiring process, and all legitimate correspondence from Quanticate will come exclusively from our @quanticate.com domain name. Hiring at Quanticate is based purely on merit and we do not ask or require candidates to deposit any money or complete any paid for courses as part of the process. Further guidance on our recruitment process and tips on how to stay safe during your job search can be found on our website at https://www.quanticate.com/careers-guidance. Benefits ? Competitive salary (Open to discussion based on experience ? Flexible working hours ? Holidays (Annual Leave, Sick Leave, Casual Leave and Bank holidays) ? Medical Insurance for self and immediate family ? Gratuity ? Accidental Coverage ? Quanticate offers a variety of different learning development opportunities to help you progress (mentoring, coaching, e- learning, job shadowing) Show more Show less

Skill required: Regulatory Services - Life Sciences Regulatory Operations Designation: LifeScience Regulatory Svs Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. The incumbent will perform the regulatory operations tasks of bookmarking and hyper linking for granular components (documents) of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components. Coordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for sBachelor Degree in Life Sciences Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Show more Show less

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The Project Lead Pharmacovigilance position at DDReg offers a compelling opportunity for you to advance your career in pharmacovigilance project management. As a crucial member of the Project Management team, you will play a key role in overseeing and directing all pharmacovigilance services. Your responsibilities will include serving as the primary contact for clients, ensuring project activities align with client needs and regulatory requirements, and maintaining high-quality work standards to achieve client satisfaction. Your key accountabilities in this role will involve closely managing client relations by acting as the main liaison between clients and project teams. You will be responsible for fostering strong communication and relationships with clients and internal teams, providing regular updates, and proactively resolving any issues that may arise. Additionally, you will be tasked with developing project scope and objectives, planning and tracking project activities, coordinating with cross-functional resources, and ensuring the timely delivery of high-quality pharmacovigilance work. To excel in this position, you should have 3-4 years of previous experience in Pharmacovigilance Project Management, preferably in a service provider or CRO environment. A background in Life Sciences or Biomedical field with a healthcare-related degree such as pharmacology, biology, biotechnology, or veterinary science is essential. You should possess a strong skill set that includes proficiency in various PV processes and regulations, excellent client-management skills, effective communication abilities, time management skills, and attention to detail. Advanced proficiency in verbal and written English, as well as knowledge of MS Office applications, is also required for this role. Join DDReg as a Project Lead Pharmacovigilance and take advantage of this opportunity to contribute meaningfully to the field of pharmacovigilance project management while elevating your career to new heights.,

You have proven experience working in GMP/GLP and scientific environments. You possess basic knowledge of Spectroscopic and Biophysical techniques, Peptide chemistry, as well as peptide characterization. Your expertise lies in at least one of these subjects. Additionally, you have experience in related compound method development and method validation for Peptide drug products using LC-UV and Amino acid analyzer. Hands-on experience with SEC-UV SEC-MALS, SV-AUC, CE, and data interpretation is also one of your strengths in at least one of the techniques and data interpretation. You are skilled in the preparation and review of method development and method validation reports. Knowledge of ICH guidelines and regulatory requirements for peptide products is part of your expertise. As a team player, you are willing to work at different job locations as per the team's requirement. Furthermore, having knowledge of scientific writing will be a plus. Qualifications required for this role include an M. Pharm/M. Sc degree. Amneal is an equal opportunity employer that values diversity and inclusion, ensuring no discrimination based on caste, religion, gender, disability, or any other legally protected status. The Human Resources team at Amneal partners with all aspects of the organization, driving success through effective and innovative people management for both current and future business needs. The team performs key roles such as: - Executive Role: Specialists in all aspects of people management, providing high-level strategic input into key business decisions. - Audit Role: Ensuring compliance with legal requirements and best practice employment policies and procedures across the organization. - Facilitator Role: Partnering closely with different areas of the organization to support, advise, and enhance their ability to meet objectives through highly effective employment practices in areas like Talent Acquisition, Learning and Development, Reward systems, Performance Management, and Health and Wellbeing. - Consultancy Role: Providing expert advice to the organization and its managers on various aspects of workforce management, employee relations, and performance. - Service Role: Keeping the organization informed and equipped to handle developments impacting employment matters, including changes in legislation and labor market characteristics.,

You will be responsible for liaising between various departments such as Planning, Production, Technical Services, Marketing, and Exports. Your roles and responsibilities will include the preparation, review, and implementation of SOPs and STPs. You will be checking all QC related records like analytical reports and logbooks. Additionally, you will be involved in planning and distributing samples for the analysis of Raw Materials, Intermediates, and finished products. You will design and conduct Stability studies as per ICH Guidelines and develop and validate analytical testing methodology used to control raw materials, production intermediates, and final products. Your tasks will also include the preparation and maintenance of working standards with documents, as well as the operation and calibration of laboratory instruments like HPLC, GC, and Spectrophotometer. You will review and approve Raw material, finished product, and Packaging material specifications. Furthermore, you will be responsible for handling customer audits and regulatory authority audits and preparing compliance reports. Troubleshooting of HPLC, GC, and other instruments will be part of your responsibilities. You will manage the laboratory and work towards analytical laboratory improvement, cGMP and GLP compliance, and problem resolution. As the QA/QC Manager, you will be solely responsible for exports and quality-related issues for the unit. You will supervise QC chemists to ensure the smooth working of the department and to guarantee the best quality of products from the production. This is a Full Time position located in Byrathi, Bangalore.,

As a Medical Writer II (Clinical Trial Transparency) at Syneos Health, you will play a crucial role in compiling, writing, and editing medical writing deliverables. Your responsibilities will include mentoring less experienced medical writers, developing various documents such as clinical study protocols, clinical study reports, patient narratives, annual reports, and investigator brochures with minimal supervision. You will review statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency. Collaboration with department heads and staff in data management, biostatistics, regulatory affairs, and medical affairs will be essential to produce high-quality writing deliverables. You will also serve as a peer reviewer to ensure scientific content accuracy, clarity, overall consistency, and proper format. Adherence to established regulatory standards, including ICH-E3 guidelines, Company Standard Operating Procedures, and client standards is paramount. Your role will involve performing online clinical literature searches, maintaining a working knowledge of the drug development process and regulatory guidelines, and continuing professional development to stay informed about regulatory guidance affecting medical writing. In this role, you will be expected to work within budget specifications for assigned projects and communicate any changes to medical writing leadership promptly. Completing required administrative tasks within specified timeframes and performing other work-related duties as assigned will be part of your responsibilities. Some minimal travel may be required, typically less than 25%. To qualify for this position, you should have a Bachelor of Science degree with relevant writing experience or a Bachelor of Arts degree in Social Sciences, English, or Communications with scientific and/or medical knowledge. Proficiency in English grammar, FDA and ICH regulations, and familiarity with AMA style guide is necessary. Effective presentation, proofreading, interpersonal, and leadership skills are essential for this role, along with a team-oriented approach. If you are passionate about making a meaningful impact in the field of medical writing and are eager to contribute to the development of cutting-edge therapies, Syneos Health offers a dynamic and supportive work environment where your contributions will be valued and recognized. Join us in our mission to accelerate customer success and transform lives through innovative medical writing practices.,

Key Responsibilities: Establish, implement, and maintain GMP-compliant quality systems across the API manufacturing unit. Lead and participate in regulatory, internal, and third-party audits ; ensure timely closure of observations and CAPAs. Review and approve validation protocols, master documents, and batch records in line with regulatory requirements. Oversee product release , stability studies, and quality documentation control. Manage and investigate market complaints and implement appropriate corrective actions. Ensure regulatory compliance with international guidelines (e.g., USFDA, EU-GMP, WHO-GMP). Handle vendor audits and qualification for raw materials, packaging materials, and third-party manufacturers. Train and guide the QA team to ensure continuous improvement and inspection readiness. Required Skills & Qualifications: Bachelor's/Master's degree in Pharmacy, Chemistry, or a related field. 812 years of experience in QA roles within API manufacturing , including managerial experience. Strong understanding of GMP , ICH guidelines , and international regulatory frameworks. Proven experience with regulatory inspections (USFDA, MHRA, EUGMP, etc.). Excellent leadership, documentation, and communication skills.

The Associate Medical Reviewer position at Novo Nordisk Global Business Solutions (GBS) India, specifically in the Centralised Monitoring Unit (CMU) department in Bangalore, Karnataka, IN, offers a challenging and dynamic environment for individuals who are motivated by working closely with key stakeholders and strive for continuous improvement in their career objectives. As an Associate Medical Reviewer, you will play a crucial role in conducting comprehensive medical reviews of clinical trial data across various therapy areas within the drug development portfolio. Your responsibilities will include ensuring the highest quality and consistency of medical data, with a strong emphasis on patient safety, protocol adherence, and compliance with Good Clinical Practice (GCP), ICH guidelines, local regulations, and Standard Operating Procedures (SOPs). You will collaborate closely with study team members such as Data Managers, Trial Managers, and Medical Specialists throughout the trial process, providing timely updates on the status of medical reviews and escalating any issues to maintain trial integrity and compliance. In this role, you will also be responsible for contributing to or participating in trial planning activities related to medical review, performing quality checks for medical reviews, clarifying and resolving issues of medical concern and inconsistencies in clinical trial data with staff at investigational sites, presenting findings of Medical Review to relevant Medical Specialists, documenting medical reviews in the sponsor TMF, and ensuring close collaboration with relevant study group members. To be successful in this role, you must hold a graduate degree in Medicine, preferably an MBBS or MD in other clinical specialties, along with relevant experience in clinical patient management or clinical research. Additionally, having 1-2 years of relevant experience in Clinical Drug Development, project management experience, a solid understanding of ICH guidelines and GCP principles, proficiency in computer applications, strong grasp of medical terminology and clinical trial processes, demonstrated analytical skills, and exceptional proficiency in written and spoken English are essential qualifications. Novo Nordisk is a leading global healthcare company with a strong legacy of driving change to defeat serious chronic diseases. By joining Novo Nordisk, you will have the opportunity to contribute to impacting millions of patient lives daily and be part of a team that is committed to making a difference in the world. If you are looking to be part of a collaborative and inclusive culture that celebrates diversity and values the unique skills and perspectives of its employees, then consider applying for the Associate Medical Reviewer position at Novo Nordisk GBS India. To apply for this position, please upload your CV online by the deadline of 29th July 2025. Novo Nordisk is committed to an inclusive recruitment process and equality of opportunity for all job applicants.,

You will be joining our ARD team in Udaipur as an ARD Chemist / Scientist. Your main responsibilities will include method development and validation, impurity profiling, and instrumental analysis to assist our Synthesis R&D and quality operations. Your key responsibilities will include developing HPLC, GC, and LC-MS analytical methods for monitoring in-process reaction samples, validating HPLC methods suitable for AMV, performing impurity profiling of APIs and intermediates, identifying and characterizing impurities using advanced techniques like mass spectrometry, ensuring all analytical instruments are well-maintained, performing regular calibration and documentation of analytical instruments, maintaining proper records as per regulatory and internal quality standards, and supporting the preparation of SOPs, protocols, and technical reports. To excel in this role, you should possess a strong knowledge of HPLC, GC, and LC-MS techniques, have experience in method development and impurity profiling, be familiar with ICH guidelines and regulatory requirements, be proficient in analytical software like Empower/Chromeleon, and have good documentation and communication skills.,

As an ARD Chemist / Scientist at our Udaipur location, you will be a key member of our ARD team, responsible for method development and validation, impurity profiling, and instrumental analysis to support our Synthesis R&D and quality operations. Your primary responsibilities will include developing and validating HPLC, GC, and LC-MS analytical methods for monitoring in-process reaction samples, as well as developing HPLC methods suitable for Analytical Method Validation (AMV) and transfer to QC. You will also be tasked with performing impurity profiling of APIs and intermediates, identifying and characterizing impurities using advanced techniques like mass spectrometry, and ensuring that all analytical instruments are maintained in optimal working condition through regular calibration and documentation. In addition, you will play a crucial role in maintaining proper records as per regulatory and internal quality standards, supporting the preparation of SOPs, protocols, and technical reports, and ensuring compliance with ICH guidelines and regulatory requirements. To excel in this role, you must possess a strong knowledge of HPLC, GC, and LC-MS techniques, along with experience in method development and impurity profiling. Familiarity with analytical software such as Empower/Chromeleon, good documentation, and communication skills are also essential for success in this position.,

As a Safety & PV Specialist I-Japanese at Syneos Health in Pune Office, your primary responsibility will be to ensure accurate and timely processing of Individual Case Safety Reports (ICSRs) in compliance with Standard Operating Procedures (SOPs) and regulatory requirements. You will play a crucial role in maintaining safety tracking, performing data entry into safety databases, coding events and medical history, and compiling narrative summaries. Additionally, you will be involved in the validation and submission of xEVMPD product records, management of duplicate ICSRs, and activities related to SPOR / IDMP. Your role will also include conducting literature screening and review for safety, maintaining drug dictionaries, and ensuring compliance with global drug regulations, Good Clinical Practice (GCP), and ICH guidelines. You will collaborate with internal and external stakeholders to generate expedited safety reports, participate in audits, and apply regulatory intelligence to safety reporting activities. At Syneos Health, we are committed to fostering a culture of diversity and inclusion where every individual feels valued and respected. You will have the opportunity to develop your skills through career advancement opportunities, supportive management, and comprehensive training programs. Join us in our mission to accelerate the delivery of therapies and make a difference in the lives of patients worldwide. To excel in this role, you should have a strong attention to detail, the ability to work effectively in a team environment, and a commitment to maintaining high standards of quality and compliance. Your contributions will be instrumental in supporting clinical trials and post-marketing programs, ensuring the safety and well-being of patients and enhancing the overall success of our organization. If you are passionate about making a meaningful impact in the field of biopharmaceutical solutions and are eager to collaborate with like-minded professionals, we invite you to explore the exciting opportunities available at Syneos Health. Join us in our mission to transform lives and drive innovation in healthcare. For more information about Syneos Health and our global impact, please visit our website at http://www.syneoshealth.com.,

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.,

Assist with data management leadership on a large/global project or multiple projects with responsibility for Thesaurus Management and technical oversight of all dictionary coding activities for the delivery of medical coded data according to Fortrea/client quality and integrity specifications, project timelines, and budgets. Develop and maintain a close liaison with project Lead Data Reviewer, core team members, and Clinical Lead Data Managers as appropriate. Perform the clinical medical data coding aspects of assigned projects on a global basis independently. Work with the Manager to aid in personal career development, interpersonal skills, and achievement of competency standards. Assist in the identification and implementation of solutions to project data management coding issues and concerns. Serve as the project liaison including provision of project-specific coding status. Assist in the review of Data management plan and/or Study specific Dictionary Coding Conventions and Specifications. Interact and collaborate with other project and specialty team members to support the set-up, maintenance, and closure of the data management aspects of the project. Maintain coding technical competencies via participation in internal and external training seminars. Support project staff on achieving client satisfaction through delivery of quality medical coded data, on-time, and on-budget. Assist in identifying areas for process improvement, efficiency improvement, and implement solutions on assigned projects. Assist with the dictionary verification of Fortrea standard dictionaries and client dictionaries in a timely manner. Perform dictionary verification on assigned projects. Review literature and research technologies/procedures for improving global thesaurus management practices. Perform all other duties as needed or assigned. Qualifications: - University/college degree in life science, pharmacy, or related subject preferred, or certification in a related allied health profession. - Fluent in English, both written and verbal. Experience: - Minimum three (6-8) years relevant work experience in clinical data management with 2 years clinical data coding experience. - In-depth knowledge of medical coding process and various coding tools. - Demonstrated interpersonal skills. - Excellent oral and written communication and presentation skills. - In-depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations. - Broad knowledge of thesaurus management process. - Knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs. - Knowledge of effective clinical data management practices. Preferred Qualifications: - MedDRA Certified. - Knowledge of Fortrea and the overall structure of the organization. - Thorough knowledge of Fortrea standard operating procedures and work instructions. For more information about EEO & Accommodations requests, please refer to the company's policies.,

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.,

Review Site Visit Reports (SVRs) to ensure they meet or exceed quality standards and support goals of quality, subject safety, data integrity and regulatory compliance. Use tools and techniques to ensure the efficient and effective review of Site Visit Reports and their associated attachments, in compliance with IQVIA SOP, ICH/ GCP guidelines, and protocol requirements Essential Functions Oversee a caseload of SVRs for assigned studies, ensuring compliance to the protocol, processes, timelines, IQVIA/applicable SOPs, and GCP guidelines. Review SVRs to ensure findings requiring corrective and /or preventative action plans are documented and followed up to resolution, to ensure high quality reports. Participate on the project team for all SVR review activities and identifies and escalate CRA and /or site issues, relevant trends, and related risk factors to the project team and appropriate parties in a timely manner to optimize quality of project delivery. Provide guidance to Clinical Project Managers (CPMs) at project start-up and throughout the study and partner with the project team members to decrease the level of corrections/additions needed on reports by providing insight and training of the SVR annotations. Identify and track the project team compliance to SOPs for submission and approval of the SVRs through communication with the CRAs and line managers. Participate in meetings with project team to discuss any SVR review issues illustrative of quality/performance deficiencies across PIs/sites and CRAs. Assist with identification of the trends emerging from the Issue Escalation Log. Provide coaching to CRAs to decrease the level of corrections/additions needed on reports. Provide quality improvement support such as quality checks, data trending, providing back up support and mentoring and coaching of junior staff members. May take on special project assignments related to function/corporate initiatives. Qualifications Bachelors Degree Healthcare or other scientific discipline or educational equivalent Req 7-8 years of Clinical Research experience, including a minimum of 3 to 4 years on-site monitoring experience Req Or Equivalent combination of education, training and experience. Req Strong knowledge of and skill in applying, applicable clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Through knowledge and understanding of the Clinical monitoring processes and sound knowledge of clinical trial systems and applications Demonstrated skill in understanding and executing complex study designs as well as multiple studies Strong written and verbal communication skills. Effective time management and organizational skills, and the ability to manage competing priorities Ability to work independently with good analytical and problem solving skills Demonstrated ability to work across cultures and geographies with a high awareness and understanding of cultural differences High quality orientation, with a focus on attention to detail Ability to establish and maintain effective working relationships with coworkers, managers and clients. Fluent in English, both spoken and written.

We are seeking a meticulous and experienced Manager Quality Control to lead and enhance our quality control operations at Synnat Pharma Private Limited. In this pivotal role, you will be instrumental in overseeing all aspects of quality control, ensuring adherence to Good Laboratory Practices (GLP), and maintaining a robust Quality Management System (QMS). Your expertise will be crucial in driving Analytical Method Development, managing CAPA and Change Control processes, and upholding Data Integrity standards. You will lead a team of QC analysts, providing training and mentorship to foster a culture of excellence. The ideal candidate will possess a strong understanding of ICH Guidelines and Regulatory Compliance, with hands-on experience in GC and HPLC. This role demands a proactive approach to QC process improvement, meticulous QC documentation, and the ability to conduct thorough analytical data reviews. Job Details: Industry: Active Pharmaceutical Ingredient (API) Department: Quality Control Role: Manager - Quality Control Location: Visakhapatnam Compensation: 12 -15 LPA Experience Required: 10 - 15 years Employment Type: Full-time Required Qualification: Bachelor's degree in Chemistry, Pharmacy, or a related field Responsibilities: Analytical Method Development and Validation Lead the development, validation, and transfer of analytical methods for API testing in compliance with ICH and regulatory requirements. Review validation protocols and reports, ensuring accuracy and completeness. Troubleshoot analytical challenges and provide technical guidance. Collaborate with AR&D to optimize methods for both new and existing products. Ensure complete documentation of method development and validation activities. Quality Management System (QMS) and Compliance Maintain and improve the QMS to comply with regulatory standards (US FDA, EU GMP). Oversee CAPA and Change Control processes to address quality deviations. Conduct internal audits to ensure procedural compliance and identify improvement areas. Ensure adherence to Data Integrity principles across QC operations. Serve as the key QC contact during regulatory inspections and audits. Laboratory Operations and Equipment Management Supervise daily QC laboratory operations and ensure efficient sample testing. Oversee calibration and maintenance of laboratory instruments (GC, HPLC). Monitor lab environmental conditions and implement corrective actions where needed. Ensure sufficient availability of reagents, standards, and consumables. Implement lab safety procedures and optimize workflows to improve turnaround time. Team Leadership and Performance Management Lead and mentor QC analysts, fostering a collaborative and improvement-driven culture. Conduct performance evaluations and provide development-focused feedback. Design and deliver technical training programs to enhance team capability. Assign responsibilities to ensure a balanced workload and accountability. Address employee concerns and promote a positive, inclusive work environment. Data Analysis and Reporting Oversee review and interpretation of analytical data for compliance and reliability. Approve QC reports including Certificates of Analysis (CoAs). Identify trends and take proactive measures to address quality concerns. Present QC metrics and insights to management and cross-functional stakeholders. Maintain accurate records and use statistical tools to evaluate data. General Expectations and Past Experiences: Strong understanding of pharmaceutical QC principles and global regulatory standards (US FDA, EU GMP). Demonstrated expertise in analytical method development and validation with hands-on experience in GC and HPLC. Proven track record of maintaining QMS aligned with ICH guidelines. Experience managing CAPA, Change Control, and Deviation processes. Deep commitment to Data Integrity and documentation compliance. Strong leadership skills with a track record of mentoring high-performance teams. Excellent interpersonal, communication, and analytical problem-solving abilities.

We are seeking a meticulous and experienced Executive/Sr. Executive to spearhead chromatographic analysis and data review at Synnat Pharma Private Limited, a rapidly growing API manufacturer. In this pivotal role, you will be responsible for ensuring the accuracy, reliability, and compliance of analytical data generated within our QC laboratory. Your expertise will be crucial in adhering to stringent regulatory standards, including ICH guidelines and pharmacopeial requirements, while contributing to the overall quality and integrity of our pharmaceutical products. The ideal candidate will possess a strong understanding of HPLC and GC systems, coupled with proficiency in Empower CDS and a deep commitment to data integrity and GLP/GMP principles. This role demands a proactive individual capable of troubleshooting analytical issues, leading OOS/OOT investigations, and implementing effective CAPA measures. You will collaborate closely with cross-functional teams to maintain a robust Laboratory QMS and ensure seamless method of transfer and validation processes. If you are passionate about pharmaceutical sciences and dedicated to maintaining the highest standards of quality in API manufacturing, we encourage you to apply. Job Details: Industry: Active Pharmaceutical Ingredient (API) Manufacturing Department: Quality Control Role: Executive/Sr. Executive Location: Visakhapatnam Compensation: 4,00,000 to 8,00,000 INR per annum Experience: 4-7 years Qualification: Bachelor's or Master's degree Chemistry, or a related field Employment Type: Full-time Responsibilities: Chromatographic Analysis and Data Review Perform chromatographic analysis of raw materials, in-process samples, and finished products using HPLC and GC techniques, ensuring compliance with established test procedures and pharmacopeial requirements. Review chromatographic data generated by other analysts for accuracy, completeness, and compliance with data integrity and GDP. Troubleshoot HPLC and GC systems, resolving issues to ensure reliable instrument performance. Participate in method validation and transfer activities in line with regulatory expectations. Analyze stability samples and maintain data integrity in accordance with ICH guidelines. Prepare reports summarizing analytical results and findings. Quality Control and Compliance Implement and maintain a robust Laboratory QMS as per GLP, GMP, and internal quality standards. Lead OOS and OOT investigations and implement corrective actions to prevent recurrence. Manage and document CAPA activities effectively. Ensure data integrity through robust controls and secure data handling practices. Participate in audits and address regulatory observations. Maintain accurate documentation as per GDP guidelines. Laboratory Operations and Maintenance Oversee calibration and maintenance of HPLC and GC systems. Manage lab supplies and ensure proper storage and inventory control. Maintain a clean and compliant lab environment. Train junior staff in instrumentation, methods, and data practices. Develop SOPs and contribute to continuous improvement of test procedures. Support cross-functional teams in resolving quality-related issues. Stakeholder Management and Reporting Collaborate with R&D, production, and regulatory affairs teams. Communicate analytical findings effectively for decision-making. Prepare periodic reports for management summarizing QC trends. Participate in regulatory inspections and audits. Coordinate with external vendors for analytical services. Represent the QC department in internal/external meetings. General Expectations and Past Experiences: Possess a Bachelor's or Masters degree in Pharmaceutical Sciences, Chemistry, or a related field. Have 4-7 years of experience in a pharmaceutical QC lab, preferably API-focused. Demonstrate expertise in HPLC and GC, including troubleshooting and method validation. Exhibit a strong understanding of GMP, GLP, ICH, and pharmacopeial compliance. Proficiency in Empower CDS is essential. Strong skills in data review, OOS/OOT handling, CAPA, and documentation. Excellent team collaboration, problem-solving, and communication abilities.

We are looking for a meticulous Executive/Sr. Executive to spearhead regulatory submissions and review at Synnat Pharma Private Limited. In this pivotal role, you will be instrumental in ensuring our API manufacturing processes adhere to global pharmaceutical regulations. Your expertise will be essential in compiling, reviewing, and submitting comprehensive regulatory documentation to various health authorities, including the US FDA, EMA, and CDSCO. You will manage regulatory inspections, handle queries, and lead the preparation of DMF filings. The ideal candidate will possess a deep understanding of regulatory guidelines, ICH guidelines, and relevant pharmacopeias (USP, EP, BP), coupled with experience in process validation and variation submissions. Your responsibilities will extend to maintaining robust electronic document management systems (EDMS) and ensuring manufacturing records align with regulatory requirements. This position demands a proactive individual with excellent communication skills to effectively liaise with regulatory agencies and internal stakeholders, ensuring Synnat Pharma maintains its commitment to quality and compliance in the pharmaceutical industry. Job Details: Industry: Pharmaceutical (API Division) Department: Regulatory Affairs Role: Executive/Sr. Executive Location: Visakhapatnam Compensation: 5,00,000 - 10,00,000 INR per annum Experience: 5-9 years Qualification: Bachelor's degree in Pharmacy, Chemistry, or related field Responsibilities: R egulatory Submissions & Documentation: Prepare, review, and submit comprehensive regulatory dossiers and technical documentation for API products to various health authorities (US FDA, EMA, CDSCO). Manage the compilation, archiving, and tracking of all regulatory documentation using electronic document management systems (EDMS). Ensure all regulatory submissions are accurate, complete, and compliant with current regulatory guidelines and requirements. Maintain up-to-date knowledge of changes in pharmaceutical regulations and guidelines and communicate these changes to relevant stakeholders. Prepare and manage Drug Master File (DMF) filings, renewals, and updates, ensuring timely submissions and compliance. Coordinate with cross-functional teams (manufacturing, quality control, R&D) to gather necessary data and documentation. Regulatory Compliance & Inspections: Lead and manage regulatory inspections conducted by health authorities, ensuring preparedness and compliance. Develop and implement corrective and preventive actions (CAPA) in response to inspection findings and regulatory queries. Conduct internal audits to ensure compliance with pharmaceutical regulations and quality standards related to API manufacturing. Review manufacturing records and analytical data to ensure compliance with regulatory requirements and guidelines. Monitor and ensure adherence to pharmacopeias (USP, EP, BP) and ICH guidelines in API manufacturing processes. Maintain a thorough understanding of API manufacturing regulatory compliance. Regulatory Communication & Liaison: Act as the primary point of contact for communication with regulatory agencies regarding submissions, queries, and inspections. Prepare and manage responses to regulatory queries and deficiency letters, ensuring timely and accurate information. Liaise with internal stakeholders to address regulatory issues and provide guidance on compliance matters. Communicate regulatory updates and changes to relevant departments. Cultivate and maintain positive relationships with regulatory agencies. Provide support and guidance to cross-functional teams on regulatory expectations. Variation & Renewal Management Prepare and submit variation applications for changes to approved API manufacturing processes and formulations. Manage the renewal process for existing regulatory approvals, ensuring timely submissions and compliance. Assess the impact of proposed changes on regulatory filings and ensure appropriate documentation is prepared. Track the status of variation and renewal applications and communicate updates to stakeholders. Ensure all variations and renewals align with current regulatory guidelines. Maintain a comprehensive record of all variations and renewals submitted General Expectations and Past Experiences: Possess a Bachelor's degree in Pharmacy, Chemistry, or a related scientific field. Demonstrated experience (6-9 years) in regulatory affairs within the pharmaceutical industry, specifically in API manufacturing. Proven expertise in preparing and managing DMF filings and regulatory submissions for global health authorities (US FDA, EMA, CDSCO). Strong knowledge of pharmaceutical regulations, ICH guidelines, and pharmacopeias (USP, EP, BP). Experienced in regulatory inspections and responding to regulatory queries and deficiency letters. Proficient in EDMS and other relevant documentation systems. Excellent communication, interpersonal, and problem-solving skills with the ability to work cross-functionally.

Job description : Lead the preparation and review of aggregate safety, risk management, signal detection, and benefit-risk evaluation reports Demonstrate the ability to independently manage the production of safety deliverables, including those involving complex data analyses or important safety issues Act as a technical lead of the medical writing teams across projects and provide guidance and expertise for developing high-quality scientific content as required for various safety deliverables Establish good client communication and coordination within writing teams to manage stakeholder expectations and resolve any issues surrounding project/report deliverables Contribute to scientific publications and represent the company at scientific meetings and conferences Work with the project management team to implement quality and process improvement initiatives Foster excellent working relationships with all clients, both internal and external, with the highest quality of service in a cost-effective manner on time, every time. Summary of Responsibilities: Write and review various safety reports for global regulatory submissions for clients, including but not limited to Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Development Safety Update Report, Clinical Overviews, Medical Device reports, and other documents as assigned. Lead the end-to-end process of report production and ensure the required quality standards and key timelines are met. Provide oversight to co-authors or team of writers as applicable and be accountable for the quality of their work/contributions. Act as the primary point of contact for the client for all report management activities. Engage in client communication to manage stakeholder expectations, present anticipated challenges, propose remediation, and escalate unresolved issues impacting deliverables at an individual report or project level. Author/review RMPs, ad hoc reports, Benefit-Risk Evaluation reports, supporting documents for label updates, reports of effectiveness of risk minimization measures or enhanced pharmacovigilance activities. Lead/participate in various steps of the signal management process. Provide inputs for developing signal strategies and retrieval of data from safety databases, scientific literature, and other sources, as required. Author/review signal evaluation/management reports (ad hoc and periodic) and safety issue analysis reports. Participate in safety/benefit-risk review meetings with clients, discuss results and conclusions from signal/safety analysis, and in collaboration with the safety physician, propose label updates and other risk mitigation measures, as needed. Draft responses (or parts thereof) to health authority questions or feedback and collaborate with cross functional stakeholders in the management and tracking of such feedback. Develop abstracts, posters, manuscripts, and other documents for scientific publication or presentation at conferences or pharmacovigilance forums. Prepare medical information responses for HCPs. Act as a writing coach, provide regular quality feedback, conduct training, and share best practices with associates for promoting the use of clear and concise writing and adherence to style guides, as applicable. Support project management activities such as maintenance of project schedules and tracking of metrics and compliance. Contribute to business development activities, including estimation of resource requirement and responding to RFPs. Create and update labels, e.g. Core Data Sheets, USPI, centralized SPC s, Med Guides. Conduct literature reviews, formulate and execute search strategies, including those for complex topics or research questions. Implement and promote use of consistent, efficient, and quality processes to meet timelines and deliverables according to requirements and standard operating procedures and assume accountability for the deliverables. Ensure compliance of operations with governing regulatory requirements. Create, maintain, and assume accountability for a culture of high customer service. Perform any additional activities per project requirement or at the manager s discretion upon completion of relevant training. And all other duties as needed or assigned. Qualifications (Minimum Required): Minimum of first degree in life sciences (or equivalent). Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required): At least 5-7 years of experience in the pharmaceutical industry, with at least 4 years of it in medical writing. Excellent command of written and spoken English. Good written and verbal communication skills. Knowledge of MS Office. Good organizational and time management ability. Excellent interpersonal and leadership skills. Scientific or clinical research or medical writing experience desirable. Good understanding of regulatory requirements, good Pharmacovigilance practices and ICH GCP guidelines.

We are looking DM RA with leading pharma company in Thane. Experience in Injectable regulatory affairs pre approval & post approval experience is must. Regulatory Submissions New Project Assignment This role involves the assignment and management of new projects for regulatory submissions, playing a pivotal part in the preparation and timely submission of high-quality regulatory documents across the US, EU, UK, and Emerging Markets. The position demands a strong understanding of global regulatory requirements, excellent communication skills, and effective cross-functional collaboration to ensure successful outcomes. Educational Qualifications Bachelor’s or Master’s degree in Pharmacy, Chemistry, or a related scientific discipline Diploma in Regulatory Affairs preferred Technical and Professional Expertise Demonstrated experience in regulatory affairs with a focus on submissions for the US, EU, UK, and Emerging Markets Solid understanding of ICH guidelines, ASEAN CTD requirements, and eCTD publishing standards Practical experience in the preparation, review, and submission of regulatory documents Familiarity with Quality by Design (QbD) principles and data trend analysis Experience 5 to 10 years of relevant experience in regulatory affairs Key Personal Attributes Excellent verbal and written communication skills Strong interpersonal and collaboration abilities Capable of working independently and managing multiple projects simultaneously Domain and Functional Competencies In-depth knowledge of international regulations (e.g., FDA, EMA, ICH) Up-to-date with evolving regulatory frameworks and compliance requirements Proficient in compiling,reviewing, and submitting comprehensive regulatory dossiers Ensures completeness, accuracy, and adequacy of all documents required for product approvals