176 Ich-Gcp Guidelines Jobs - Page 7

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Bachelor of Physiotheraphy/BSc. Nursing Years of Experience: 1 to 3 years 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.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.In this role, you will be expected to create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for? Adaptable and flexible Ability to work well in a team Agility for quick learning 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 Qualifications Bachelor of Pharmacy,Bachelor of Physiotheraphy,BSc. Nursing

medpeace lifesciences is looking for Post : Clinical Research Coordinator to join our dynamic team and embark on a rewarding career journey. We are seeking a highly motivated and detail-oriented Researcher to join our team The Researcher will be responsible for conducting thorough research, analyzing data, and providing insights to support various projects and initiatives within the organization Responsibilities:Conduct in-depth research on a wide range of topics related to the organization's goals and objectives Collect and analyze data from various sources, including online databases, surveys, and interviews Summarize research findings and present them in a clear and concise manner Collaborate with team members to identify research needs and prioritize tasks accordingly Stay up-to-date with industry trends and best practices in research methodologies Assist in the preparation of reports, presentations, and other materials based on research findings Provide support to other departments as needed, including assisting with proposal writing, grant applications, and program evaluations Maintain accurate records of research activities and findings

Assist with regulatory compliance tasks for the firm. Research and stay updated on relevant financial regulations. Review client documentation and ensure adherence to KYC/AML procedures. Prepare reports and presentations on compliance topics. Maintain accurate records of compliance activities. Skills Strong attention to detail and accuracy. Ability to understand and interpret complex regulations. Excellent research and problem-solving skills. Strong work ethic and commitment to ethical practices.

Dear Job Seeker's..!! Greetings for the day! We have an exciting job opportunity for you with our company. Please review the following details and revert back if interested. Job Role:- Clinical Project Manager (CDM) Experience:- 9 to 16 Years Current & Preference Location: Hyderabad, Bangalore & Mumbai Work Location: Hyderabad Main Duties: Management of one or more projects with a focus on delivery of the scope on time, within budget and with a high-quality outcome Project Manager in their project delivery needs and to ensure that all study deliverables are tracked and that the study documentation is current Meet the management of client expectations Helping monitor project scope, timelines, budget & milestones, issues & risks for a variety of projects Helping monitor project financials, budget tracking and accuracy of invoicing Creation and maintenance of accurate and current study documentation Raising work requests to other departments for tasks to be completed Capture minutes/action items during client and internal status meetings Problem/issue tracking and work with the Consultants/Others to ensure timely resolution Provide pro-active communication with all internal and external stakeholders Assure compliance with the organization standard project management methodologies and the SOPs Skills/Requirements: Basic understanding of clinical research (pharma, device and/or biotech sectors) and of Clinical Research SaaS technology. Able to demonstrate good verbal/written communication combined with some organizational skills. Exhibit time management skills combined with strong collaboration and team-building awareness Experience in supporting project teams and meeting project timelines would be advantageous Self-motivated and able to assume responsibility in a professional manner Is proficient in the use of all relevant EDC/CDM systems Can demonstrate some computing skills and has experience with MS Office suite, Word, Excel and PowerPoint Can demonstrate presentation skills.

Roles and Responsibilities Responsible for Analytical Method Validation. Responsible for HPLC/GC instrument handling. Responsible for Daily review of Analytical balance and Daily Temperature monitoring. Responsible to follow analytical procedures and generate online raw data. Responsible for Stability Studies and Analysis. Responsible to operate and analyze of raw materials, In Process, cleaning samples, samples for vendor qualification, Stability samples, standard and Finish product Samples and instrumental method (HPLC / UPLC / GC) and to perform analysis of process validation. Responsible for Daily verification of analytical balance and daily temperature monitoring. Online entry in logbooks of instrument, column, working standard, chemical inventory whenever use. Responsible for in process data review in night shift. Finished product sample receive, entry taken in register and maintain daily status. Responsible to follow all the Standard operating procedures, to give Instructions for housekeeping, cleaning and maintaining the laboratory area. Responsible to follow all the analytical procedures and generates online raw data, Chromatograms, calculation sheets and charts with reviewer signature. Responsible to control and maintain records like protocols, Specification, Standard test procedure, Analytical work record, Standard operation procedure, In- process analysis records, usage log books and status labels during day to day Analysis. Responsible to perform calibration and maintain its records. Responsible to Prepare and maintain record of finished product. Responsible to maintain record of chemicals, glass wares and other lab items of department. Responsible for cleaning, maintenance, and daily calibration of specified instruments. Responsible to maintain records and qualification of primary standards, reference standards and working standards. Responsible for reporting to senior if any abnormality observed during analysis and perform for the out of specification and to investigate the OOS (Out of specification) or OOT (Out of trend)if found and Responsible for maintaining QMS related documents. Responsible to follow various EHS (Environment Health and safety) guideline and use appropriate PPEs (Personal protective equipments) . . Desired Candidate Profile Candidate Should be from Pharma background Candidate Should have excellent knowledge of ICH Guidelines Prefer Who can work in a shift and willing to relocate in Navsari, Gujarat Candidate should have Work Accuracy.

Purpose of this position: This position is responsible for daily overall functioning of the R & D laboratory, provide guidance perform experiments and prepare documentation for R & D and Pilot Plant. Roles & Responsibilities: To Plan & perform Lab experiments for Process development as per Guideline To modify & optimise lab process for plant scale-up batches To keep record of all experiment taken To prepare & record the documents of R&D & Pilot plant batch work on day to day To execute and assist demo batches to plant chemist To Deliver the project/Product as per committed timeline To provide online support to production dept. for trouble shooting To look after glass wares, lab wares / instruments, calibration & maintenance. To Prepare the process write up with document team. To submit tech transfer document to QA along with PDR To follow the guideline and SOPs of R&D department To create healthy working atmosphere in R&D. To train & guide trainee chemist Be always careful about chemical handling by following safety measures and also give training to juniors To coordinate with ADL, Plant and maintenance. To take work as per allocation for officers and operators. Responsible to develop the robust, cost- effective and commercialized process. Responsible for scale up at pilot and plant level. Preferred candidate profile Minimum M. Sc required. Minimum 4 to 6 years of relevant experience required Candidate should be Master's in chemistry with sound knowledge of Organic chemistry and ICH guidelines with 6 to 8 years of research experience. Should have experience of handling 2 to 3 scientist, daily experiment planning and communicate with other department.

Skill required: Clinical Data Services - Clinical Data Management Designation: Clinical Data Svs Specialist Qualifications: Bachelor of Pharmacy Years of Experience: 7 to 11 years 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 Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. The role may require you to identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The role may also need expertise in managing clinical data management projects. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualifications Bachelor of Pharmacy

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy Years of Experience: 1 to 3 years Language - Ability: English(International) - Advanced What would you do? Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases. What are we looking for? Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases. 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 Qualifications Bachelor of Pharmacy

We are seeking a highly organized and detail-oriented Clinical Trial Coordinator (Fresher) to join our dynamic clinical research team. In this role, you will play a crucial part in ensuring the successful execution of our clinical trials from start to finish. You will collaborate with a multidisciplinary team of researchers, investigators, and study personnel to coordinate all aspects of clinical trial operations. Key Responsibilities: Study Coordination: Coordinate the day-to-day activities of assigned clinical trials, ensuring adherence to protocols, timelines, and regulatory requirements. Site Management: Assist in site selection, initiation, monitoring, and close-out activities. Documentation: Maintain accurate and complete study records, including case report forms, source documents, and regulatory binders. Communication: Facilitate effective communication between study sites, sponsors, investigators, and internal team members. Data Management: Ensure timely and accurate data collection, entry, and query resolution. Regulatory Compliance: Ensure compliance with all applicable regulations, guidelines, and standard operating procedures. Patient Recruitment: Support patient recruitment and retention efforts. Training: Provide training and support to study staff on study protocols and procedures. Quality Assurance: Participate in quality control activities and internal audits. Qualifications and Skills: Education: Bachelor's degree in life sciences, nursing, or a related field. Experience: Fresher or recent graduate with a strong interest in clinical research. Knowledge: Basic understanding of clinical research principles and Good Clinical Practice (GCP). Skills: Excellent organizational, communication, and interpersonal skills.

Role & responsibilities: Prepare and manage regulatory submissions (e.g., Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), marketing authorization submissions). Ensure clinical trials are conducted in compliance with regulatory requirements, including Good Clinical Practice (GCP), ICH guidelines, and local regulations. Track regulatory timelines and manage submission deadlines for new drug applications, clinical trials, and so on. Preparation and review of clinical study reports along with preparation of Bio summary/summary tables, BTIF and other regulatory documents with the study data. Adhering to GCP to meet regulatory requirements, Verification of deviations from the Protocol, SOPs, GCP and other applicable requirements and taking preventive action and corrective action to prevent recurrence. Preparation of audit reports and suitable corrective and preventive action plans. To have experience in the Ethics Committee related activities. To liaison with Local Drug Authorities (DCGI/CDSCO) for regulatory approvals of Test Licenses, Amendments, for conducting BA/BE clinical studies in India. Timely notification to DCGI/CDSCO for study related updates Communicate with regulatory agencies to clarify requirements and resolve issues related to clinical trial approvals and submissions. Manage responses to regulatory queries and facilitate interactions between the client and regulatory bodies. To search literature on healthy population to support BA/BE NOC application To liaise CBN for regulatory approvals for conducting clinical studies in India. To coordinate with global regulatory authorities for regulatory strategic for various products and services Proactive co-ordination of all the necessary activities required regulatory submission. Preferred candidate profile: Education : Bachelor's degree in life sciences, pharmacy, or related field (Masters or advanced degree preferred). Experience : 5+ years of experience in regulatory affairs within a CRO or pharmaceutical/biotech industry, with at least 2 years in a managerial role. Knowledge : In-depth knowledge of global regulatory guidelines (FDA, EMA, ICH), clinical trial regulations, and submission processes. Interested applicants can apply with their updated profile or Can send to email to hr@qpsbioserve.com

Greetings from You & I Consulting! You & I Consulting has always been in the spotlight for getting placed in 64+ MNC's PAN India. Hirings for MNC : - Great Opportunity in Giant MNC .Grab the Opportunity to grow and explore We are hiring for: Medical Writer CTC : upto 17 LPA Mode : Work From Office Location- Mumbai, Pune, Bengaluru Preferred experience for the role: • Overall ~5 years of authoring/editing experience in medical writing domain across different therapeutic areas in clinical documents including clinical study protocol, pediatric investigation plan, informed consent document, clinical study report, investigators brochure, clinical summary of pharmacology, clinical overview (efficacy and safety), briefing package/pre-meeting package preferred • Good knowledge of clinical research domain, ICH GCP principles, Common Technical Document (CTD) structure and regulatory requirements • Experience in preparation of clinical documents necessary for national and international regulatory submissions to the US, European and other regulatory agencies • Computer Literate: Knowledge of MS Word, PowerPoint, Adobe Acrobat, MS Excel, etc Responsibilities: • Setting, discussing and meeting expectations of the document during kick off and subsequent meetings Lead the authoring/editing of clinical documents, as mentioned above. Ensure adherence to established processes, timelines, regulatory guidelines and applicable standards, styles, guidelines Perform quality review of the clinical documents within established timelines with adherence to applicable guidelines, templates, and processes Ability to effectively and proactively communicate with internal and external stakeholders, including authors and key opinion leaders as appropriate (including problem-solving and resolution of issues) • As required, take on functional role and responsibilities of the role of Documentation Lead o Lead PDRD deliverables for project and act as first point of contact for any information that is required for content/document preparation Ensure alignment and content re-use across documents for a product Onboard lead document writers on document content alignment and timelines. Provide required source documents incl. information pertaining to study documentation, relevant project contacts (authors, reviewers), developmental strategy Actively participate in Regulatory Affairs Functional or other cross functional team meetings Review content of document prior to finalization to ensure high quality prior to initiation of author review or Expert Team Review Perks and benefits: ONLY 5 Days Work CAB Fecility Medical Benefits To Apply Call on 8250242229 (Puja) / Whats app on the same Number ***Though We Try and Answer The Calls Immediately, but Due to Heavy Call Flow The Below Numbers Might Be Busy At Times. In case you find the number busy, please WhatsApp your details to us in the below format: - 8250242229 (Puja) Name- Mobile number - Mail - Highest Qualification Highest qualification University Name Total work experience - Date of birth- Current Organization- Preferred Location Last CTC- Expected CTC: *Interested candidates can even refer their friends or relatives provided the criteria *FOR interview Call Now our HR Specialist: -----@ ** 8250242229 (Puja) (call or WhatsApp)

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Sr Analyst Qualifications: Bachelor of Pharmacy Years of Experience: 5 to 8 years 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.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.In this role, you will be expected to create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for? Ability to establish strong client relationship Ability to work well in a team Collaboration and interpersonal skills Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualifications Bachelor of Pharmacy

Project Role : Business Agility Practitioner Project Role Description : Professionals who provide business agility and technology innovation advisory services focused on organizational transformation in order to aid clients in outlearning and outperforming the competition. Must have skills : Computer System Validation (CSV) Good to have skills : Computer Vision Minimum 7.5 year(s) of experience is required Educational Qualification : Minimum 15 years of fulltime education Summary :As a Business Agility Practitioner, you will be responsible for providing advisory services focused on organizational transformation to aid clients in outlearning and outperforming the competition. Your typical day will involve utilizing your expertise in Computer System Validation (CSV) and Computer Vision to deliver impactful data-driven solutions. Roles & Responsibilities: Lead the development and implementation of Computer System Validation (CSV) strategies and methodologies to ensure compliance with regulatory requirements. Collaborate with cross-functional teams to identify and implement innovative solutions to improve business processes and drive organizational transformation. Provide advisory services to clients on technology innovation and business agility, leveraging your expertise in Computer System Validation (CSV) and Computer Vision. Develop and maintain strong relationships with clients, ensuring their needs are met and expectations are exceeded. Stay updated with the latest advancements in Computer System Validation (CSV) and Computer Vision, integrating innovative approaches for sustained competitive advantage. Professional & Technical Skills: Must To Have Skills:Expertise in Computer System Validation (CSV). Good To Have Skills:Knowledge of Computer Vision. Strong understanding of regulatory requirements and compliance related to Computer System Validation (CSV). Experience in providing advisory services to clients on technology innovation and business agility. Excellent communication and interpersonal skills to develop and maintain strong relationships with clients. Ability to stay updated with the latest advancements in Computer System Validation (CSV) and Computer Vision. Additional Information: The candidate should have a minimum of 7.5 years of experience in Computer System Validation (CSV). The ideal candidate will possess a strong educational background in computer science, engineering, or a related field, along with a proven track record of delivering impactful data-driven solutions. This position is based at our Bengaluru office. Qualifications Minimum 15 years of fulltime education

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years Language - Ability: Japanese - Elementary 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.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.In this role, you will be expected to create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for? Agility for quick learning Collaboration and interpersonal skills Commitment to quality Ability to perform under pressure Prioritization of workload 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 Qualifications Any Graduation

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: Bachelor of Pharmacy Years of Experience: 0 to 1 years Language - Ability: English - Advanced 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.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.In this role, you will be expected to create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for? In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualifications Bachelor of Pharmacy

Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Specialist Qualifications: Any Graduation Years of Experience: 8-10 Yrs 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 Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.You will be expected to develop and review complex edit checks, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. What are we looking for? You will be expected to develop and review complex edit checks, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualifications Any Graduation

Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Analyst Qualifications: BE,MCA,BTech Years of Experience: 3 - 5 Years Language - Ability: English - Advanced 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 Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.In this role, you will be expected to develop clinical trial reports using SAS/ J-review / Congnos / SQL / PLSQL as per the study requirement. What are we looking for? SAS Clinical SQL Databases Strong analytical skills Collaboration and interpersonal skills Written and verbal communication Ability to meet deadlines Adaptable and flexible Clinical Database Programming Experience in any clinical report development using PL/SQL or SAS JReview experience is added advantage. Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualifications BE,MCA,BTech

Skill required: Clinical Data Services - Clinical Data Management Designation: Clinical Data Svs Specialist Qualifications: Bachelor of Pharmacy Years of Experience: 7 to 11 years 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 Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. The role may require you to identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The role may also need expertise in managing clinical data management projects. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Roles and Responsibilities: Overall experience of 4+ years in Clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry preferred. o Participate in the lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. o Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders. o Facilitate interaction with end user on creating specifications and working with programmers or performing the programming activities for successful delivery. o Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, SAS, and JReview etc. preferred. o Good analytical and communication skills. Qualifications Bachelor of Pharmacy

Hi, We are hiring for Leading ITES Company for Medical Writer Profile. Role & Responsibilities: Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. Share project timelines amongst the study team for the development of document. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. Review statistical analysis plans and table/figure/listing, when required. Ensure uniformity and consistency in the scientific content of the regulatory documents Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies. Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. Plan and organize project and non-project meetings, as and when required To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Medical Writing Mumbai (Job Code # 56) b) For Position in Pune Search : Medical Writing Pune (Job Code # 57)

Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Specialist Qualifications: BE/BTech/MCA Years of Experience: 7 to 11 years 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 Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.In this role, you will be expected to develop clinical trial reports using SAS/ J-review / Congnos / SQL / PLSQL as per the study requirement. What are we looking for? SAS Clinical Oracle Procedural Language Extensions to SQL (PLSQL) Python (Programming Language) R Programming Clinical Database Programming Adaptable and flexible Ability to perform under pressure Problem-solving skills Agility for quick learning Ability to establish strong client relationship Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualifications BE,BTech,MCA

Job Responsibilities The Clinical Research Associate/Scientist will be responsible for: Scoping Help the team in rapid and accurate feasibility analysis of upcoming projects. Example projects are in the areas of Oncology, Reproductive health, metabolic disorders, neurodegenerative diseases etc often involving some genomics component to the study design, This involves engaging with investigators across the country, and getting reasonably accurate estimates of recruitment rates, often for difficult indications. 2. Planning and Setup Contribute in planning and setting up of new clinical studies including drafting/refining the study related documents and EC dossiers, Identify candidate sites and engage with PIs and site CRCs to assess feasibility for shortlisting sites, negotiate with sites to draft agreements for engagement, Put together necessary documentation for EC submissions and assist site teams as needed to ensure EC approvals are obtained in a timely manner Regular and prompt performing quality control (QC) checks on clinical data received. This involves reviewing the data for accuracy, consistency, and completeness, ensuring that all entries are correctly documented and any discrepancies or errors are identified and addressed in a timely manner. Collaborate with other team members to resolve any issues and ensure compliance with regulatory requirements. Plan the setup of other systems and processes for the smooth running of the trial including where needed setup of systems such as IVRS/IWRS, EDC for electronic CRFs, drafting of study documents, ISF etc. and take care of site initiation activities. Put together the necessary documentation for regulatory compliance submissions like DCGI/CTRI/HMSC etc., Manage vendors, contracts and sourcing and help in budgeting and meticulous planning of projects to ensure smooth implementation and execution of the studies. 3. Implementation & Execution Implement processes for efficient conduct of clinical projects/trials, Take care of necessary activities for training of site staffs and conducting the Site Initiation, Ensure that for each study, each site, each subject the data collection, data validation and monitoring is diligently done, Troubleshoot issues faced in clinical studies in a timely manner like recruitment of subjects using innovative ideas like putting in place systems to rigorously screen patients in OPDs, setting up referral networks with hospitals having substantial patient load, and working with investigators with different ideas for recruitment, Ensure adherence to GCP guidelines to carry out high quality clinical studies following good ethical practices, Ensure smooth handling and reporting of SAEs, payments of medical expenses, compensation, etc keeping record of the same for audit purpose, Track and update status of the studies, identify challenges, record issues with issue resolution matrix and discuss potential solutions in internal meetings, customer meetings etc., Manage the costs and timelines of implementation in line with the original proposal for the project Ensure that SOPs for the clinical studies are up-to-date and work with relevant team members for conducting the study in accordance with the SOP Ensure proper training of new team members, take care of documentation and records for sponsor audits, regulatory inspections and ensure that all the study records are diligently maintained for posterity Candidates Requirements Ph.D. degree in life sciences, fresher or with an experience of 1-2 years in oncology or clinical trials management Ability to successfully manage/work simultaneous trials and meet deadlines Clinical Data Management experience preferably as part of a CRO team in more than one therapeutic area would be an advantage Excellent understanding of clinical trials methodology, GCP (Good Clinical Practice), GDMP (Good clinical data management practice) and medical terminology Have comprehensive knowledge of clinical guidelines like NDCT (New Drugs and Clinical Trials) rules, ICMR guidelines, DCA (Drugs and Cosmetics Act) and procedures involved with relevant Govt regulatory bodies is desirable and will be an added advantage Good organizational skills as the job profile involves lot of documentation and recording of information through computerized processes of clinical trial management systems and electronic data capture High attention to details and a strong analytical mind set Demonstrates comprehensive knowledge of capturing and storing clinical information Excellent proficiency in English language Demonstrated experience of working in multicultural and multidisciplinary environments Dynamic team player with excellent communication and networking skills, flexible mindset and scientifically curious Willing to travel within city and outside as required (job demands 50% or travel and may require extended period of stay at a site location based on project need)

Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Analyst Qualifications: Master of Pharmacy,BSc Years of Experience: 3 - 5 Years Language - Ability: English - Expert What would you do? Experience in Clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry preferred. -Create reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation.-Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, SAS, and JReview etc. preferred.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.You will be expected to develop and review complex edit checks, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualifications Master of Pharmacy,BSc

Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Analyst Qualifications: Any Graduation,BSc Years of Experience: 3 to 5 years Language - Ability: English - Expert What would you do? Exposure to EDC platforms like Medidata RAVE EDC, Inform, Oracle Clinical, Veeva etc. preferred.-Extensive experience in database design, edit check programming, custom function programming and unit testing.-Experienced in various modules such as IVRS/RWS integration and Lab administration.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.You will be expected to develop and review complex edit checks, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualifications Any Graduation,BSc

Skill required: Com.Bkg- Commercial Real Estate - Real Estate Due Diligence Designation: Banking Advisory Senior Analyst Qualifications: BCom Years of Experience: 5 to 8 years What would you do? We help clients address quality and productivity issues, keep pace with customer expectations, navigate regulatory and operational pressures and ensure business sustainability by transforming their banking operations into an agile, resilient operating model.The Corporate banking /Wholesale banking team is responsible for helping clients and organizations processes trade finance transactions by providing superior service delivery to trade customers whilst safeguarding the bank from risks associated with this business.Identify and assess, prevent and mitigate and account to provide reasonable measures to adapt before executing an agreement in relation to the real estate and immovable property. Valuation of commercial real estate using software like Argus, extracting key information from lease agreements (including amendments) and rent rolls. What are we looking for? Team lead experience Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualifications BCom

Skill required: Clinical Data Operations - Customer Retention Program Implementation Designation: Associate Qualifications: Any Graduation Years of Experience: 1 - 3 Years What would you do? Intelligent Sales and Customer Operations provides an end-to-end, integrated, seamless solution across marketing, sales and service. The solutions enable clients to drive sustainable growth by enhancing their capabilities to deliver consistent, hyper-relevant experiences across the customer lifecycle. In the Inside Sales team you will provide support for lead/opportunity generation:conduct calls / send emails / connect via social media to generate leads, schedule "first meetings" for sales/pre-sales, conduct customer surveys, identify participants for events, and bring awareness of the product or offering on behalf of sales/marketing teams. The Customer Retention Program Implementation team is focused on driving loyalty, deliver customer and brand experiences, and address unmet customer needs that can impact customer perceived value. This team defines the value associated with such a program. What are we looking for? Ability to establish strong client relationship Ability to perform under pressure Adaptable and flexible Detail orientation Problem-solving skills 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 Qualifications Any Graduation