54 Ich Guidelines Jobs - Page 2

The ideal candidate for this role should possess a minimum education qualification of M. Pharmacy. You will be responsible for handling regulatory activities such as CTD dossier preparation, query resolution, and ensuring compliance with ICH guidelines and current regulatory standards. Your primary market focus will be on the Africa market, specifically in regions like Zazibona, South Africa, East Africa (Kenya, Tanzania, Ethiopia, etc.), and FWA. Your key responsibilities will include: - Preparation and submission of new dossiers - Conducting gap analysis of dossiers for completeness - Compiling dossiers in eCTD format for submission to various regulatory authorities - Coordinating dossier ...

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. You...

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...

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...

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 t...

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 th...

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...

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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 respons...

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 ...

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 inclu...

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 ...

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 th...

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 pati...

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 instrume...

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 al...

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, ...

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 envir...

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 i...

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 findin...

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 re...

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 ...

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 dee...

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 wit...

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 publ...