215 Meddra Jobs - Page 4

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Sr Analyst Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 5 to 8 years About Accenture 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. 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 worlds 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.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 Drug Safety senior associateDrug Safety senior associate 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 Qualification Bachelor of Pharmacy,Master of Pharmacy

We are seeking a Regulatory Affairs Executive with 1 to 3 years of experience in the pharmaceutical industry. The ideal candidate should have hands-on experience in compiling and reviewing ACTD and CTD dossiers for various regulatory submissions. Required Candidate profile B.Pharm & M.Pharm With Knowledge of Regulatory Affairs CTD ECTD DMF and Regulatory Guidelines are Eligible to Apply

Long Description 1 Responsible for lifecycle management of DSRM procedural documents in EDMS and non-procedural documents within due date which includes document creation, document revision, making document obsolete, making document effective, releasing document, sharepoint update and communication to relevant stakeholders 2 Responsible as SOP coordinator to perform roles as Author in edit step and QA authorisation in Release approval step 3 Responsible to perform role of Training Coordinator in Training step within EDMS as required 4 Oversight and management of compliance of DSRM training requirements and activities in LMS 4 Support and oversight of subsidiary Global PV training status as applicable 5 Oversight and management of Annual Basic PV compliance for India 6 Oversight on team's task completion, annexures, sharepoint updates and people management. 9 Creation of status presentations and other adhoc presentations as required 7 People Management Competencies Strategic Agility Innovation & Creativity Process Excellence Customer Centricity Collaboration Stakeholder Management Developing Talent Result Orientation Education- Life Science Post Graduate, MPharm, BPharm, Work Experience Experience in Pharmacovigilance operations, Quality Management System, Training, Use of Systems for SOPs and Training Management

We are looking for a seasoned Full Stack Developer with extensive experience in .NET technologies, RESTful APIs, and Windows Services. This role requires a sharp problem-solver who can work independently, translate business needs into technical execution, and deliver high-performance applications. Key Responsibilities: Develop scalable applications using .NET (C#) with REST APIs and Windows services Design and implement robust, maintainable back-end architecture Apply solid relational and dimensional database design principles Collaborate with cross-functional teams in an Agile/Scrum environment Break down business requirements into clear, actionable technical tasks Maintain code quality through reviews and unit testing Support DevOps processes for CI/CD if applicable Required Skills: 10+ years of experience in .NET/C# application development Strong understanding of REST API design and Windows services Proficiency in SQL Server or equivalent RDBMS systems Experience working with Agile methodologies Excellent communication and analytical skills Ability to work with minimal supervision Preferred Skills (Good to Have): Experience in pharmaceutical R&D, clinical systems, or healthcare IT Familiarity with medical coding standards (e.g., MedDRA, SNOMED, LOINC) Exposure to DevOps pipeline tools like Bitbucket, Jenkins, UrbanCode Deploy Understanding of regulated environments (e.g., GxP, CFR Part 11)

Hiring: Team Lead Clinical Trials | Work from Office | Pune Location: Kothrud, Pune Shift: Evening / Night Job Type: Full-time (Work from Office) Salary: As per experience and best in industry Job Description: We are hiring for the position of Team Lead Clinical Trials . The role involves end-to-end management of clinical trial operations with a strong focus on quality, compliance, and timelines. The ideal candidate will lead cross-functional teams, manage client communication, and ensure the smooth execution of projects. Key Responsibilities: Lead teams including operations managers, team leads, quality analysts, and support staff. Monitor workflow and performance to identify and resolve issues. Provide mentorship and support to team members to promote a high-performance culture. Manage client onboarding, workflow planning, and quality assurance. Ensure compliance with industry regulations and client expectations. Present operational updates to senior management. Act as the primary contact for client communication and relationship management. Required Qualifications: Bachelors degree in Pharmacy or Life Sciences. 5 to 8+ years of experience in clinical research (BPO/KPO environment). At least 2 to 4+ years of experience in a leadership or team management role. Strong verbal and written communication skills. Excellent organizational and multitasking abilities. Work Environment: This is a Work from Office role based in Pune. Benefits: Competitive salary package. Health insurance and paid time off. Professional growth and learning opportunities. Only Walk-In Interviews Interested Candidates Can Contact: Sanjana 9251688426

Experience: 5 - 7 yrs Work Mode: Work from Office Work Location: Bangalore LOOKING FOR IMMEDIATE JOINERS ONLY Job Description - Clinical Data Manager : OVERVIEW The Clinical Data Manager (CDM) is an independent role responsible for supporting the study team and developing comprehensive study documentation, designing database specifications, and overseeing validation, maintenance/data cleaning, and closeout activities for clinical trial databases. The CDM is recognized as the platform expert, leveraging cutting-edge tools and technologies to provide continuous data insights and ensure the timely delivery of high-quality results for Sponsors. The CDM has a strong foundation in clinical data management, combined with the agility to adapt as processes evolve towards the integration of clinical data science. KEY TASKS & RESPONSIBILITIES Define project specifications for Data Management services, including Protocol Conversion, Database Build, CRF Design and Data Review and Data Reconciliation tools. Understand external data collection, its integration into the clinical trial, and the management and reconciliation processes required to ensure its accuracy and relevance. Execute data cleaning strategies to accelerate the time to achieve subject data cleanliness and ensure high-quality, timely deliverables. Perform holistic data review and trending analysis via reporting and elluminate analytics to proactively identify issue, risks and develop mitigation strategies. Utilize artificial intelligence (AI) and machine learning (ML) for anomaly and outlier detection to enhance the efficiency and quality of trial data. Monitor and interpret key performance indicators (KPIs), metrics, dashboards, Clinical Trial Operational Analytics (CTOA), and reports to provide actionable recommendations to study lead(s)/project manager. Perform Query Management Define specifications and collaborate with technical team on configuration of centralized data management platform, elluminate Data Central for data cleaning strategy and oversight activities. Prepare and maintain data management documentation (e.g., DMP, CCGs, Help Text, DVS) and update throughout trial lifecycle. Review and ensure the quality control of team-developed deliverables, covering eCRFs, study documents, program/report specifications, outputs, and elluminate Data Central with analytics modules. Actively evaluate and contribute to enhance processes to increase efficiency and effectiveness. Collaborate and work as a team to ensure the deliverables are completed on time with high quality. Ensure compliance with industry quality standards, regulations, guidelines, and procedures. Other duties as assigned. CANDIDATE’S PROFILE: Education & Experience 5+ years’ experience in Clinical Data Management preferred. Bachelor’s degree in a health-related field or equivalent experience preferred. CCDM Certification preferred. Professional Skills Strong project management experience and project team leadership skills including work planning, work delegation and solving complex problems. Strong analytical and strategic thinking skills Detail oriented, ability to multitask with strong prioritization, planning and organization skills. Excellent collaborative skills Demonstrated command of the English language with proficiency in both verbal and written communication Technical Skills Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology Proficient with EDC and Clinical Data Management Systems Experience with Cloud SaaS platforms (preferred)Experience with data reporting tools such as Qlik, JReview, Spotfire preferred. Experience with RBQM methodology preferred. Exposure to CDISC guidelines and standards

We are looking for a highly motivated and detail-oriented individual to join our team as a Trainee Medical Reviewer in Bengaluru. The ideal candidate should have 0-1 years of experience. Roles and Responsibility Conduct thorough medical reviews of patient records and reports to ensure accuracy and compliance with regulatory requirements. Collaborate with cross-functional teams to identify and resolve issues related to medical review. Develop and maintain expertise in medical terminology, regulations, and guidelines. Provide high-quality support to the medical review team through data entry, documentation, and other administrative tasks. Participate in ongoing education and training to enhance knowledge and skills. Contribute to process improvements by identifying areas for enhancement and implementing changes. Job Strong understanding of medical terminology, regulations, and guidelines. Excellent analytical, communication, and problem-solving skills. Ability to work effectively in a team environment and build strong relationships with colleagues. Proficiency in Microsoft Office and other software applications. Strong attention to detail and ability to prioritize tasks. Ability to adapt to changing priorities and deadlines in a fast-paced environment. About Company Omega Healthcare Management Services Private Limited is a leading provider of healthcare management services, committed to delivering high-quality solutions to its clients. We offer a dynamic and supportive work environment, with opportunities for growth and development.

Skill required: Clinical Data Services - Clinical EDC Build Designation: Clinical Data Svs Sr Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 5 to 8 years Language - Ability: English(International) - Expert About Accenture 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. 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 worlds 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 clinical study databases by building electronic case report forms and program edit checks as per specifications. Support any updates or changes to the study database (e.g. Protocol amendments) through the change control process. What are we looking for Adaptable and flexibleAbility to perform under pressureProblem-solving skillsDetail orientationAbility to establish strong client relationship Roles and Responsibilities: Overall experience of 4+ years with 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. Medidata RAVE study builder certified preferred. Qualification BSc,Master of Pharmacy

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Bachelor in Physiotherapy/BSc. Nursing Years of Experience: 1 to 3 years About Accenture 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. 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 worlds 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.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 meet deadlinesAbility to work well in a teamAdaptable and flexible 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 Qualification Bachelor of Pharmacy,Bachelor in Physiotherapy,BSc. Nursing

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Analyst Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 3 to 5 years About Accenture 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. 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 worlds 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.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 Senior drug safety associateSenior drug safety associate Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Master of Pharmacy

Skill required: Com.Bkg- Commercial Real Estate - Real Estate Due Diligence Designation: Banking Advisory Associate Qualifications: BCom/MCom/Master of Business Administration Years of Experience: 1 to 3 years About Accenture 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. Visit us at www.accenture.com 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 Agility for quick learningAbility to work well in a teamAbility to perform under pressureCommitment to qualityDetail orientation 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 Qualification BCom,MCom,Master of Business Administration

Skill required: Com.Bkg- Commercial Real Estate - Real Estate Due Diligence Designation: Banking Advisory New Associate Qualifications: BCom/MCom/Master of Business Administration Years of Experience: 0 to 1 years About Accenture 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. Visit us at www.accenture.com 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 Ability to meet deadlinesAbility to perform under pressureAbility to work well in a teamAdaptable and flexibleCommitment to quality 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 Qualification BCom,MCom,Master of Business Administration

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Bachelor in Physiotherapy/BSc. Nursing Years of Experience: 1 to 3 years About Accenture 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. 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 worlds 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.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 flexibleAgility for quick learningAbility to work well in a team 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 Qualification Bachelor of Pharmacy,Bachelor in Physiotherapy,BSc. Nursing

Key Responsibilities: Responsible for the OT routine, equipment and patients. Reviews the doctors notes and the drug chart and acts as required Prepares nursing care plans and renders effective bedside nursing care Ensures medication safety and patient safety protocols are practiced. Manpower deployment prepares duty roster; assigns nursing and anesthesia technician as per requirements. Ensures efficient staffing, material, and equipment availability. Ensures nurses are competent and can handle tasks assigned to them. OT Scheduling: plans following day checks the booking register a day before surgery, notes and actions special requirements, co-ordinates with the surgeon & anesthetist; plans manpower, equipment and ensures OT is fully prepared for the specific surgery. Responsible for ensuring additional requirement of resource, blood procurement, equipment is made available Checks to ensure medications, consumables, instruments and equipments are available for the surgery. Ensures all equipment are fully functional; conducts random checks of surgical and laparoscopic instruments ensuring they are functional. Competently handles all equipment used in patient care; ensures team is competent in usage; ensures equipment is serviceable and readily available. Ensures documentation for all completed surgeries is updated and accurate. Maintains emergency stock of medications and consumables in OT. Co-ordinates with OT technician, biomedical team and housekeeping staff. Responsible for material management and cost control documentation, Indenting, receiving stock, storage and usage. Ensures no wastage and misuse. Responsible for narcotic management storage & documentation of usage. Aware of NABH & Nursing excellence standards and ensures implementation.

01 Managing the entire QA activities in the plant & Overall implementation of Quality Systems in all units. 02 Design, Develop and approve all Quality systems in all units. Monitoring, Documentation, and implementation of process development. 03 Responsible to handle regulatory audits USFDA ISO 9001-14001, EU,WHO, and their compliance in all units without any Major Non Compliance. Making sure that there is stability data to support retest or expiry dates and storage conditions on APIs and/or intermediates where appropriate; and Performing product quality reviews 04 Handling of statutory audits like Quality, EHS, KSPCB, -CDSCO, weight & scale inspector, Director of Factories & Boilers, Social audits etc and their compliance (Evaluated by No show cause notice and no complaints) 05 Making sure that critical deviations are investigated and resolved; 06 Approving all specifications and master production instructions, Test methods, Qualifications 07 Approving all procedures impacting the quality of intermediates or APIs 08 Making sure that quality related complaints are investigated and resolved 09 Adhering to QA budget. 10 To qualify company for various certifications. 11 Assuring QMS in all Units. Experience 15 - 20 Years Salary Not Disclosed Industry Pharma / R&D / Biotech Qualification B.Pharma, M.Sc Key Skills Quality Assurance Supervisor USFDA Compliance and Audits Pharmaceutical Quality Assurance

At Allstate, great things happen when our people work together to protect families and their belongings from lifes uncertainties. And for more than 90 years our innovative drive has kept us a step ahead of our customers evolving needs. From advocating for seat belts, air bags and graduated driving laws, to being an industry leader in pricing sophistication, telematics, and, more recently, device and identity protection. The Application Developer Lead Consultant provides code/design analysis and strategy, supports project planning, and develops code and designs for complex projects. They manage the review of code, design, and testing for lower band Application Developers and peers. They serve as a technical expert, coach and mentor for other application developer specialists and professionals. The Lead Consultant works closely with business partners to identify needs and design technology solutions toovercome process bottlenecks, reduce use of contingent claim resources, reduce compliance risks, or generally increase operational efficiency. They are often required to deliver tactical solutions that can be implemented within a few days. They are responsible for all phases of the application development cyclebeginning with requirements gathering, through release, and ultimately ongoing user support. Key Responsibilities Should have strong JAVA, spring boot, triage, TDD and test understanding. Assists with detailed project estimating and milestone planning. Reviews and validate accuracy of others estimates and works with project managers in continuous process improvement for estimating Develops code for complex to highly complex modules with high-level architecture, following documentation and development standards Ensures that design/code reviews are scheduled and executed; provide feedback and recommends solutions; ensures that design standards and documentation are followed and certifies that code meets quality standards; reviews and critiques code presented by team members. Critiques and evaluates detailed business, functional, and high-level technical requirements (including recovery, security and audit) Performs root cause analysis to prevent recurrence of problem and manages the resolution of complex problems Defines and manages process by which support and technical assistance is performed Leads and organizes testing reviews. Tracks and resolves complex defects and assists in planning efforts of complex functional tests in support of Quality Control (QC) Ensures project change management approach is followed and that enhancements are appropriately prioritized and developed, and delivered to Developers, Quality Control Analysts, and Environment Management personnel, and that all documentation is completed appropriately. Contributes to determining programming approach, tools, and techniques that best meet the business requirements. Promotes and defines development standards and high architectural standards. Education 4 year Bachelors Degree (Preferred) Experience 5 or more years of experience (Preferred) Supervisory Responsibilities This job does not have supervisory duties. Education & Experience (in lieu) In lieu of the above education requirements, an equivalent combination of education and experience may be considered. Primary Skills Application Development, Code Reviews, Process Improvements, Technical Consulting, Technical Shift Time Shift B (India) Recruiter Info Shriya Kumariskuow@allstate.com About Allstate Joining our team isnt just a job "” its an opportunity. One that takes your skills and pushes them to the next level. One that encourages you to challenge the status quo. And one where you can impact the future for the greater good. Youll do all this in a flexible environment that embraces connection and belonging. And with the recognition of several inclusivity and diversity awards, weve proven that Allstate empowers everyone to lead, drive change and give back where they work and live. Good Hands. Greater Together. The Allstate Corporation is one of the largest publicly held insurance providers in the United States. Ranked No. 84 in the 2023 Fortune 500 list of the largest United States corporations by total revenue, The Allstate Corporation owns and operates 18 companies in the United States, Canada, Northern Ireland, and India. Allstate India Private Limited, also known as Allstate India, is a subsidiary of The Allstate Corporation. The India talent center was set up in 2012 and operates under the corporations Good Hands promise. As it innovates operations and technology, Allstate India has evolved beyond its technology functions to be the critical strategic business services arm of the corporation. With offices in Bengaluru and Pune, the company offers expertise to the parent organizations business areas including technology and innovation, accounting and imaging services, policy administration, transformation solution design and support services, transformation of property liability service design, global operations and integration, and training and transition. Learn more about Allstate India here.

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: Bachelor of Pharmacy Years of Experience: 0 to 1 years About Accenture 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. 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 worlds 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.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 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. Basic knowledge in Medical TerminologyBasic knowledge about Pharmaceuticals & Clinical Research 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 Qualification Bachelor of Pharmacy

: 1. Monitoring and analysis of cyber security events using Microsoft Sentinel SIEM. 2. Monitor internal and external threats, examine logs, events, and alerts generated by multiple platforms for anomalous activity. 3. Development and execution of SOC and standard operating procedures (SOP). 4. Triage security events and incidents, detect anomalies, and report/direct remediation actions. 5. Timely escalate security incidents whenever SLA's are not met. 6. Assist in incident detection and resolving incidents by following all phases of incident management lifecycle. 7. Integrate and collaborate threat information to improve incident detection capabilities. 8. Should be capable of report generation from security solutions and preparation of report for management or leadership review. 9. Collect evidence of security incidents, and other error conditions that may constitute a breach in security or a degradation of integrity or confidentiality of systems and data. Ability to coordinate and work with stakeholders to track security incidents till closure.

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years About Accenture 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. 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 worlds 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.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 Drug Safety AssociateDrug Safety Associate 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 Qualification Bachelor of Pharmacy,Master of Pharmacy

Skill required: Clinical Data Services - Clinical Data Management Designation: Clinical Data Svs Associate Qualifications: Bachelor of Pharmacy Years of Experience: 1 to 3 years About Accenture 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. 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 worlds 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.A critical phase in clinical research that assures collection, integration and availability of data at appropriate quality and cost. It also supports the conduct, management and analysis of studies across the spectrum of clinical research as defined by the National Institutes of Health (NIH). What are we looking for Ability to establish strong client relationship Roles and Responsibilities: Update BOT query sheet as and when requested by the TDM.Ensure completeness and validity of clinical as well as external data.Generate missing page report and track missing pages, as required.Track discrepancy and query status of assigned studies/Investigative sites as applicable.Review data from first data received to last data received and for selected tasks supporting the interim analysis/final database lock by operating in a continuous cleaning process.Perform DD pass activities as needed.Perform review for SDTM Data sets (SITS), P21 and other applicable reports.Share the weekly study metrics with TDM.Act as back up for TDM and lead study related meetings/document MOM and perform task allocation applicable for Data Manager, as needed.Upload standard reports/manual listings (DQPM listings) to central client location as guided by Lead Data Manager or client counterparts.Maintain an issue log to track and resolve discrepancies. Ensure issue clarification/follow-up until closure per the Issue Escalation Process/guidelines, as applicable.Interact with the TDM/Lead regarding data quality issues and assist them in tracking, monitoring the progress of data review activities.Accountable for high quality and on time delivery for assigned deliverables.Achieve the applicable SLA/KPI metrics. Qualification Bachelor of Pharmacy

Employment Type: Contract Top 3 skills which is mandatory Aris, BPM, Functional and Technical Setup and ongoing maintenance and oversight of the ARIS architecture & libraries Design and develop the reporting capabilities on ARIS to meet the requirements of the Group Configuration of ARIS system for the Process Mapping team ensuring it remains fit for purpose for the Group`s requirements. Develop detailed understanding of ARIS standard setup and functionality Responsibility for the day-to-day administration of ARIS including user set up, licence allocation, recertification, etc. Ensure ARIS system procedures remain accurate and up-to-date with Group`s policies and standards. Repository Clean up Management of new library content scripts vs manual maintenance Integrations Vs schedule reports to ABACUS, Radar and HR Process Governance for change and release management ARIS reporting

Employment Type: Contract Setup and ongoing maintenance and oversight of the ARIS architecture & libraries Design and develop the reporting capabilities on ARIS to meet the requirements of the Group Configuration of ARIS system for the Process Mapping team ensuring it remains fit for purpose for the Group`s requirements. Develop detailed understanding of ARIS standard setup and functionality Responsibility for the day-to-day administration of ARIS including user set up, licence allocation, recertification, etc. Ensure ARIS system procedures remain accurate and up-to-date with Group`s policies and standards. Repository Clean up Management of new library content scripts vs manual maintenance Integrations Vs schedule reports to ABACUS, Radar and HR Process Governance for change and release management ARIS reporting

Skills: Excellent writing and editing skills with the ability to create clear, concise, and engaging contentStrong knowledge of medical terminology, scientific concepts. #Exp5+ Years #LocationHydrabad (Hybrid) #clientNTTDATA. #Job description Good Experience in Medical Writer.

Role Purpose The purpose of the role is to provide effective technical support to the process and actively resolve client issues directly or through timely escalation to meet process SLAs. Do Support process by managing transactions as per required quality standards Fielding all incoming help requests from clients via telephone and/or emails in a courteous manner Document all pertinent end user identification information, including name, department, contact information and nature of problem or issue Update own availability in the RAVE system to ensure productivity of the process Record, track, and document all queries received, problem-solving steps taken and total successful and unsuccessful resolutions Follow standard processes and procedures to resolve all client queries Resolve client queries as per the SLAs defined in the contract Access and maintain internal knowledge bases, resources and frequently asked questions to aid in and provide effective problem resolution to clients Identify and learn appropriate product details to facilitate better client interaction and troubleshooting Document and analyze call logs to spot most occurring trends to prevent future problems Maintain and update self-help documents for customers to speed up resolution time Identify red flags and escalate serious client issues to Team leader in cases of untimely resolution Ensure all product information and disclosures are given to clients before and after the call/email requests Avoids legal challenges by complying with service agreements Deliver excellent customer service through effective diagnosis and troubleshooting of client queries Provide product support and resolution to clients by performing a question diagnosis while guiding users through step-by-step solutions Assist clients with navigating around product menus and facilitate better understanding of product features Troubleshoot all client queries in a user-friendly, courteous and professional manner Maintain logs and records of all customer queries as per the standard procedures and guidelines Accurately process and record all incoming call and email using the designated tracking software Offer alternative solutions to clients (where appropriate) with the objective of retaining customers and clients business Organize ideas and effectively communicate oral messages appropriate to listeners and situations Follow up and make scheduled call backs to customers to record feedback and ensure compliance to contract /SLAs Build capability to ensure operational excellence and maintain superior customer service levels of the existing account/client Undertake product trainings to stay current with product features, changes and updates Enroll in product specific and any other trainings per client requirements/recommendations Partner with team leaders to brainstorm and identify training themes and learning issues to better serve the client Update job knowledge by participating in self learning opportunities and maintaining personal networks Deliver NoPerformance ParameterMeasure1ProcessNo. of cases resolved per day, compliance to process and quality standards, meeting process level SLAs, Pulse score, Customer feedback2Self- ManagementProductivity, efficiency, absenteeism, Training Hours, No of technical training completedMandatory Skills: Pharmacovigilance & Drug Safety(Pharma). Experience1-3 Years.

Role & responsibilities Responsible for daily case processing of adverse event cases (clinical trial and/or post marketed), including coding using MedDRA, determining seriousness and expectedness at the event and case level. Perform case follow up activities such as identification of information to be collected during follow-up. Creating and reviewing case narratives. Providing client notifications as required for case management. Case downloading from regulatory authority websites Submission to applicable regulatory authorities within stipulated timelines Supporting and contributing to the development of training materials and training delivery. Highlight areas of concern/discrepancies to the Principal PV Specialist, Case Processing and/or Manager, Case Processing when related to ICSRs. Acquire and maintain an up-to-date knowledge of global safety regulations for medicines. Peer reviews of cases for quality, consistency, and accuracy as needed. Other duties as assigned Preferred candidate profile Strong verbal, written and interpersonal communication skills. High level of accuracy and attention to detail. Excellent organization and prioritization skills; able to multitask. Basic knowledge of Pharmacovigilance. Interested applicants can also apply directly with updated CV to hr@qpsbioserve.com