1738 Pharmacovigilance Jobs - Page 29

-Work with the marketing department to develop marketing strategies and materials Work closely with the medical information teams to make sure that information about all the companys products are available and current Provide support to regulatory affairs department for obtaining applicable product licenses Conduct analysis of competitors products as well as own product pipeline Work with medical technical writers for creation of marketing material, package inserts etc Participate in local and international meetings to represent the company Skills and Competencies: Excellent Leadership skills Negotiation skills Leadership skills Proactive Excellent communication skills Excellent knowledge of drug development and marketing concepts Educational Background: B.Pharma.

Role: Clinical Operations Business Consultant Required Technical Skill Set: Highly skilled with Veeva eTMF Application Experience: 5+ Yr Work Location: Mumbai, New Delhi, Indore, Bangalore, Hyderabad, Pune, Lucknow, Chennai, Kolkata Desired Competencies (Technical/Behavioral Competency) Must-Have: Experience with R&D specific IT application systems for Document management, trial management, Data management and/or Pharmacovigilance. Experience with data visualization and/or analytics tools and ability to build, program and modify new reports and visualizations. Experience with Clinical Trial related systems, e.g. Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF, preferably Veeva Vault), Electronic Data Capture (EDC, preferably Medidata RAVE) and Large Scale Data Analytics (such as SpotFire, CluePoints, JReview or similar). Highly proficient in Information Technology systems, including Microsoft Office suite. Proven record of working inside a team with different colleagues in any position, including being in the Lead. Being able to tailor feedback on compliance to different levels in the organization from Assistant roles to executive VP levels and in between. Knowledge of statistical methods and being able to apply that to detect outliers in data sets and/or to create thresholds such as Quality Tolerance Limits (QTLs) as required by ICH E6 (GCP) is a strong preference. Strong preference for candidates with a Project Management certificate and/or proven experience in project management for R&D related projects. Strong analytic skills for large quantities of compliance, risk management and clinical data. Strong interest in Pharmaceutical Development, mainly in the clinical research (R&D) aspects of drug development. Good-to-Have: Veeva Vault admin certification is required Experience with Veeva RIM Connectors is preferred Regulatory Information Management: Manage the lifecycle of regulatory submissions, including the preparation, tracking, and filing of documents in Veeva Vault RIM. Ensure that regulatory submissions comply with applicable local and international regulations and guidelines. Maintain and update regulatory documentation, including registration dossiers, variation applications, and compliance documents. System Configuration and Maintenance: Configure and customize Veeva Vault RIM to meet organizational needs, ensuring it aligns with regulatory requirements and workflows. Monitor system performance, troubleshoot issues, and coordinate with Veeva support for resolution. Data Management: Ensure the integrity and accuracy of regulatory data within Veeva Vault, including product information, submission statuses, and regulatory milestones. Implement data governance practices to maintain compliance and quality of regulatory data. Cross-Functional Collaboration: Collaborate with various teams, including Regulatory Affairs, Quality Assurance, Clinical Development, and Pharmacovigilance, to ensure timely and accurate regulatory submissions. Act as a point of contact for regulatory queries and provide training to internal teams on Veeva RIM functionalities. Regulatory Compliance: Stay updated on regulatory changes and ensure that the organization’s processes and systems comply with current regulations and industry best practices. Participate in audits and inspections as necessary, providing documentation and system access as required. Responsibility of / Expectations from the Role: Should be able to manage Regulatory information management VEEVA RIM & eTMF Demonstrated practical working experience in both processes (eg.xEVMPD) and untilisation of regulatory systems (RIMS, VEEVA) Handle Regulatory Affairs business processes Regulatory Information management VEEVA Vault RIM Align with Support Team on current issues and initiate problem management. Prepare and update application related documentation (Operational Instructions, User Manuals). Processes (eg.xEVMPD) and systems (eg.RIMS, VEEVA) Results-driven and pragmatic approach to work Good organizational skills, self-motivated and proactive Meticulous working style and high attitude to quality.

Project Role: Pharmacovigilance Tester Work Experience: 3+ years Work location: Noida, Hyderabad and Bangalore Mode of work: Hybrid Job Summary: The Argus/IVP Tester is responsible for ensuring the seamless integration, accuracy, and performance of safety data management systems, particularly in relation to Oracle Argus and IVP (Intake Validation Platform). The role involves designing, executing, and maintaining test cases and scenarios that validate data migration, transformation, and interface functionality between Argus and IVP. The tester will also work closely with cross-functional teams, including developers, business analysts, and project stakeholders, to identify and resolve defects, ensure compliance with regulatory requirements, and maintain high-quality deliverables. Essential Functions: 1. Test Planning and Design o Develop and document detailed test plans, test scenarios, and scripts for Argus and IVP data migration, transformation, and interface testing. o Create validation test protocols (VTPL) and user acceptance test (UAT) plans for system changes and updates. o Collaborate with business analysts to understand functional requirements and identify testing needs. 2. Test Execution o Perform end-to-end testing of data migration between Argus and IVP, ensuring accuracy and traceability of data transformations. o Execute test cases for system functionality, data validation, and interface integration across multiple environments. o Identify, log, and track defects to resolution while maintaining detailed documentation of testing outcomes. 3. Documentation and Reporting o Author and maintain standard operating procedures (SOPs), user functional requirement specifications (UFRS), and test execution summaries. o Generate and present comprehensive test reports, including defect analysis, risk assessments, and overall test coverage metrics. 4. Regulatory and Compliance o Ensure all testing activities comply with relevant regulatory standards, such as GxP and FDA 21 CFR Part 11. o Assist in preparing system validation documentation and support audits by providing testing artifacts and evidence. 5. Collaboration and Communication o Work closely with the development and tools teams to suggest design updates and improvements for system performance and usability. o Support change management processes, including Argus configuration changes and IVP intake modifications. o Act as a liaison between project stakeholders to align expectations and deliverables. 6. Continuous Improvement o Identify opportunities to improve testing processes, tools, and methodologies for enhanced efficiency and accuracy. o Stay updated with industry best practices, tools, and regulatory changes impacting Argus/IVP testing. .

Position Summary: The Drug Safety Physician will be responsible for the pharmacovigilance function, including medical review and oversight of processing for all types of safety events. The individual will provide clinical support of drug safety data management and interpretation and risk management activities for the company, including oversight of clinical trial Serious Adverse Event (SAE) processing and safety data analysis to support signal detection and risk/benefit profile evaluation. This individual will ensure timely, consistent, and accurate safety reporting in accordance with FDA, EMA, and ICH guidelines, applicable regulatory requirements, Good Clinical Practice (GCP) and standard operating procedures (SOPs). Responsibilities (including but not limited to): Manage all aspects of Drug Safety and Pharmacovigilance, including leadership of safety data review, signal detection, risk communication including safety information updates, and mitigation of potential risks Provide medical and drug safety expertise to enable decision-making based on ongoing risk-benefit assessment, clinical trial data interpretation, and medical review of individual case reports of SAEs Work with CRO Safety Physicians/Team and Dragonfly’s Medical Directors, Clinical Scientists and other functions on safety monitoring, assessment and reporting activities (case and aggregate) Input on safety sections in cross-functional documents (eg, study protocols, study reports, IBs, ICFs) and on responses to safety-related questions from regulatory agency, IRBs and Ethics Committees Act as the point of contact accountable for setting up and running DSMBs or safety data review meetings Participate in routine safety cohort reviews for ongoing Phase 1 dose escalation studies Perform event coding review and clinical & safety database reconciliation for consistent coding Oversee and manage Drug Safety system(s) to ensure compliance with safety data management and reporting requirements in all relevant territories and optimized safety database ownership and access for safety monitoring, signal detection and reporting Ensure effective SOPs and strong safety vendor governance are in place Proactively recommend and plan for future development of Drug Safety and Pharmacovigilance to enable regulatory filings and commercialization, including acquiring QPPV support and the participation in creating Risk Management Plans and a Pharmacovigilance System Master File Ensure audit and inspection readiness of the function at all times Education and Skills Required: MD required, with a minimum of 7 years in Drug Safety related activities in pharma/biotech (title commensurate with experience) Clinical trial experience, including oncology drug safety with least 3 years being in early clinical development Experience authoring, reviewing, and providing input to drug-safety related regulatory reports Successful involvement in regulatory agency interactions or inspections Strong knowledge of FDA, EU, ICH and other global regulatory requirements for safety reporting and safety data and risk management Solid medical knowledge and familiarity with medical concepts and terminology used in hematology/oncology clinical trials and safety monitoring Proficiency with using standard computer applications (eg Microsoft Office, Windows) and safety databases Possesses a sense of urgency and an ability to anticipate and respond quickly to emerging information Excellent oral and written communication skills for effectively interfacing with vendors and internal stakeholders Fosters strong relationships and values collaboration to develop and execute on plans Ability to multi-task in a fast-paced environment Self-motivated, conscientious, and enthusiastic about curing human diseases Other Required: Experience with case processing in ARGUS Demonstrated ability to challenge existing practices to become more effective. Ability to effectively adapt to a variety of situations. Meet quality and performance standards. Strong influencing skills Excellent communication skills, both written and oral Work effectively as a team member and promotes collaboration. Demonstrate ownership, initiative and accountability. Supervisory experience Less than 20% travel. Competencies: Ability to deliver on commitments and understanding of service culture. Communicates effectively and efficiently on safety issues to internal and external stakeholders. Maintain consistency of safety assessments. Serve in cross-functional teams as Drug Safety expert. Monitor regulatory compliance of safety reporting throughout trial. Lead and contribute to process development and/or process improvements that support Drug Safety Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Bangalore Karnataka India Job Type: Regular Full-time Division: Precision for Medicine Business Unit: Clinical Solutions Requisition Number: 5781 Position Summary: The Drug Safety Physician will be responsible for the pharmacovigilance function, including medical review and oversight of processing for all types of safety events. The individual will provide clinical support of drug safety data management and interpretation and risk management activities for the company, including oversight of clinical trial Serious Adverse Event (SAE) processing and safety data analysis to support signal detection and risk/benefit profile evaluation. This individual will ensure timely, consistent, and accurate safety reporting in accordance with FDA, EMA, and ICH guidelines, applicable regulatory requirements, Good Clinical Practice (GCP) and standard operating procedures (SOPs). Responsibilities (including but not limited to): Manage all aspects of Drug Safety and Pharmacovigilance, including leadership of safety data review, signal detection, risk communication including safety information updates, and mitigation of potential risks Provide medical and drug safety expertise to enable decision-making based on ongoing risk-benefit assessment, clinical trial data interpretation, and medical review of individual case reports of SAEs Work with CRO Safety Physicians/Team and Dragonfly’s Medical Directors, Clinical Scientists and other functions on safety monitoring, assessment and reporting activities (case and aggregate) Input on safety sections in cross-functional documents (eg, study protocols, study reports, IBs, ICFs) and on responses to safety-related questions from regulatory agency, IRBs and Ethics Committees Act as the point of contact accountable for setting up and running DSMBs or safety data review meetings Participate in routine safety cohort reviews for ongoing Phase 1 dose escalation studies Perform event coding review and clinical & safety database reconciliation for consistent coding Oversee and manage Drug Safety system(s) to ensure compliance with safety data management and reporting requirements in all relevant territories and optimized safety database ownership and access for safety monitoring, signal detection and reporting Ensure effective SOPs and strong safety vendor governance are in place Proactively recommend and plan for future development of Drug Safety and Pharmacovigilance to enable regulatory filings and commercialization, including acquiring QPPV support and the participation in creating Risk Management Plans and a Pharmacovigilance System Master File Ensure audit and inspection readiness of the function at all times Education and Skills Required: MD required, with a minimum of 7 years in Drug Safety related activities in pharma/biotech (title commensurate with experience) Clinical trial experience, including oncology drug safety with least 3 years being in early clinical development Experience authoring, reviewing, and providing input to drug-safety related regulatory reports Successful involvement in regulatory agency interactions or inspections Strong knowledge of FDA, EU, ICH and other global regulatory requirements for safety reporting and safety data and risk management Solid medical knowledge and familiarity with medical concepts and terminology used in hematology/oncology clinical trials and safety monitoring Proficiency with using standard computer applications (eg Microsoft Office, Windows) and safety databases Possesses a sense of urgency and an ability to anticipate and respond quickly to emerging information Excellent oral and written communication skills for effectively interfacing with vendors and internal stakeholders Fosters strong relationships and values collaboration to develop and execute on plans Ability to multi-task in a fast-paced environment Self-motivated, conscientious, and enthusiastic about curing human diseases Other Required: Experience with case processing in ARGUS Demonstrated ability to challenge existing practices to become more effective. Ability to effectively adapt to a variety of situations. Meet quality and performance standards. Strong influencing skills Excellent communication skills, both written and oral Work effectively as a team member and promotes collaboration. Demonstrate ownership, initiative and accountability. Supervisory experience Less than 20% travel. Competencies: Ability to deliver on commitments and understanding of service culture. Communicates effectively and efficiently on safety issues to internal and external stakeholders. Maintain consistency of safety assessments. Serve in cross-functional teams as Drug Safety expert. Monitor regulatory compliance of safety reporting throughout trial. Lead and contribute to process development and/or process improvements that support Drug Safety It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Any data provided as a part of this application will be stored in accordance with our Privacy Policy. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2021 Precision Medicine Group, LLC. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.

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 lie within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Group Purpose Integrated Signal Management group is responsible for the direction and strategy for safety signal detection and management, safety governance, and quality complaints trending and analytics. It drives policies, research, definition and implementation of innovation and best practices for safety data mining, signal detection planning, management, tracking, product complaints trending and analytics; risk management practices, benefit/risk assessment and safety communications while ensuring quality processes with proven metrics. Job Summary The Innovation Specialist will serve as a key strategic partner within the Signal Management and Post-Market Surveillance & Trending organization, focused on identifying, evaluating, and implementing emerging technologies and AI/ML-enabled analytical tools in collaboration with the ISM Data Science team. This role will bridge scientific, technical, and business functions to co-develop innovative surveillance capabilities that monitor the safety and quality of Amgen products. Key Activities Technology Scouting & Evaluation - Monitor and evaluate industry trends, emerging technologies, academic research, and vendor solutions related to AI/ML for post-market safety and product complaints surveillance. Maintain a landscape of external vendors offering signal detection, NLP, and data analytics solutions relevant to product surveillance. Collaboration & Innovation Development - Partner with the ISM Data Science team to assess feasibility, develop prototypes, and deploy AI/ML models for signal detection and augmentation of signal assessment Engage with stakeholders (e.g., TA Safety) to identify unmet needs and prioritize use cases. Facilitate workshops or ideation sessions to shape innovation roadmaps and pilot initiatives. Promote adoption of industry best practices and ensure compliance with regulatory guidance on AI/ML and surveillance in the context of combination products. Perform regulatory impact and risk analysis of proposed solutions Develop internal guidelines and documentation for use of advanced analytics in surveillance activities. Project Execution - Lead or support proof-of-concept and pilot initiatives for new surveillance technologies. Translate business needs into functional requirements for solution development. Track project progress, manage risks, and report findings to senior leadership. Knowledge And Skills Required Knowledge and Skills: Experience in post-market surveillance, pharmacovigilance, medical device vigilance, or related domain Knowledge of combination products and medical devices, including device safety monitoring regulations and standards Knowledge of software development concepts Experience with market scanning, vendor/product evaluation Knowledge of regulatory framework and guidance of principles for AI in the medicinal product lifecycle Preferred Knowledge and Skills: Demonstrated experience working with or evaluating AI/ML tools, safety analytics, natural language processing (NLP), or data mining. Strong project management, cross-functional collaboration, and communication skills Education & Experience 8-13 years of industry experience Experience with market scanning, vendor/product evaluation Experience working with AI/ML and/or automation tools Strong project management, cross-functional collaboration, and communication skills What You Can Expect From 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 with 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.

About Amgen Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. 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 next generation of safety platforms and supporting technologies. In this role, you will engage with business users and functional SMEs, driving the delivery of innovative technology solutions that enhance business outcomes. Areas of focus will be on leading team performance, delivery management, mentorship, and facilitating continuous improvement in both technical skills and user experience. This is a first-level management role that requires hands-on leadership to develop your team’s capabilities while aligning with business needs and strategic goals. Roles & Responsibilities: Partner with IS and Business collaborators to understand how automation can improve workflow and efficiency; ensuring solutions meet business needs. Lead the day-to-day operations and maintenance of Pharmacovigilance systems (safety database). Find other opportunities for automation and process improvements within the Safety ecosystem. Overall accountability of technical implementation aspects of projects including planning, architecture, design, development, and testing to follow IS Change Control and GxP validation process. Part of project/product team, willing to jump in and do programming/code-reviews etc. based on demands. Hands on programming (SQL/Scripts) is expected. Work closely with the delivery and platform teams to ensure that the applications are aligned with approved architectural and development guidelines. Keeps updated on industry trends, emerging trends and standard processes for pharmacovigilance systems. Maintain knowledge of market trends and developments in web application development frameworks and related and new technologies to provide, recommend, and deliver standard methodology solutions. Responsible for supporting and leading technical root cause analysis and works with vendors to resolve Pharmacovigilance systems related issues. Responsible for improving performance by coaching, mentorship, and training to develop both technical and professional skills within the team. Support audits and inspections. What We Expect Of You We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master’s degree with 4 - 6 years of experience in Computer Science, IT or related field OR Bachelor’s degree with 6 - 8 years of experience in Computer Science, IT or related field OR Diploma with 10 - 12 years of experience in Computer Science, IT or related field. Excellent problem-solving skills and a passion for tackling complex challenges. Collaborative spirit and effective communication skills to work seamlessly in a multi-functional team. An ongoing commitment to learning and staying at the forefront of AI/ML advancements. Experienced in AI/ML technologies and staying at the forefront of AI/ML advancements. 5 + years of experience COTS Pharmacovigilance Platforms (for example Argus) is a plus or other safety database. 2+ years of management or leadership experience or leadership of or leading a team of technical experts . Preferred Qualifications: Experienced in database programming languages, data modelling concepts, including Oracle SQL and PL/SQL. Experience with API integrations such as MuleSoft. Solid understanding of using one or more general programming languages, including but not limited to: Java or Python. Outstanding written and verbal communication skills, and ability to explain technical concepts to non-technical clients. Sharp learning agility, problem solving and analytical thinking . Experienced in managing GxP systems and implementing GxP projects. Extensive expertise in SDLC, including requirements, design, testing, data analysis, change control. Professional Certifications: SAFe for Teams certification (preferred) SAFe Product Owner and SAFe Product Manager (preferred) Soft Skills: Excellent analytical and troubleshooting skills. Excellent leadership and critical thinking abilities. Strong verbal and written communication skills. Ability to work effectively with global, virtual teams . High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Strong presentation and public speaking skills. Ability to deal with ambiguity and think on their feet. Ability to influence and drive to an intended outcome. Ability to hold team members accountable to commitments. Shift Information: This position requires 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. EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with 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 an accommodation.

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 lie within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Group Purpose Group is accountable for global literature surveillance activities for all Amgen portfolio of products. Responsible for performing the weekly review of literature articles for signal detection and identification of safety reports. Job Summary This position is responsible for performing routine weekly reviews of literature articles retrieved from Embase, Medline, and BIOSIS, which are the bibliographic databases used for Amgen’s global literature surveillance. The review supports signal detection for all Amgen portfolio of products and identification of individual case safety reports (ICSRs) for marketed products. Key Responsibilities: Literature Management Process - Perform review of literature results retrieved and imported into literature citation management system on a weekly basis and determine if minimum criteria for ICSR is met for marketed products Perform review of literature results to determine if article contains new aggregate safety information in support of the periodic report and/or signal detection Determine whether full text article needs to be ordered and order them if further information is needed to confirm if the citation meets criteria for ICSR or for signal detection Flag articles containing new aggregate safety information for TA Safety to perform secondary review Request Local Safety Officer to provide English translation if the article is not in English Notify business partner of articles received, if applicable Perform retrospective quality checks on the quality of the literature review performed by team Support audits and inspections Collaborate with Case Management and TA Safety on process improvement initiatives Proactively proposes and system and process improvement ideas Provide training and onboarding to junior staff Perform Quality checks on literature reviews performed by other staff Periodic Reporting Process - May assist with quality control of periodic reporting activities as required. Extract list of citations for inclusion in periodic reports Key Activities Responsible for routine review of literature articles as part of the global literature surveillance process Assist with quality control of periodic reporting activities Support audits and inspections by extracting requested citations from literature citation management system Knowledge And Skills Knowledge of product profiles for products assignment Ability to identify literature articles containing ICSR criteria or aggregate safety findings supporting signal detection Ability to order full text articles where needed Ability to receive feedback from Case Management and TA Safety and optimize quality of literature review Demonstrate knowledge of global aspects of pharmacovigilance Strong knowledge of processes and global regulations for pharmacovigilance and literature surveillance Ability to effectively manage competing priorities and timelines Strong knowledge of literature citation management systems and platform used to configure search strategies Experience in use of AI and prompts would be useful CONTRIBUTION: Ensures Amgen remains in compliance and maintains high quality global literature review process Responsible for the timely completion of review of weekly literature results Education & Experience (Basic) 8-13 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting Knowledge of bibliographic databases and direct literature review experience (preferred) What You Can Expect From 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 with 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.

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. Pharmacovigilance Operations Senior Mgr What You Will Do This role supports the end-to-end writing and documentation process and ensures timelines are met. Provide audit & external inspection support as required. Key Responsibilities: Periodic Report Process: Supervision of a team of Periodic Report Managers in Amgen India with Periodic Report responsibilities Organise the end-to-end process of report production and ensure the required quality standards and key timelines are met. Provide oversight to co-authors as applicable and be accountable for the quality of their work. Act as main point of contact for Director of PASR on all Periodic Aggregate Safety Report work Act as a writing coach, provide regular quality feedback, and share standard processes with team for promoting the use of clear and concise writing and alignment to style guides and templates as applicable. Support project management activities, including estimation of resource requirement. Implement and promote use of consistent, efficient and quality processes to meet timelines and work according to requirements and SOPs and assume accountability for the work Ensure compliance of operations with governing regulatory requirements. Analysis and communication of PASR quality with Director of PASR team Customer concern of issues around quality and KPIs to Director of PASR Provide metrics for audit/inspection support for PASR related activities Literature Management Process Supervision of a team of Literature review scientists Responsible for the business process of and oversight of the global literature review process Responsible for engagement and oversight of system vendors supporting the global literature review process Responsible for training and onboarding of literature review team Responsible for the proposal, generation, and maintenance of metrics and/or KPI/KCIs related to global literature review Stay ahead of technology and innovation to improve the efficiency and quality of scientific literature search and review Collaborate with TA Safety and Case Management on process and system improvement opportunities What We Expect Of You We are all different, yet we all use our unique contributions to serve patients. The professional we seek is someone with these qualifications. Basic Qualifications: Doctorate degree / Master's degree / Bachelor's degree and 12 to 17 years of relevant experience Preferred Qualifications: Handling direct reports on a day-to-day basis and raising topics as needed to Director of PASR team Work within the Quality Management System framework including all applicable training and controlled documentation governing Pharmacovigilance processes Responsible for the growth and development of direct reports Ensure monthly review of performance metrics for the PASR process. Build and maintain good functional and multi-functional relationships globally Inspection Readiness: Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Support audit and inspection work, including but not limited to information requests and response QC. Extensive knowledge of global regulatory requirements for Pharmacovigilance Extensive knowledge of global PASR requirements Extensive knowledge of authoring PASRs Extensive people management experience Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment Understands and interprets data/information and its practical application Knowledge of scientific/technical writing and editing Excellent English written/oral communication, and strong time and project management skills strategic mentality, attention to detail, and the ability to work multi-functionally across multiple teams to ensure compliance, operational efficiency, and continuous improvement within Pharmacovigilance Operations. Demonstrate knowledge of global aspects of pharmacovigilance Strong knowledge of processes and global regulations for pharmacovigilance and periodic / aggregate reporting Ability to effectively handle challenging priorities and timelines Strong leadership skills, independence, networking and influencing skills Computer literate: knowledge of MS work, PowerPoint, Adobe Acrobat, MS Excel, SharePoint and Document Management Systems e.g. Veeva Vault Experience in use of AI and prompts would be useful What You Can Expect Of Us As we work to develop treatments that look after 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. Please contact us to request accommodation.

Career Category Safety 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. Pharmacovigilance Operations Senior Mgr What you will do This role supports the end-to-end writing and documentation process and ensures timelines are met. Provide audit external inspection support as required. Key Responsibilities: Periodic Report Process: Supervision of a team of Periodic Report Managers in Amgen India with Periodic Report responsibilities Organise the end-to-end process of report production and ensure the required quality standards and key timelines are met. Provide oversight to co-authors as applicable and be accountable for the quality of their work. Act as main point of contact for Director of PASR on all Periodic Aggregate Safety Report work Act as a writing coach, provide regular quality feedback, and share standard processes with team for promoting the use of clear and concise writing and alignment to style guides and templates as applicable. Support project management activities, including estimation of resource requirement. Implement and promote use of consistent, efficient and quality processes to meet timelines and work according to requirements and SOPs and assume accountability for the work Ensure compliance of operations with governing regulatory requirements. Analysis and communication of PASR quality with Director of PASR team Customer concern of issues around quality and KPIs to Director of PASR Provide metrics for audit/inspection support for PASR related activities Literature Management Process Supervision of a team of Literature review scientists Responsible for the business process of and oversight of the global literature review process Responsible for engagement and oversight of system vendors supporting the global literature review process Responsible for training and onboarding of literature review team Responsible for the proposal, generation, and maintenance of metrics and/or KPI/KCIs related to global literature review Stay ahead of technology and innovation to improve the efficiency and quality of scientific literature search and review Collaborate with TA Safety and Case Management on process and system improvement opportunities What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is someone with these qualifications. Basic Qualifications: Doctorate degree / Masters degree / Bachelors degree and 12 to 17 years of relevant experience Preferred Qualifications: Handling direct reports on a day-to-day basis and raising topics as needed to Director of PASR team Work within the Quality Management System framework including all applicable training and controlled documentation governing Pharmacovigilance processes Responsible for the growth and development of direct reports Ensure monthly review of performance metrics for the PASR process. Build and maintain good functional and multi-functional relationships globally Inspection Readiness: Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Support audit and inspection work, including but not limited to information requests and response QC. Extensive knowledge of global regulatory requirements for Pharmacovigilance Extensive knowledge of global PASR requirements Extensive knowledge of authoring PASRs Extensive people management experience Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment Understands and interprets data/information and its practical application Knowledge of scientific/technical writing and editing Excellent English written/oral communication, and strong time and project management skills strategic mentality, attention to detail, and the ability to work multi-functionally across multiple teams to ensure compliance, operational efficiency, and continuous improvement within Pharmacovigilance Operations. Demonstrate knowledge of global aspects of pharmacovigilance Strong knowledge of processes and global regulations for pharmacovigilance and periodic / aggregate reporting Ability to effectively handle challenging priorities and timelines Strong leadership skills, independence, networking and influencing skills Computer literate: knowledge of MS work, PowerPoint, Adobe Acrobat, MS Excel, SharePoint and Document Management Systems e. g. Veeva Vault Experience in use of AI and prompts would be useful What you can expect of us As we work to develop treatments that look after others, we also work to care for your professional and personal growth and we'll-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. Please contact us to request accommodation. .

We are seeking a dedicated and experienced Nurse for our Emergency Room (ER) at Manipal Hospitals. The ideal candidate will provide high-quality, compassionate care to patients presenting with acute medical conditions in a fast-paced environment. The ER Nurse will be responsible for assessing patient needs, implementing nursing interventions, and collaborating with physicians and other healthcare professionals to ensure optimal patient outcomes. Roles and Responsibilities About the Role: As a Nurse in the Emergency Room at Manipal Hospitals, you will play a critical role in providing immediate and effective care to patients experiencing acute medical conditions. Your responsibilities will include assessing patient needs, administering medications, and supporting doctors during emergencies. You will also contribute to the overall efficiency of the ER by managing triage processes and ensuring all equipment and supplies are readily available. About the Team: You will be part of a dynamic and multidisciplinary healthcare team that includes physicians, specialists, and other nursing staff. The team is dedicated to delivering high-quality care in a fast-paced environment. Collaboration and communication are essential, as you will work closely with your colleagues to manage patient care effectively and respond to emergencies. You are Responsible for: - Assessing and monitoring patients' conditions accurately in a timely manner. - Administering medications and treatments according to established protocols. - Assisting in various emergency procedures and interventions. - Maintaining accurate patient records and documentation for all treatments provided. - Educating patients and their families about post-treatment care and follow-up. To succeed in this role – you should have the following: - A valid nursing license and relevant certifications in Basic Life Support (BLS) and Advanced Cardiac Life Support (ACLS). - Experience in an emergency room or acute care setting is preferred. - Strong critical thinking and problem-solving skills to make quick decisions. - Excellent communication and interpersonal skills to interact effectively with patients and their families. - Ability to work under pressure and manage multiple priorities in a fast-paced environment.

Aster Medcity is looking for Pharmacist.Pharmacy to join our dynamic team and embark on a rewarding career journey Compounding and dispensing medications, as prescribed by physicians. Monitoring customers drug therapies, advising interventions, and informing customers of any potential side effects. Instructing customers on how and when to take prescribed medications. Conducting health and wellness screenings. Providing immunizations, and other medical services, such as taking blood pressure, temperature measurements, and checking blood sugar levels. Keeping accurate customer records. Ensuring a safe and clean working environment. Completing operational requirements of the pharmacy, including verifying order entries, maintaining records of controlled substances, charges, and removing expired and/or damaged drugs from the pharmacys inventory. Adhering to applicable legal rules, regulations, and procedures governing pharmaceutical practice. Performing other administrative tasks when needed.

Job Description Technical Support Engineer - Python About ArisGlobal ( www.arisglobal.com ): ArisGlobal is empowering life science organizations to deliver breakthroughs faster , accurately , and with precision. This is paramount for the passage of lifesaving medications and products VIA clinical trials, using our software and technology. As an industry leader, ArisGlobal provides our SaaS leading technology and services to 40/50 top Bio-pharmaceutical corporations, 4/5 of the most advanced global pharmaceutical companies and nine government-health authorities, including the FDA, Health Canada and the NMPA, for example, around the world. 2021 has presented simultaneous developments in the global Drug Safety and Pharmacovigilance Software Market, projecting unfaltering growth through 2027. Effectively harnessed by prominent market drivers, ArisGlobal is named a Key Player. Located in Miami, New Jersey, Budapest, Dublin, Darmstadt, Rome, Tokyo, Shanghai, Bangalore, Mysore, our global presence is clear, and we are growing faster than ever . Requirements: Bachelor s degree in computer science, Information Technology. 2-6 years of experience in Technical Support/Application Support and IT service management, preferably in a global organization. Minimum 1+ Years of strong experience in Python (Mandatory) Good SQL (OR) PL/SQL skills To fetch case data based on customer requirements. To write update statements on scenario basis for case correction. Should be ready work in 24X7 shift based support team Strong knowledge of IT service management frameworks (ITIL) and best practices. Proven track record in driving support excellence and customer satisfaction. Experience in managing customer service level agreements. Excellent analytical, problem-solving, and decision-making skills. Strong leadership and interpersonal skills, with the ability to collaborate effectively across teams and influence stakeholders. Collaborative mindset and the ability to work seamlessly within diverse teams and drive concept implementation. Exceptional communication and presentation skills, both written and verbal. Working knowledge with ticketing tools like Jira, ZenDesk, ServiceNow. Roles & Responsibilities: As Tier-2 engineer for you would be responsible for providing application functionality support and technical support for ArisGlobal Life Sphere applications, associated interfaces or any other product of ArisGlobal. Take ownership of tickets logged by customer and delivery excellent customer experience that meets ArisGlobal organizational values Collaborate with cross-functional teams and support Service Delivery managers to establish service delivery standards and best practices, ensuring alignment with business objectives. Monitor and analyse service performance using industry-leading methodologies, identify areas for improvement, and implement corrective actions. Lead/Collaborate in service improvement initiatives, leveraging continuous improvement methodologies and frameworks. Oversee incident and problem management processes, ensuring timely resolution and minimizing impact on operations. Foster a culture of customer-centricity within the organization, promoting a high level of customer service and engagement. Good To have skills: Good understanding of Pharmacovigilance Added advantage if you possess the below listed experience or similar enterprise products experience. Working knowledge with case processing life cycle from case creation to distribution.

Job Description Technical Support Engineer About ArisGlobal ( www.arisglobal.com ): ArisGlobal is empowering life science organizations to deliver breakthroughs faster , accurately , and with precision. This is paramount for the passage of lifesaving medications and products VIA clinical trials, using our software and technology. As an industry leader, ArisGlobal provides our SaaS leading technology and services to 40/50 top Bio-pharmaceutical corporations, 4/5 of the most advanced global pharmaceutical companies and nine government-health authorities, including the FDA, Health Canada and the NMPA, for example, around the world. 2021 has presented simultaneous developments in the global Drug Safety and Pharmacovigilance Software Market, projecting unfaltering growth through 2027. Effectively harnessed by prominent market drivers, ArisGlobal is named a Key Player. Located in Miami, New Jersey, Budapest, Dublin, Darmstadt, Rome, Tokyo, Shanghai, Bangalore, Mysore, our global presence is clear, and we are growing faster than ever . Requirements: Bachelor s degree in computer science, Information Technology. 2-4 years of experience in Technical Support/Application Support and IT service management, preferably in a global organization. Good SQL (OR) PL/SQL skills To fetch case data based on customer requirements. To write update statements on scenario basis for case correction. Should be ready work in 24X7 shift based support team Strong knowledge of IT service management frameworks (ITIL) and best practices. Proven track record in driving support excellence and customer satisfaction. Experience in managing customer service level agreements. Excellent analytical, problem-solving, and decision-making skills. Strong leadership and interpersonal skills, with the ability to collaborate effectively across teams and influence stakeholders. Collaborative mindset and the ability to work seamlessly within diverse teams and drive concept implementation. Exceptional communication and presentation skills, both written and verbal. Working knowledge with ticketing tools like Jira, ZenDesk, ServiceNow. Roles & Responsibilities: As Tier-2 engineer for you would be responsible for providing application functionality support and technical support for ArisGlobal Life Sphere applications, associated interfaces or any other product of ArisGlobal. Take ownership of tickets logged by customer and delivery excellent customer experience that meets ArisGlobal organizational values Collaborate with cross-functional teams and support Service Delivery managers to establish service delivery standards and best practices, ensuring alignment with business objectives. Monitor and analyse service performance using industry-leading methodologies, identify areas for improvement, and implement corrective actions. Lead/Collaborate in service improvement initiatives, leveraging continuous improvement methodologies and frameworks. Oversee incident and problem management processes, ensuring timely resolution and minimizing impact on operations. Foster a culture of customer-centricity within the organization, promoting a high level of customer service and engagement. Good To have skills: Good understanding of Pharmacovigilance Added advantage if you possess the below listed experience or similar enterprise products experience. Working knowledge with case processing life cycle from case creation to distribution.

Work Schedule Standard (Mon-Fri) Environmental Conditions Office At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. Purpose: Subject matter expert of day-to-day application configuration and maintenance activities of the Pharmacovigilance (PV) Safety database Oracle Argus, ensuring that performed tasks comply with SOPs and policies, industry standards, and applicable regulations. Provides technical solutions, support systems implementation and testing following change control procedures and provide systems administration to support the requirements and initiatives of the PV Safety group. Responsibilities include but are not limited to: Collaborates with PV business users to understand the requirements and recommend solutions. Creates custom and ad-hoc reports from the PV Safety database using built in tools, OBIEE, or SQL. Develops and validates aggregate safety reports. Troubleshoots and addresses end user queries related to the Safety database. Supports routine dictionary upgrades. Liaises with PV Safety database vendor for system upgrades and enhancements, issue resolutions and on-going projects. Assists in the development of SOPs for the PV Safety database. Assists with internal and external audits of the PV Safety database. Manages changes to the PV Safety database under PPD change control policy, including configuration changes and system upgrades. Creates new tenants within the PV Safety database. Develops distribution rule configurations within the PV Safety database. Leads data migration and validation projects including creation of Data Migration Plans, Design Specifications and Summary Reports to ensure data migration activities meet requirements, are complete and accurate and delivered to a high-quality. Interacts with project team or client and seeks feedback on deliverables. Provides programming support to project teams and clients for safety data review, ad-hoc reports and other activities. Leads project initiatives as needed, ensures desired outcome is achieved on time and in scope. Reviews and makes recommendations for process development and improvement. Manages assignment to meet timelines and deliver high quality work. Estimates effort to assist in bidding activities or cost construction. Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years) Knowledge, Skills and Abilities: System administration experience in Oracle Argus including current knowledge of safety system configuration, database structure, mappings requirements and transformation rules Strong experience generating reports Strong SQL programming skills Demonstrable record in safety data migrations Knowledge of relational data base structure and experience working with complex data systems Proficient of one or more programming languages Strong attention to detail Problem solving skills Good written and verbal communications skills Ability to independently and effectively organize and manage multiple assignments with challenging timelines Ability to adapt and adjust to changing priorities Demonstrated leadership, initiative and motivation Ability to mentor and direct the work of junior staff Ability to communicates effectively within a multi-disciplinary team Ability to complete assigned tasks on time and within budget Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Apply today! http://jobs.thermofisher.com Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

M.Pharm fresher job description typically involves entry-level roles in pharmaceutical research and development, quality control, regulatory affairs, or pharmacovigilance. Responsibilities may include assisting with formulation development, conducting quality control tests, contributing to regulatory submissions, or monitoring drug safety. Skills in pharmaceutical sciences, analytical techniques, and regulatory requirements are often sought. Here's a more detailed breakdown:Job Titles: Junior Formulation Development Associate: Focuses on assisting with the development of new drug formulations. Quality Control Chemist/Analyst: Involves conducting quality control tests on raw materials, in-process samples, and finished products. IPQA Officer: Ensures quality during the manufacturing process. Pharmacist: Dispenses medications, provides patient counseling, and manages pharmacy operations. Research Associate: Assists with research projects, data collection, and analysis. Medical Representative: Promotes pharmaceutical products to healthcare professionals. Job Types: Full-time, Permanent, Fresher Pay: ₹16,000.00 - ₹20,000.00 per month Benefits: Health insurance Paid time off Provident Fund Schedule: Day shift Morning shift Rotational shift Supplemental Pay: Overtime pay Yearly bonus Work Location: In person

India - Hyderabad JOB ID: R-217738 ADDITIONAL LOCATIONS: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: Jun. 27, 2025 CATEGORY: Information Systems ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. 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 next generation of safety platforms and supporting technologies. In this role, you will engage with business users and functional SMEs, driving the delivery of innovative technology solutions that enhance business outcomes. Areas of focus will be on leading team performance, delivery management, mentorship, and facilitating continuous improvement in both technical skills and user experience. This is a first-level management role that requires hands-on leadership to develop your team’s capabilities while aligning with business needs and strategic goals. Roles & Responsibilities: Partner with IS and Business collaborators to understand how automation can improve workflow and efficiency; ensuring solutions meet business needs. Lead the day-to-day operations and maintenance of Pharmacovigilance systems (safety database). Find other opportunities for automation and process improvements within the Safety ecosystem. Overall accountability of technical implementation aspects of projects including planning, architecture, design, development, and testing to follow IS Change Control and GxP validation process. Part of project/product team, willing to jump in and do programming/code-reviews etc. based on demands. Hands on programming (SQL/Scripts) is expected. Work closely with the delivery and platform teams to ensure that the applications are aligned with approved architectural and development guidelines. Keeps updated on industry trends, emerging trends and standard processes for pharmacovigilance systems. Maintain knowledge of market trends and developments in web application development frameworks and related and new technologies to provide, recommend, and deliver standard methodology solutions. Responsible for supporting and leading technical root cause analysis and works with vendors to resolve Pharmacovigilance systems related issues. Responsible for improving performance by coaching, mentorship, and training to develop both technical and professional skills within the team. Support audits and inspections. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master’s degree with 4 - 6 years of experience in Computer Science, IT or related field OR Bachelor’s degree with 6 - 8 years of experience in Computer Science, IT or related field OR Diploma with 10 - 12 years of experience in Computer Science, IT or related field. Excellent problem-solving skills and a passion for tackling complex challenges. Collaborative spirit and effective communication skills to work seamlessly in a multi-functional team. An ongoing commitment to learning and staying at the forefront of AI/ML advancements. Experienced in AI/ML technologies and staying at the forefront of AI/ML advancements. 5 + years of experience COTS Pharmacovigilance Platforms (for example Argus) is a plus or other safety database. 2+ years of management or leadership experience or leadership of or leading a team of technical experts . Preferred Qualifications: Experienced in database programming languages, data modelling concepts, including Oracle SQL and PL/SQL. Experience with API integrations such as MuleSoft. Solid understanding of using one or more general programming languages, including but not limited to: Java or Python. Outstanding written and verbal communication skills, and ability to explain technical concepts to non-technical clients. Sharp learning agility, problem solving and analytical thinking . Experienced in managing GxP systems and implementing GxP projects. Extensive expertise in SDLC, including requirements, design, testing, data analysis, change control. Professional Certifications: SAFe for Teams certification (preferred) SAFe Product Owner and SAFe Product Manager (preferred) Soft Skills: Excellent analytical and troubleshooting skills. Excellent leadership and critical thinking abilities. Strong verbal and written communication skills. Ability to work effectively with global, virtual teams . High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Strong presentation and public speaking skills. Ability to deal with ambiguity and think on their feet. Ability to influence and drive to an intended outcome. Ability to hold team members accountable to commitments. Shift Information: This position requires 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. EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with 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 an accommodation.

India - Hyderabad JOB ID: R-218842 ADDITIONAL LOCATIONS: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: Jun. 27, 2025 CATEGORY: Safety 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. Pharmacovigilance Operations Senior Mgr What you will do This role supports the end-to-end writing and documentation process and ensures timelines are met. Provide audit & external inspection support as required. Key Responsibilities: Periodic Report Process: Supervision of a team of Periodic Report Managers in Amgen India with Periodic Report responsibilities Organise the end-to-end process of report production and ensure the required quality standards and key timelines are met. Provide oversight to co-authors as applicable and be accountable for the quality of their work. Act as main point of contact for Director of PASR on all Periodic Aggregate Safety Report work Act as a writing coach, provide regular quality feedback, and share standard processes with team for promoting the use of clear and concise writing and alignment to style guides and templates as applicable. Support project management activities, including estimation of resource requirement. Implement and promote use of consistent, efficient and quality processes to meet timelines and work according to requirements and SOPs and assume accountability for the work Ensure compliance of operations with governing regulatory requirements. Analysis and communication of PASR quality with Director of PASR team Customer concern of issues around quality and KPIs to Director of PASR Provide metrics for audit/inspection support for PASR related activities Literature Management Process Supervision of a team of Literature review scientists Responsible for the business process of and oversight of the global literature review process Responsible for engagement and oversight of system vendors supporting the global literature review process Responsible for training and onboarding of literature review team Responsible for the proposal, generation, and maintenance of metrics and/or KPI/KCIs related to global literature review Stay ahead of technology and innovation to improve the efficiency and quality of scientific literature search and review Collaborate with TA Safety and Case Management on process and system improvement opportunities What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is someone with these qualifications. Basic Qualifications: Doctorate degree / Master's degree / Bachelor's degree and 12 to 17 years of relevant experience Preferred Qualifications: Handling direct reports on a day-to-day basis and raising topics as needed to Director of PASR team Work within the Quality Management System framework including all applicable training and controlled documentation governing Pharmacovigilance processes Responsible for the growth and development of direct reports Ensure monthly review of performance metrics for the PASR process. Build and maintain good functional and multi-functional relationships globally Inspection Readiness: Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Support audit and inspection work, including but not limited to information requests and response QC. Extensive knowledge of global regulatory requirements for Pharmacovigilance Extensive knowledge of global PASR requirements Extensive knowledge of authoring PASRs Extensive people management experience Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment Understands and interprets data/information and its practical application Knowledge of scientific/technical writing and editing Excellent English written/oral communication, and strong time and project management skills strategic mentality, attention to detail, and the ability to work multi-functionally across multiple teams to ensure compliance, operational efficiency, and continuous improvement within Pharmacovigilance Operations. Demonstrate knowledge of global aspects of pharmacovigilance Strong knowledge of processes and global regulations for pharmacovigilance and periodic / aggregate reporting Ability to effectively handle challenging priorities and timelines Strong leadership skills, independence, networking and influencing skills Computer literate: knowledge of MS work, PowerPoint, Adobe Acrobat, MS Excel, SharePoint and Document Management Systems e.g. Veeva Vault Experience in use of AI and prompts would be useful What you can expect of us As we work to develop treatments that look after 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. 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. Please contact us to request accommodation.

India - Hyderabad JOB ID: R-218805 ADDITIONAL LOCATIONS: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: Jun. 27, 2025 CATEGORY: Safety 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 lie within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Group Purpose Integrated Signal Management group is responsible for the direction and strategy for safety signal detection and management, safety governance, and quality complaints trending and analytics. It drives policies, research, definition and implementation of innovation and best practices for safety data mining, signal detection planning, management, tracking, product complaints trending and analytics; risk management practices, benefit/risk assessment and safety communications while ensuring quality processes with proven metrics. Job Summary The Innovation Specialist will serve as a key strategic partner within the Signal Management and Post-Market Surveillance & Trending organization, focused on identifying, evaluating, and implementing emerging technologies and AI/ML-enabled analytical tools in collaboration with the ISM Data Science team. This role will bridge scientific, technical, and business functions to co-develop innovative surveillance capabilities that monitor the safety and quality of Amgen products. Key Activities Technology Scouting & Evaluation - Monitor and evaluate industry trends, emerging technologies, academic research, and vendor solutions related to AI/ML for post-market safety and product complaints surveillance. Maintain a landscape of external vendors offering signal detection, NLP, and data analytics solutions relevant to product surveillance. Collaboration & Innovation Development - Partner with the ISM Data Science team to assess feasibility, develop prototypes, and deploy AI/ML models for signal detection and augmentation of signal assessment Engage with stakeholders (e.g., TA Safety) to identify unmet needs and prioritize use cases. Facilitate workshops or ideation sessions to shape innovation roadmaps and pilot initiatives. Promote adoption of industry best practices and ensure compliance with regulatory guidance on AI/ML and surveillance in the context of combination products. Perform regulatory impact and risk analysis of proposed solutions Develop internal guidelines and documentation for use of advanced analytics in surveillance activities. Project Execution - Lead or support proof-of-concept and pilot initiatives for new surveillance technologies. Translate business needs into functional requirements for solution development. Track project progress, manage risks, and report findings to senior leadership. Knowledge and Skills Required Knowledge and Skills: Experience in post-market surveillance, pharmacovigilance, medical device vigilance, or related domain Knowledge of combination products and medical devices, including device safety monitoring regulations and standards Knowledge of software development concepts Experience with market scanning, vendor/product evaluation Knowledge of regulatory framework and guidance of principles for AI in the medicinal product lifecycle Preferred Knowledge and Skills: Demonstrated experience working with or evaluating AI/ML tools, safety analytics, natural language processing (NLP), or data mining. Strong project management, cross-functional collaboration, and communication skills Education & Experience 8-13 years of industry experience Experience with market scanning, vendor/product evaluation Experience working with AI/ML and/or automation tools Strong project management, cross-functional collaboration, and communication skills What you can expect from 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. 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 with 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.

India - Hyderabad JOB ID: R-219027 ADDITIONAL LOCATIONS: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: Jun. 27, 2025 CATEGORY: Safety 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 lie within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Group Purpose Group is accountable for global literature surveillance activities for all Amgen portfolio of products. Responsible for performing the weekly review of literature articles for signal detection and identification of safety reports. Job Summary This position is responsible for performing routine weekly reviews of literature articles retrieved from Embase, Medline, and BIOSIS, which are the bibliographic databases used for Amgen’s global literature surveillance. The review supports signal detection for all Amgen portfolio of products and identification of individual case safety reports (ICSRs) for marketed products. Key Responsibilities: Literature Management Process - Perform review of literature results retrieved and imported into literature citation management system on a weekly basis and determine if minimum criteria for ICSR is met for marketed products Perform review of literature results to determine if article contains new aggregate safety information in support of the periodic report and/or signal detection Determine whether full text article needs to be ordered and order them if further information is needed to confirm if the citation meets criteria for ICSR or for signal detection Flag articles containing new aggregate safety information for TA Safety to perform secondary review Request Local Safety Officer to provide English translation if the article is not in English Notify business partner of articles received, if applicable Perform retrospective quality checks on the quality of the literature review performed by team Support audits and inspections Collaborate with Case Management and TA Safety on process improvement initiatives Proactively proposes and system and process improvement ideas Provide training and onboarding to junior staff Perform Quality checks on literature reviews performed by other staff Periodic Reporting Process - May assist with quality control of periodic reporting activities as required. Extract list of citations for inclusion in periodic reports Key Activities Responsible for routine review of literature articles as part of the global literature surveillance process Assist with quality control of periodic reporting activities Support audits and inspections by extracting requested citations from literature citation management system Knowledge and Skills Knowledge of product profiles for products assignment Ability to identify literature articles containing ICSR criteria or aggregate safety findings supporting signal detection Ability to order full text articles where needed Ability to receive feedback from Case Management and TA Safety and optimize quality of literature review Demonstrate knowledge of global aspects of pharmacovigilance Strong knowledge of processes and global regulations for pharmacovigilance and literature surveillance Ability to effectively manage competing priorities and timelines Strong knowledge of literature citation management systems and platform used to configure search strategies Experience in use of AI and prompts would be useful CONTRIBUTION: Ensures Amgen remains in compliance and maintains high quality global literature review process Responsible for the timely completion of review of weekly literature results Education & Experience (Basic) 8-13 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting Knowledge of bibliographic databases and direct literature review experience (preferred) What you can expect from 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. 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 with 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: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs 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 world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. The incumbent will perform the regulatory operations tasks of bookmarking and hyper linking for granular components (documents) of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components. Collect, collate and evaluate the scientific data gathered as part of R & D. Advise on legal and scientific restraints and requirements. Ensure the organization`s products comply with current regulations. Example; Build regulatory submission strategy, author CMC documents, and health authority packages etc. What are we looking for? •Adaptable and flexible •Commitment to quality •Hands-on experience with trouble-shooting •Agility for quick learning •Ability to work well in a team 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 Bachelor of Pharmacy,Master of Pharmacy

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs 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 world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. The incumbent will perform the regulatory operations tasks of bookmarking and hyper linking for granular components (documents) of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components. Collect, collate and evaluate the scientific data gathered as part of R & D. Advise on legal and scientific restraints and requirements. Ensure the organization`s products comply with current regulations. Example; Build regulatory submission strategy, author CMC documents, and health authority packages etc. What are we looking for? •Adaptable and flexible •Commitment to quality •Hands-on experience with trouble-shooting •Agility for quick learning •Ability to work well in a team 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 Bachelor of Pharmacy,Master of Pharmacy

Skill required: Regulatory Services - Life Sciences Regulatory Operations Designation: LifeScience Regulatory Svs Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years Language - Ability: Portuguese - Intermediate 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 world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. The incumbent will perform the regulatory operations tasks of bookmarking and hyper linking for granular components (documents) of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components. Coordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for? s 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 Any Graduation

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 world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. 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 Associate Drug 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 Bachelor of Pharmacy,Master of Pharmacy

Core Responsibilities Develop, implement, and optimize patient support initiatives—covering enrollment, adherence, diagnostics and medication access across India Track program metrics (e.g., enrollment numbers, adherence rates, turnaround times), analyze trends, and generate actionable insights and communicate to pharma assigned companies. Build dashboards, reports, and governance tools for stakeholder visibility . Oversee training and coaching of field teams or counselors to ensure quality service delivery . Occasionally conduct field visits, patient counseling, and enrollment support Ensure adherence to SOPs, data privacy (e.g. IT Act of India, Indian Medical Council Guidelines), pharmacovigilance, and product complaint protocols—with all adverse events reported within stipulated timelines Develop and maintain process documentation for audits Education, Experience & Skills Bachelor’s degree (preferably in Life Sciences, Pharmacy, Medical, Public Health); advanced degree (MBA, etc.) preferred . 5–15 years in pharma or healthcare, with at least 2–5 years specifically managing PSP/PAP initiatives or patient programs in India Proficiency in MS Office (Excel, PowerPoint) knowledge of digital healthcare platforms Familiarity with BI tools like Tableau, Power BI (good to have) Data analysis skills (SQL, basic statistics) for metrics tracking and decision-making. (good to have) Strong project management, cross-functional collaboration, vendor management, and stakeholder communication . Analytical mindset, problem-solving orientation, and ability to work in compliance-driven environments Ability to translate patient needs into scalable program processes, govern complex stakeholder ecosystems, and navigate regulatory landscapes.