195 Case Processing Jobs - Page 6

First link of management between the executors ie field staff and management. An effective communicator with exceptional relationship management skills with ability to relate to people at all levels of business and management. Delivery of business AOP objectives for the assigned geography. PRINCIPAL ACCOUNTABILITIES (Accountabilities associated with the job) Achieving business numbers with the assigned line of channels (Basis location and market potential). People Management (Off roll) - Hiring, Retention Productivity. Sales Governance through compliance of systems and processes. Responsible for tracking, managing controlling PDD requirement compliance Reduction in customer complaints cancellation by ensuring that no miss-selling is being done. Understanding of CRM - Salesforce.com. Effectively engage with Credit, Operations, Risk within 2W/3W teams. To ensure TAT is maintained for case processing. 4. MAJOR CHALLENGES (Challenges faced on an on-going basis in carrying out the job) Training of self and their team below. Hiring right candidate. Smooth onboarding to help settle the employee we'll in BFL. Smooth onboarding of New Dealer/Partner with BFL Retention of Off-roll staff 5. DECISIONS (Key decisions taken by job holder at his/her end) Hiring of Off roll staff Approvals by coordinating with internal stake holders eg. Clearing cases Lead allocation Field activity planning and closure 6. INTERACTIONS (Key working relationships a job holder needs to have INSIDE and OUTSIDE the company to accomplish the job) Internal Clients Roles you need to interact with inside the organization to enable success in your day to day work Connect with various internal department ie product, credit, Ops, RCS compliance to process the file. Connect with HR department for hiring retention External Clients Roles you need to interact with outside the organization to enable success in your day to day work Engaging with customer. Mapping of market competition. 7. DIMENSIONS (Key numerical data which will reflect the scope and scale of activities concerning this job) Financial Dimensions (These should be quantifiable numerical amounts) From 45 to 70 Cases MOM (depending upon location and market potential) Other Dimensions (Significant volume dimensions associated with the job) Total Team Size: 9 Number of Direct Reports: 5 to 9 Number of Indirect Reports: NA Number of Outsourced employees: 5 to 9 Number of locations: 1 to 4 Number of products: 1 ie Two wheeler Loan Required Qualifications and Experience SKILLS AND KNOWLEDGE (Minimum acceptable proficiency for this job which best indicates the education and/or experience requirements of this job and not the incumbent) Educational Qualifications Qualifications - Graduate / Post Graduate Good command in excel is essential. Work Experience - 1 to 3 years of relevant experience in managing team Result oriented - Go getter attitude is must Should have collaborative work style to engage with peers colleagues across the company. Excellent Team management Interpersonal Skills. Excellent command over communication skills. Highly ambitious self-motivated

First link of management between the executors ie field staff and management. An effective communicator with exceptional relationship management skills with ability to relate to people at all levels of business and management. Delivery of business AOP objectives for the assigned geography. PRINCIPAL ACCOUNTABILITIES (Accountabilities associated with the job) Achieving business numbers with the assigned line of channels (Basis location and market potential). People Management (Off roll) - Hiring, Retention Productivity. Sales Governance through compliance of systems and processes. Responsible for tracking, managing controlling PDD requirement compliance Reduction in customer complaints cancellation by ensuring that no miss-selling is being done. Understanding of CRM - Salesforce.com. Effectively engage with Credit, Operations, Risk within 2W/3W teams. To ensure TAT is maintained for case processing. 4. MAJOR CHALLENGES (Challenges faced on an on-going basis in carrying out the job) Training of self and their team below. Hiring right candidate. Smooth onboarding to help settle the employee we'll in BFL. Smooth onboarding of New Dealer/Partner with BFL Retention of Off-roll staff 5. DECISIONS (Key decisions taken by job holder at his/her end) Hiring of Off roll staff Approvals by coordinating with internal stake holders eg. Clearing cases Lead allocation Field activity planning and closure 6. INTERACTIONS (Key working relationships a job holder needs to have INSIDE and OUTSIDE the company to accomplish the job) Internal Clients Roles you need to interact with inside the organization to enable success in your day to day work Connect with various internal department ie product, credit, Ops, RCS compliance to process the file. Connect with HR department for hiring retention External Clients Roles you need to interact with outside the organization to enable success in your day to day work Engaging with customer. Mapping of market competition. 7. DIMENSIONS (Key numerical data which will reflect the scope and scale of activities concerning this job) Financial Dimensions (These should be quantifiable numerical amounts) From 45 to 70 Cases MOM (depending upon location and market potential) Other Dimensions (Significant volume dimensions associated with the job) Total Team Size: 9 Number of Direct Reports: 5 to 9 Number of Indirect Reports: NA Number of Outsourced employees: 5 to 9 Number of locations: 1 to 4 Number of products: 1 ie Two wheeler Loan Required Qualifications and Experience SKILLS AND KNOWLEDGE (Minimum acceptable proficiency for this job which best indicates the education and/or experience requirements of this job and not the incumbent) Educational Qualifications Qualifications - Graduate / Post Graduate Good command in excel is essential. Work Experience - 1 to 3 years of relevant experience in managing team Result oriented - Go getter attitude is must Should have collaborative work style to engage with peers colleagues across the company. Excellent Team management Interpersonal Skills. Excellent command over communication skills. Highly ambitious self-motivated

Job Summary Join our dynamic team as a Pharmacovigilance Specialist where you will leverage Generative AI to enhance drug safety processes. This hybrid role offers the opportunity to work on cutting-edge projects in Research and Development and PV Case Processing ensuring the well-being of patients worldwide. With a focus on innovation you will contribute to the companys mission of improving healthcare outcomes. Responsibilities Utilize Generative AI tools to analyze and interpret pharmacovigilance data ensuring accurate and timely reporting. Collaborate with cross-functional teams to develop strategies for effective PV case processing and management. Conduct thorough research and development activities to improve drug safety protocols and procedures. Implement innovative solutions to streamline pharmacovigilance processes and enhance efficiency. Monitor and evaluate the impact of AI-driven methodologies on drug safety outcomes. Provide insights and recommendations based on data analysis to support decision-making in pharmacovigilance. Ensure compliance with regulatory requirements and industry standards in all pharmacovigilance activities. Participate in the development and maintenance of pharmacovigilance databases and systems. Support the preparation and submission of safety reports to regulatory authorities. Assist in the identification and assessment of potential safety signals and trends. Contribute to the continuous improvement of pharmacovigilance practices through research and innovation. Engage in knowledge sharing and training sessions to enhance team capabilities in AI and pharmacovigilance. Foster a collaborative environment that encourages creativity and problem-solving in drug safety initiatives. Qualifications Demonstrate proficiency in Generative AI and its application in pharmacovigilance processes. Possess a strong understanding of research and development methodologies in drug safety. Exhibit experience in PV case processing and management. Show familiarity with regulatory requirements and industry standards in pharmacovigilance. Display excellent analytical and problem-solving skills. Have the ability to work effectively in a hybrid work model. Demonstrate strong communication and collaboration skills. Certifications Required Certification in Generative AI applications in healthcare or pharmacovigilance.

Job Summary The Process Specialist-CDM/PV role involves managing and optimizing processes within Pharma Research & Development. The candidate will contribute to enhancing safety operations and pharmacovigilance case processing. With a hybrid work model and rotational shifts the role demands adaptability and technical expertise. The position does not require travel. Responsibilities Oversee the management and optimization of processes within Pharma Research & Development to ensure efficiency and compliance. Provide support in pharmacovigilance case processing ensuring accurate and timely documentation of safety data. Collaborate with cross-functional teams to enhance safety operations and improve overall process effectiveness. Analyze data and generate reports to support decision-making and strategic planning in pharmacovigilance activities. Implement best practices and innovative solutions to streamline processes and improve productivity. Ensure adherence to regulatory requirements and industry standards in all aspects of pharmacovigilance and safety operations. Facilitate communication and coordination between different departments to achieve seamless workflow and process integration. Monitor and evaluate process performance identifying areas for improvement and implementing corrective actions. Assist in the development and maintenance of standard operating procedures to ensure consistency and quality in process execution. Support training and development initiatives to enhance team capabilities and knowledge in pharmacovigilance and safety operations. Utilize technical skills to troubleshoot and resolve process-related issues minimizing disruptions and ensuring smooth operations. Contribute to the continuous improvement of processes by providing insights and recommendations based on data analysis. Engage in rotational shifts to provide consistent support and coverage across different time zones. Qualifications Possess a strong background in Pharma Research & Development with experience in pharmacovigilance case processing. Demonstrate proficiency in safety operations and regulatory compliance within the pharmaceutical industry. Exhibit excellent analytical skills and the ability to interpret complex data sets for informed decision-making. Show adaptability to work in a hybrid model and manage rotational shifts effectively. Have a keen eye for detail and a commitment to maintaining high standards of quality and accuracy. Display effective communication skills to collaborate with cross-functional teams and stakeholders. Be proactive in identifying process improvements and implementing innovative solutions. Hold a relevant degree in pharmaceutical sciences or a related field. Have a minimum of 2 years and a maximum of 4 years of experience in the pharmaceutical industry. Experience in PV Case Processing and Safety Ops is considered a valuable asset. Demonstrate the ability to work independently and as part of a team to achieve organizational goals. Show commitment to continuous learning and professional development in pharmacovigilance and safety operations. Be familiar with industry-standard software and tools used in pharmacovigilance and process management.

Aster Medcity is looking for Registered Nurse to join our dynamic team and embark on a rewarding career journey. Supervise nursing staff in a hospital or clinical settings. Oversee patient care, make management and budgetary decisions, set work schedules, coordinate meetings, and make personnel decisions. Recruit and train nurses and other health care professionals and maintain a facilitys records. Work with staff to apply emerging nursing theories to care delivery. Also implement state and federal regulatory guidelines for patient safety and educate staff about any changes in the laws and how they impact care delivery.

Career Category Information Systems Job Description Join Amgen s Mission of Serving Patients At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. What you will do Let s do this. Let s change the world. In this vital role you will maximises domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the software development teams. This role involves working closely with business collaborators, Data engineers, AI/ML engineers to ensure that the technical requirements for upcoming development are thoroughly elaborated. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will collaborate with the Product Owner and developers to maintain an efficient and consistent process, ensuring quality deliverables from the team. Roles & Responsibilities: Collaborate with System Architects and Product owners to manage business analysis activities, ensuring alignment with engineering and product goals. Monitor, solve, and resolve issues related to case intake and case processing across multiple systems. Work with Product Owners and customers to define scope and value for new developments. Stay focused on software development to ensure it meets requirements, providing proactive feedback to collaborators. Design, implement, and maintain automated CI/CD pipelines for seamless software integration and deployment. Collaborate with developers to enhance application reliability and scalability. Troubleshoot deployment and infrastructure issues, ensuring high availability. Collaborate with business subject matter experts, testing teams and Product Management to prioritize release scopes and groom the Product backlog. Maintain and ensure the quality of documented user stories/requirements in tools like Jira. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree and 1 to 3 years of Life Science / Biotechnology / Pharmacology / Information Systems experience OR Bachelor s degree and 3 to 5 years of Life Science / Biotechnology / Pharmacology / Information Systems experience OR Diploma and 7 to 9 years of Life Science / Biotechnology / Pharmacology / Information Systems experience Preferred Qualifications: Functional Skills: Must-Have Experienced in MuleSoft, Java, J2ee & database programming. Demonstrated expertise in monitoring, troubleshooting, and resolving data and system issues. Proficiency in CI/CD tools (Jenkins, GitLab CI/CD, GitHub Actions, or Azure DevOps). Hands-on experience with the ITIL framework and methodologies like (Scrum). Knowledge of SDLC process, including requirements, design, testing, data analysis, change control Functional Skills: Good to Have Experience in managing GxP systems and implementing GxP projects. Knowledge of Artificial Intelligence (AI), Robotic Process Automation (RPA), Machine Learning (ML), Natural Language Processing (NLP) and Natural Language Generation (NLG) automation technologies with building business requirements. Knowledge of cloud technologies such as AWS. Excellent communication skills and the ability to communicate with Product Managers and business collaborators to define scope and value for new developments. Experience of DevOps, Continuous Integration, and Continuous Delivery methodology, and CRM systems Soft Skills: Excellent analytical and troubleshooting skills Able to work under minimal supervision Strong verbal and written communication skills High degree of initiative and self-motivation Team-oriented, with a focus on achieving team goals Ability to manage multiple priorities successfully Ability to deal with ambiguity and think on their feet Shift Information: This position may require you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers. amgen. com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. .

Career Category Information Systems Job Description Join Amgen s Mission of Serving Patients At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. What you will do Let s do this. Let s change the world. In this vital role you will join a collaborative team implementing and supporting the Integrated Case Management Systems on existing & future technologies. In this role, you will wear several hats including requirement gathering, implementation and analyze and resolve issues with case intake and data transfer across integrated systems. Collaborating closely with various teams, you will develop insights and implement solutions to improve system performance, ensuring reliable and efficient processing of data. Roles & Responsibilities: Develop and implement business process improvements to enhance efficiency and effectiveness. Monitor, solve, and resolve issues related to case intake and case processing across multiple systems. Work closely with internal teams, external vendors, and business partners to address dependencies and resolve bottlenecks for critical issues. Collaborate on the development of test plans and scenarios to ensure robust validation of system updates, patches and new features. Perform regression testing to verify the changes do not negatively impact existing system functionality. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree and 1 to 3 years of Life Science / Biotechnology / Pharmacology / Information Systems experience OR Bachelor s degree and 3 to 5 years of Life Science / Biotechnology / Pharmacology / Information Systems experience OR Diploma and 7 to 9 years of Life Science / Biotechnology / Pharmacology / Information Systems experience Preferred Qualifications: Functional Skills: Must-Haves Experience in writing user requirements and acceptance criteria in agile project management systems such as JIRA Good communication skills and the ability to communicate with Product Managers and business collaborators to define scope and value for new developments Hands-on experience with the ITIL framework and methodologies like (Scrum). Knowledge of SDLC process, including requirements, design, testing, data analysis, change control Functional Skills: Good to Have Hands on experience in HP ALM, JIRA, Visio, document management systems (e. g. Veeva) and Service Now Experience in management of requirements specifications document, requirements traceability matrix Experience of DevOps, Continuous Integration, and Continuous Delivery methodology, and CRM systems Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills. Ability to work effectively with global, virtual teams. High degree of initiative and self-motivation. Team-oriented, with a focus on achieving team goals. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers. amgen. com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. .

About the Role Join our fast-growing litigation practice and build your courtroom skills from day one. As a Junior Associate you will assist senior lawyers in drafting, research and daily court work while developing a solid foundation in civil and commercial litigation. Key Responsibilities Court work: Appear before District Courts, Commercial Courts and other forums in Gurugram/NCR; assist with filing, listing and hearing formalities. Drafting: Prepare and vet plaints, written statements, applications, petitions, replies, affidavits, notices, contracts and legal opinions. Research & Briefing: Compile case law, statutes and precedents; draft research notes and case briefs for Associates and Senior Associates. Client & Stakeholder Coordination: Interface with clients, court staff, counsel and authorities to track deadlines and ensure smooth matter management. File & Timeline Management: Maintain digital and physical records of pleadings, evidence and hearing dates; monitor limitation periods and compliance schedules. Desired Profile LL.B. from a recognized university. Enrolled with a State Bar Council and entitled to practise in India. Impeccable written and spoken English; clear, concise drafting style. Working knowledge of CPC, BNS, BNSS, CrPC, IPC, Evidence Act and key substantive laws. Ability to multitask in a high-volume, time-sensitive environment. Prior internships or exposure to litigation will be a plus. What We Offer Hands-on courtroom exposure and mentoring by experienced litigators. Structured training in drafting, procedural strategy and client management. Competitive monetary incentives with performance-linked increments. Supportive, collegial work culture focused on professional growth. To Apply Email your CV and a brief cover letter (maximum 300 words) to support@lawtimesindia.com with the subject line Application Junior Associate (Litigation)” . Short-listed candidates will be invited for a drafting assignment and interview. Come build your litigation career with us—where every appearance counts.

Medical Review Scientist What you will do Let’s do this. Let’s change the world. In this vital role you will provide medical review of individual case safety reports (ICSRs) in support of safety surveillance for Amgen products To support global individual case safety reports regulatory reporting compliance To assure medical validity of ICSRs and provide input to the activities of Medical Safety Review Team (MSRT) To implement the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports To act as a significant point of contact for Case Management on medical content of ICSRs Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. Produce medically accurate ICSRs reports Support MSRT product lead if assigned Execute ICSR case escalation as appropriate Execute appropriate case follow up per SOPs Support medical coding conventions, and systematic process improvements for ICSR medical review Conduct reportability assessment for medical device associated events and /or product complaint associated events, and review for potential product problems. Support MSRT Product Lead activities for the list of expected terms in the auto label tool Support Quality Assurance of ICSR medical review (if applicable) Support training to vendor staff (if applicable) on ICSR medical review Mentor junior medical reviewers. Participate in Safety Assessment Team (SAT) (if applicable) Provide input on teams for interdepartmental and cross-functional initiatives including process improvement, standards development, Standard Operating Procedures (SOP) creation, and metrics with regards to medical review Perform other duties related to the position as necessary as defined in SOPs or as requested by his/her supervisor Inspection Readiness: Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: MD/DO or international equivalent AND 3 years of related drug safety experience Knowledge of Amgen Medical review and case management SOPs and regulatory requirements for pharmacovigilance Clinical knowledge of therapeutic area patient populations and drug class Proficiency in technical safety systems including the Amgen Safety database and medical coding Knowledge of safety data capture in clinical trials and in the post marketing environments Knowledge of clinical trials and drug development Knowledge of Amgen products and patient population (preferred) Preferred Qualifications: MD/DO or international equivalent AND 4 years relevant work What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Case Management QA Vendor Associate What you will do Support interactions with business partners (license partners) and vendors for all case intake and processing activities. Vendor oversight of all case intake and processing activities and case quality including analysis and reporting of trends in quality measures. Ensure vendor compliance with approved processes and training requirements. Submission of all individual case safety reports to FDA/EMA, business partners (license partners), and vendors. Act as US/EU local safety office and FDA/EMA point of contact for safety reporting. Provide audit & external inspection support. Assist in assuring quality of Individual Case Safety Report (ICSR) processing globally for clinical trial and post-market cases processed by vendors Ensure Vendors deliver high quality cases through metric management meet all worldwide regulatory authority requirements Provide vendors with resources and training to perform their role Analysis and communication of case Quality Control results Responsible for escalation of case related issues from vendor(s) Providing audit/inspection support for case management related activities, including liaising with vendors to provide support as applicable Undertaking activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the PV System Master File and maintain a state of inspection readiness May assist with Periodic Aggregate Safety Reports (PASR) processes and associated metrics throughout the product lifecycle as applicable Other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by their supervisor Work within the Quality Management System framework including all applicable training and controlled documentation governing Pharmacovigilance processes Ensure vendor case processing timelines for AE intake, triage and submission are met Perform retrospective quality assurance of vendor processed cases Day-to-day vendor management issues Interact with other local safety offices as applicable Support on-boarding and off-boarding of vendor staff Attend management meetings with vendors Support analysis of QC trends Support generating, communicating, and archiving of reports of QC findings Support audits of CAPAs and other actions/recommendations for ICSR quality related measures Perform case review as required Generate and distribute performance metrics (retro QA / Case correction) Support analysis of QC trends including actions/recommendations What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Bachelor’s degree and 3 years of directly related experience (OR) Associate’s degree and 5 years of directly related experience (OR) High school diploma / GED and 7 years of directly related experience (AND) Previous experience directly managing teams, projects, programs or directing the allocation of resources Preferred Skills: Understanding of global regulatory requirements for pharmacovigilance Proficiency in safety case processing Expertise in all aspects of case intake and processing in multiple global safety databases Experience in supporting inspections or internal audits Communication skills and attention to detail Microsoft SuiteWord, Excel, PowerPoint, Project, Outlook What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Case Management QA Vendor Sr Associate What you will do Support interactions with business partners (license partners) and vendors for all case intake and processing activities. Vendor oversight of all case intake and processing activities and case quality including analysis and reporting of trends in quality measures. Ensure vendor compliance with approved processes and training requirements. Submission of all individual case safety reports to FDA/EMA, business partners (license partners), and vendors. Act as US/EU local safety office and FDA/EMA point of contact for safety reporting. Provide audit & external inspection support. Assist in assuring quality of Individual Case Safety Report (ICSR) processing globally for clinical trial and post-market cases processed by vendors Ensure Vendors deliver high quality cases through metric management meet all worldwide regulatory authority requirements Provide vendors with resources and training to perform their role Analysis and communication of case Quality Control results Responsible for escalation of case related issues from vendor(s) Providing audit/inspection support for case management related activities, including liaising with vendors to provide support as applicable Undertaking activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the PV System Master File and maintain a state of inspection readiness May assist with Periodic Aggregate Safety Reports (PASR) processes and associated metrics throughout the product lifecycle as applicable Other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by their supervisor Work within the Quality Management System framework including all applicable training and controlled documentation governing Pharmacovigilance processes Ensure vendor case processing timelines for AE intake, triage and submission are met Perform retrospective quality assurance of vendor processed cases Day-to-day vendor management issues Interact with other local safety offices as applicable Support on-boarding and off-boarding of vendor staff Attend management meetings with vendors Support analysis of QC trends Support generating, communicating, and archiving of reports of QC findings Support audits of CAPAs and other actions/recommendations for ICSR quality related measures Perform case review as required Generate and distribute performance metrics (retro QA / Case correction) Support analysis of QC trends including actions/recommendations What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Master’s degree and 3 years of directly related experience (OR) Bachelor’s degree and 5 years of directly related experience (OR) Associate’s degree and 10 years of directly related experience (OR) High school diploma / GED and 12 years of directly related experience (AND) Previous experience directly managing teams, projects, programs or directing the allocation of resources Preferred Skills: Understanding of global regulatory requirements for pharmacovigilance Proficiency in safety case processing Expertise in all aspects of case intake and processing in multiple global safety databases Experience in supporting inspections or internal audits Communication skills and attention to detail Microsoft SuiteWord, Excel, PowerPoint, Project, Outlook What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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 Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the 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

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 Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the 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: 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 Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the 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

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Specialist Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 7 to 11 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the 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 Looking for a MBBS graduateLooking for a MBBS graduate 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 Qualification Bachelor of Pharmacy,Master of Pharmacy

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 Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the 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: Clinical Data Services - Clinical Data Management Designation: Clinical Data Svs New Associate Qualifications: MSc/Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 0 to 1 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the 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 relationshipAbility to handle disputesAbility to manage multiple stakeholdersAbility to meet deadlinesAbility to perform under pressure 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 MSc,Bachelor of Pharmacy,Master of Pharmacy

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 Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do 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 teamAdaptable and flexibleAbility to perform under pressureCommitment 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: 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 Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do 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

Deva Institute of Healthcare and Research Pvt Ltd is looking for Clinical Research Coordinator to join our dynamic team and embark on a rewarding career journey. Coordinate and manage clinical trials from initiation to completion, ensuring compliance with regulatory guidelines and study protocols Recruit, screen, and enroll study participants while maintaining accurate documentation and records Monitor patient safety, manage informed consent, and schedule follow-ups Communicate with investigators, sponsors, and regulatory authorities to ensure timely updates and reporting Maintain study supplies, track data collection, and support data analysis, ensuring high-quality and ethical research practices throughout the study

Job Description Job Title: Local Case Intake Advisor - Global Business Services Fluent in Arabic / French Work mode- Hybrid Introduction to role: Are you ready to make a difference in the world of patient safety? As a Local Case Intake Advisor, you'll be at the forefront of managing the intake, processing, and reporting of individual case safety reports (ICSRs) at the local level. This pivotal role supports specific local Marketing Companies, ensuring compliance with AstraZeneca and national regulatory requirements. You'll be the primary liaison between these Marketing Companies and GBS-PS, working under the guidance of Case Intake Team Managers. Your mission? Deliver routine activities independently, resolve moderate scope and complexity problems, and uphold company values and compliance standards. Accountabilities: Dive into the world of pharmacovigilance by supporting the processing and handling of ICSRs, including adverse event reporting from clinical and post-marketed sources for AstraZeneca products. Engage with Health Authorities for ICSR-related queries and contribute to the operational implementation of the Quality Management System. You'll manage procedural document management, AE/PV training requirements, quality incident reporting, and audit readiness. Collaborate on PV aspects related to Organised Data Collection Programmes, Digital and Social Media activities, and partnerships with external parties. Provide Patient Safety expertise within the local Marketing company, tackling issue management for key products, risk management, and action plan formulation. Participate in ad-hoc local Marketing Company projects to drive success. Essential Skills/Experience: Degree Qualified Pharmacy/ Medical/ Science Pharmacovigilance knowledge excellence Good Pharmacovigilance Practice Language Expertise in Arabic / French Knowledge of health authority regulations Cross functional collaborative approach Effective and lateral thinking Problem solving Vendor management Excellent attention to detail Excellent written and verbal communication skills Desirable Skills/Experience: Influencing, and Conflict Resolution skills. Medical knowledge in company Therapeutic Areas Project management Successful participation in above-market projects Audit & Inspection experience When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. our work has a direct impact on patients' lives. We empower our teams to perform at their peak by combining cutting-edge science with leading digital technology platforms. Our commitment to innovation drives us to explore new ways of working, creating partnerships and ecosystems that deliver exponential growth. With a focus on data, analytics, AI, machine learning, and more, we are transforming healthcare and making a meaningful impact every day. Ready to take on this exciting challenge? Apply now and be part of a team that's changing lives!

Hi We are hiring for Leading ITES Company for PV Aggregate Reporting Profile. Skills a) Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing b) Experience is documents i.e., PBRER,PSUR,DSUR, ICH Guidelines b) Qualifications - Health Care Professional OR Masters/bachelors degree in Life Sciences/Physician Job Responsibility Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation Aggregate Safety Reports (PBRER, DSUR etc.) Eligibility: Minimum 2 years of medical writing work experience including 1 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) Working knowledge of MS Office applications Flexibility to work as per business requirements. Understands and interprets data/information and its practical application. Knowledge of industry and business principles related to biopharmaceutical products and combination products. Good interpersonal, verbal, and written communication skills Qualifications Health Care Professional OR Masters/bachelors degree in Life Sciences/Physician To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 54 b) To Apply for above Job Role ( Pune ) Type : Job Code # 55

Hi We are hiring for the ITES Company for the SAS : J Review Programmer Role Role & responsibilities Programming, specifically Programming, specifically J Review, SQL, R and GitHub. Good to have SAS. Create data cleaning reporting solutions study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. Develop library of reusable checks working closely with data engineers and config specialists. Collaborate with cross functional teams in creating business rules and automated check library across TAU. Serves as a technical resource for creating data analytics to help with data validation and cleaning. Provide programming expertise for data cleaning to efficiently ensure high quality data. Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable Technical skills and experience using relational databases (e.g. MS SQL Server, Redshift, or Oracle), EDC build and/or clinical data management experience preferred Experience in AWS preferred Experience setting up automated validation is preferred Knowledge of Data lake and creating interactive Dashboards are preferred Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.) To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Pune ) Type : Job Code # 89 b) To Apply for above Job Role ( Mumbai ) Type : Job Code # 90

Hi We are hiring for the ITES Company for the SAS : J Review Programmer Role Role & responsibilities Programming, specifically Programming, specifically J Review, SQL, R and GitHub. Good to have SAS. Create data cleaning reporting solutions study status metric, and monitoring reports and visualizations required per standard and study specific data review plans. Develop library of reusable checks working closely with data engineers and config specialists. Collaborate with cross functional teams in creating business rules and automated check library across TAU. Serves as a technical resource for creating data analytics to help with data validation and cleaning. Provide programming expertise for data cleaning to efficiently ensure high quality data. Ensure accurate delivery by creating macros for Standard listings for the department based on specifications. Develop programs that generate CRF and Query metrics, including ad-hoc Sponsor and internal programming requests. Ability to set up and configure analytics for coding reports, safety review and any risk-based monitoring activities. Operational experience in pharmaceutical drug development with significant direct exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.) Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable Technical skills and experience using relational databases (e.g. MS SQL Server, Redshift, or Oracle), EDC build and/or clinical data management experience preferred Experience in AWS preferred Experience setting up automated validation is preferred Knowledge of Data lake and creating interactive Dashboards are preferred Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.) To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Bangalore ) Type : Job Code # 87 b) To Apply for above Job Role ( Nagpur ) Type : Job Code # 88

Hi We are looking to hire Medical Data Reviewer for our Client. Please go through the JD and Apply. Responsibilities: Review subject/ patient level data for accuracy, to identify any anomalies, trends in patient reported data Review and provide inputs ion design of eCRF Review investigation product dosing Review all reported Adverse Events (AEs), Concomitant Medication and medical Ensure that any out of range data/ anomaly is verified Review all laboratory data on study subjects Review data in the form of visualizations and identify potential issues of concern Training new team members Qualifications: Bachelor/ Masters degree or equivalent in Life sciences/ Alternative Medicine (preferred) Eligibility: Good English communication skills Experience of handling clinical trial/ safety data - > 4 years To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 359 b) To Apply for above Job Role ( Pune ) Type : Job Code # 360 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 361