Skill required: Clinical Data Operations - Clinical Database Testing Designation: Clinical Data Svs Associate Qualifications: Masters in actuarial science Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world s leading biopharma companies bring their vision to life and enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Testing Team is dedicated to conduct through validation of all clinical trial database components ensuring that database meets quality standards while remaining cost effective. Their responsibilities include reviewing requirement specification, developing test scripts for carious testing types, performing data entry according to these scripts, executing test steps, documenting results and maintaining comprehensive records of all tested components in compliance with regulatory requirements.Design and test EDC databases, create and maintain User Acceptance Testing (UAT) procedures for EDC systems, including the creation of test plans, verification of requirements for databases, eCRFs, edit checks, extractions, and reports. What are we looking for Adaptable and flexibleAbility to perform under pressureProblem-solving skillsAbility to establish strong client relationshipAgility for quick learningCandidates who have completed Master s or Post graduate degree in Life Science domain (Biology, Genetics, Microbiology, Biochemistry, Biotechnology, and Ecology) in 2024 & 2025 (if all semester s results are available). Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Masters in actuarial science

Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Associate Qualifications: BE/BTech/Masters in actuarial science Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be part of our Life Sciences R&D division, which offers a comprehensive range of services across the life sciences sector. This includes Clinical Data Management, regulatory services, pharmacovigilance, and patient services solutions. Employees within this clinical capability will join one of our sub-offerings, such as Clinical Database build and Clinical Reporting. In these roles, you will support leading biopharma companies in realizing their vision, enhancing outcomes by focusing on the patient and integrating scientific expertise with unique insights into the patient experience.The Clinical Database Management team is committed to developing and maintaining databases for clinical trials, which includes creating Case Report Forms (CRFs) and developing Edit and Validation Checks using programming skills like C# and PL/SQL. They also support data integration from various external sources such as labs and Interactive Response Technology (IRT). The team ensures compliance with regulatory standards and guidelines, maintaining high levels of data quality and security. Additionally, they continuously seek to improve database processes and tools by leveraging the latest technologies and best practices to enhance efficiency and accuracyThe Clinical Reports Programming team is dedicated to developing and maintaining clinical reports for clinical trials. This involves utilizing PL/SQL, SQL, and Clinical SAS programming skills to create these reports. The team also integrates data from various sources such as EDC, Labs, and IRT. Ensuring that all reports comply with regulatory standards and guidelines is a crucial part of their work. They implement stringent quality assurance processes to uphold the highest levels of data integrity and report accuracy. Additionally, the team collaborates closely with clinical operations, biostatistics, and other departments to ensure the reports meet the needs of all stakeholders, facilitating informed decision-making based on accurate and timely data. What are we looking for Adaptable and flexibleAbility to perform under pressureProblem-solving skillsAbility to establish strong client relationshipAgility for quick learningCandidates who have completed B.Tech or B.E in Computer science in 2024 & 2025 (if all semester s results are available) Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification BE,BTech,Masters in actuarial science

Skill required: Clinical Data Operations - Clinical Database Testing Designation: Clinical Data Svs Associate Qualifications: Masters in actuarial science Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world s leading biopharma companies bring their vision to life and enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Testing Team is dedicated to conduct through validation of all clinical trial database components ensuring that database meets quality standards while remaining cost effective. Their responsibilities include reviewing requirement specification, developing test scripts for carious testing types, performing data entry according to these scripts, executing test steps, documenting results and maintaining comprehensive records of all tested components in compliance with regulatory requirements.Design and test EDC databases, create and maintain User Acceptance Testing (UAT) procedures for EDC systems, including the creation of test plans, verification of requirements for databases, eCRFs, edit checks, extractions, and reports. What are we looking for Candidates who have completed Master s or Post graduate degree in Life Science domain (Biology, Genetics, Microbiology, Biochemistry, Biotechnology, and Ecology) in 2024 & 2025 (if all semester s results are available).Adaptable and flexibleAbility to perform under pressureProblem-solving skillsAbility to establish strong client relationshipAgility for quick learningExperience with Clinical testing, Understanding of clinical Trials, Phases and clinical domain. Familiarity with clinical data management concepts and terminologies, Knowledge of regulatory guidelines such as GCP, ICH, 21 CRF Part 11 and GDRP. Experience in test script development and strong documentation skills for test cases, validation reports and audit trials. Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Masters in actuarial science

Skill required: Clinical Data Operations - Clinical Database Testing Designation: Clinical Data Svs Associate Qualifications: Masters in actuarial science Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world s leading biopharma companies bring their vision to life and enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Testing Team is dedicated to conduct through validation of all clinical trial database components ensuring that database meets quality standards while remaining cost effective. Their responsibilities include reviewing requirement specification, developing test scripts for carious testing types, performing data entry according to these scripts, executing test steps, documenting results and maintaining comprehensive records of all tested components in compliance with regulatory requirements.Design and test EDC databases, create and maintain User Acceptance Testing (UAT) procedures for EDC systems, including the creation of test plans, verification of requirements for databases, eCRFs, edit checks, extractions, and reports. What are we looking for Candidates who have completed Master s or Post graduate degree in Life Science domain (Biology, Genetics, Microbiology, Biochemistry, Biotechnology, and Ecology) in 2024 & 2025 (if all semester s results are available).Adaptable and flexible.Ability to perform under pressure.Problem-solving skills.Ability to establish strong client relationship.Agility for quick learning.Experience with Clinical testing, Understanding of clinical Trials, Phases and clinical domain. Familiarity with clinical data management concepts and terminologies, Knowledge of regulatory guidelines such as GCP, ICH, 21 CRF Part 11 and GDRP. Experience in test script development and strong documentation skills for test cases, validation reports and audit trials. Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Masters in actuarial science

Skill required: Marketing Operations - Medical Affairs Designation: Copywriting Senior Analyst Qualifications: Any Graduation Years of Experience: 5 to 8 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do Help balance increased marketing complexity and diminishing marketing resources. Drive marketing performance with deep functional and technical expertise, while accelerating time-to-market and operating efficiencies at scale through Data and Technology, Next Generation Content Services, Digital Marketing Services & Customer Engagement and Media Growth Services.Role requires Digital Marketing Ads & Promotion creation/designDesign, develop and deliver business solutions related to the medical affairs group of pharmaceutical companies, including thought leadership development, medical publications, education and information, medical grants, advisory boards and advocacy. What are we looking for Medical ReviewMedical MonitoringContent CreationProblem-solving skillsAgility for quick learningResults orientationCommitment to qualityWritten and verbal communicationClinical Data Review Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Skill required: Clinical Data Services - SDTM Mapping Designation: Clinical Data Svs Associate Qualifications: BE/Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.A standard structure for human clinical trial data tabulations and for nonclinical study data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA). What are we looking for Adaptable and flexibleAgility for quick learning Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification BE,Bachelor of Pharmacy,Master of Pharmacy

Skill required: Com.Bkg- Commercial Real Estate - Real Estate Due Diligence Designation: Banking Advisory Associate Qualifications: BCom/MCom/Master of Business Administration Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do We help clients address quality and productivity issues, keep pace with customer expectations, navigate regulatory and operational pressures and ensure business sustainability by transforming their banking operations into an agile, resilient operating model.The Corporate banking /Wholesale banking team is responsible for helping clients and organizations processes trade finance transactions by providing superior service delivery to trade customers whilst safeguarding the bank from risks associated with this business.Identify and assess, prevent and mitigate and account to provide reasonable measures to adapt before executing an agreement in relation to the real estate and immovable property. Valuation of commercial real estate using software like Argus, extracting key information from lease agreements (including amendments) and rent rolls. What are we looking for Agility for quick learningAbility to work well in a teamAbility to perform under pressureCommitment to qualityDetail orientation Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification BCom,MCom,Master of Business Administration

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

Multiple mailboxes handling, fluent in English (written/verbal communications), proactive for communications, Co-ordinating with clients as first contact point for routine communications, support during audits/inspections Basic knowledge of pharmacovigilance Well versed with MS outlook, Powerpoint, Excel. COMPETENCIES Accountability Communication Work Ethic Initiative Presentation / Communication skills Organizational Culture fit Flexibility/Planning & Organizing

Key Responsibilities: Collaborate with business stakeholders to understand data needs and reporting requirements specific to the pharmaceutical domain. Design and develop Power BI dashboards and reports that provide actionable insights. Connect to various data sources (e.g., clinical trials data, sales data, SAP, LIMS, etc.). Perform data cleansing, transformation, and modeling using Power Query and DAX. Work with cross-functional teams including data engineers, analysts, and domain experts. Ensure data accuracy, reliability, and performance optimization of BI solutions. Provide training and support to business users on Power BI reports and dashboards. Maintain documentation of reports, dashboards, data sources, and business logic. Ensure compliance with pharmaceutical regulations (e.g., FDA, GxP, 21 CFR Part 11) in all data-related activities. Required Qualifications: Bachelor s or Master s degree in Computer Science, Data Analytics, Life Sciences, or a related field. 5+ years of hands-on experience in Power BI development and business intelligence. Proven experience working within the pharmaceutical industry (R&D, manufacturing, supply chain, commercial, etc.). Strong knowledge of SQL, DAX, Power Query (M language), and data modeling. Experience working with data from clinical trials, regulatory systems, pharmacovigilance, or commercial pharma data is highly desirable. Familiarity with data governance and compliance frameworks relevant to the pharma industry. Strong analytical, problem-solving, and communication skills. Preferred Qualifications: Experience with Azure Data Services, Snowflake, or other cloud data platforms. Knowledge of statistical or clinical data standards (e.g., CDISC, SDTM). Power BI certification is a plus.

Overview of the role: • Responsible for preparation & review of clinical trial documents (Investigators Brochure, Protocol, ICD, CRF) and interpretation of clinical data and other complex information in a most acceptable quality document (Interim Report or Clinical Study Report) • Act as liaison between Scientific affairs team and Clinical Operations study team to provide highest quality Clinical trial documents. • Review and provide the scientific feedback on the essential documents related to conduct of clinical trial. • Write and review scientific abstracts, publication, related to clinical studies. Provide scientific inputs on Healthcare website, health magazine etc. Work closely with multidisciplinary group of experts to translate the study data and results into presentations, reports, regulatory documents, scientific journal manuscripts and abstracts for publication. • Should conduct comprehensive literature searches to enhance background understanding and evaluate and analyze the information. • Regular interaction with KOL in various therapeutic area and discussing on various factors for marketing, product positiong strategy • Interacting with the potential investigators prior to the protocol writing on the design and feasibility of conducting the study • Support in medical affairs activities related to Himalaya products. Provide support to marketing team for responding scientifically to the medical queries raised by the Doctors/ Field staff. Skills Requirement: • Data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills. Good knowledge of English grammar with a familiarity of writing clinical trial documents • Knowledge of global, regional, national and other document development guidelines • Comfort of searching the scientific matter available on open resources. • Ability to communicate scientific or medical information in a clear and concise manner • Should possess good training skills to conduct trainings at various platforms • In order to be effective in job, a Scientific Manager must be aware of current industry practices and regulatory requirements. Must keep abreast of current literature, emerging science, technological developments and medical trends. Role Requirements: • Degree in modern Medicine (MBBS/MD) with 0-3 years of experience OR Degree in alternative medicine (BAMS/ BHMS) OR PhD (Pharmacology) with Medical writing (related to Clinical Trials Document & Publications) experience of at-least 5 years at sponsor or CRO Company is must. • Hands on experience in literature search, targeted literature review, preparation of scientific document, disease or drug related literature on the basis of data available from publications, clinical trials. • Experience in preparation of scientific abstracts, publication would be preferred • Must have thorough knowledge of clinical trial concepts including ICH-GCP, CFR and applicable regulatory guidelines (DCGI, USFDA, MHRA)

Job description: Job Description Role Purpose The purpose of the role is to provide effective technical support to the process and actively resolve client issues directly or through timely escalation to meet process SLAs ͏ Do Support process by managing transactions as per required quality standards Fielding all incoming help requests from clients via telephone and/or emails in a courteous manner Document all pertinent end user identification information, including name, department, contact information and nature of problem or issue Update own availability in the RAVE system to ensure productivity of the process Record, track, and document all queries received, problem-solving steps taken and total successful and unsuccessful resolutions Follow standard processes and procedures to resolve all client queries Resolve client queries as per the SLA’s defined in the contract Access and maintain internal knowledge bases, resources and frequently asked questions to aid in and provide effective problem resolution to clients Identify and learn appropriate product details to facilitate better client interaction and troubleshooting Document and analyze call logs to spot most occurring trends to prevent future problems Maintain and update self-help documents for customers to speed up resolution time Identify red flags and escalate serious client issues to Team leader in cases of untimely resolution Ensure all product information and disclosures are given to clients before and after the call/email requests Avoids legal challenges by complying with service agreements ͏ Deliver excellent customer service through effective diagnosis and troubleshooting of client queries Provide product support and resolution to clients by performing a question diagnosis while guiding users through step-by-step solutions Assist clients with navigating around product menus and facilitate better understanding of product features Troubleshoot all client queries in a user-friendly, courteous and professional manner Maintain logs and records of all customer queries as per the standard procedures and guidelines Accurately process and record all incoming call and email using the designated tracking software Offer alternative solutions to clients (where appropriate) with the objective of retaining customers’ and clients’ business Organize ideas and effectively communicate oral messages appropriate to listeners and situations Follow up and make scheduled call backs to customers to record feedback and ensure compliance to contract /SLAs ͏ Build capability to ensure operational excellence and maintain superior customer service levels of the existing account/client Undertake product trainings to stay current with product features, changes and updates Enroll in product specific and any other trainings per client requirements/recommendations Partner with team leaders to brainstorm and identify training themes and learning issues to better serve the client Update job knowledge by participating in self learning opportunities and maintaining personal networks ͏ Deliver No Performance Parameter Measure 1ProcessNo. of cases resolved per day, compliance to process and quality standards, meeting process level SLAs, Pulse score, Customer feedback2Self- ManagementProductivity, efficiency, absenteeism, Training Hours, No of technical training completed Mandatory Skills: Pharmacovigilance & Drug Safety(Pharma) . Reinvent your world. We are building a modern Wipro. We are an end-to-end digital transformation partner with the boldest ambitions. To realize them, we need people inspired by reinvention. Of yourself, your career, and your skills. We want to see the constant evolution of our business and our industry. It has always been in our DNA - as the world around us changes, so do we. Join a business powered by purpose and a place that empowers you to design your own reinvention. Come to Wipro. Realize your ambitions. Applications from people with disabilities are explicitly welcome. Show more Show less

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

Projects and/or Vendor Management: Manage assigned vendor training curriculum content, ensure applicable training job roles are assigned/maintained and work with vendor counterparts to monitor contracted resource training class completions to ensure sustainable 100% due date compliance Support Projects and Vendor Management Leads (PVMLs) for procuring purchase orders for engagements, review/reconciliation of project/vendor invoices Liaise with Business Technology (BT) to setup and troubleshoot vendor connectivity to the Pfizer network and applications Support PVMLs with project/resource identity management (i. e. onboarding, offboarding and system access privileges etc. ) Identify and lead issues to resolution with vendor counterparts and escalate as applicable through respective PVMLs Distribute business communications to project/vendor contacts per PVML request Support the Projects and Vendor Management Team Lead (PVM TL) with the review and continuous improvement of the WWS vendor management program Manage project and vendor collaboration/document repositories (e. g. folder structures, security access groups, site/folder permissions etc. ) Support PVMLs in their execution of project and/or vendor management responsibilities as situations dictate Business Information Collection and Analysis: Support the PVM TL with portfolio/project/vendor performance status requirements and collection/dissemination of reports Perform summary business case analysis to support development of sourcing strategies Manage the collection of project/vendor spend information, analyze spend against budget/forecast commitments, alert respective PVMLs of variances etc. and communicate aggregate project/vendor forecast/spend information to Finance Maintain data standards used to obtain and manage consistent vendor management compliance Coordinate the collection, maintenance, analysis and presentation of local vendor information against global data standards Develop and maintain technology data standards to ensure the accurate and consistent collection, measurement and presentation of projects and/or vendor management information Qualifications (i. e. , preferred education, experience, attributes) Bachelor s degree in medicine, life sciences or business required. Lean Six Sigma credentials (e. g. Green Belt) preferred Experience: At least 5 years business experience with an emphasis on the analysis and presentation of operational data to identify trends, application and use of data standards, and/or the development and continuous improvement of business processes Experience in a project management office (PMO) and/or supporting vendor management activities preferred Excellent working knowledge of Microsoft Office products Working knowledge of pharmacovigilance concepts preferred Experience working with collaboration tools (e. g. SharePoint) Experience with configuration management of technology systems to ensure the correct data gathering/aggregation/analysis etc. Work Location Assignment: Hybrid Quality Assurance and Control #LI-PFE

Locations – Guwahati, Jaipur, Lucknow & Indore Department – Medical Affairs Team Are you an experienced medical professional and passionate about Medical Affairs? Does being part of a growing, yet dynamic environment excite you? Are you adept in implementing the medical affairs strategy in the country? Apply now with your latest profile and you may be our new Regional Medical Advisor. The Position As a Regional Medical Advisor, you will contribute actively to medico-marketing activities in the business area/portfolio and support in implementation of the Medical Affairs strategy in the country. You will be responsible for: Executing the Indian medical strategy into local activities in your designated region Building, maintaining, and nurturing the excellent scientific relationship with all the key influencers and stakeholders Training and educational activities for Physicians and other Health Care Professionals (HCPs) working with diabetes and obesity Medical support to brand team You will also be responsible for: To assist the marketing and sales team in sharpening and positioning product and promotional strategies. Foresee the challenges as well as changing market dynamics and make timely corrective and preventive actions. You will stay updated on scientific knowledge by actively participating in scientific meetings, gathering clinical insights/needs/feedback from key opinion leaders, and communicating with internal stakeholders. Responsible for educating and training the field and marketing personnel and other relevant stakeholders regarding all aspects of disease, product, and therapy relevant to promotional strategy. You will build a strong advocacy of Novo Nordisk’s portfolio with key external stakeholders through ongoing/robust scientific interactions. Qualifications MBBS/ MD in Pharmacology from a reputed institution. MDS/BDS with a minimum of 2 years of clinical work experience (allied experience like Pharmacovigilance, Medical Affairs, clinical research, medical writing, etc.) You shall have strong scientific knowledge and interest in diabetes and obesity including both the therapy area and the products, good collaboration with internal and external stakeholders as well as good communication and negotiation. Strong analytical capabilities, with demonstrated experience in analyzing complex situations. Skills for planning, execution, and follow-up are required, with a creative and innovative attitude that will enable you to drive initiatives with operational excellence and strive towards working with both operational as well as more judicious tasks. About The Department The Clinical, Medical, and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From HCP interactions and developing and implementing regulatory strategies with the health authorities to providing medical education and collecting data to support our products, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for living. Working at Novo Nordisk Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we're working toward something bigger than ourselves, and it's a collective effort. Join us! Together, we go further. Together, we're life changing. Contact To submit your application, please upload your CV and motivational letter online (click on Apply and follow the instructions). Deadline 30/0April/2025 Disclaimer It has been brought to our attention that there have recently been instances of fraudulent job offers, purporting to be from Novo Nordisk and/or its affiliate companies. The individuals or organizations sending these false employment offers may pose as a Novo Nordisk recruiter or representative and request personal information, purchasing of equipment or funds to further the recruitment process or offer paid trainings. Be advised that Novo Nordisk does not extend unsolicited employment offers. Furthermore, Novo Nordisk does not charge prospective employees with fees or make requests for funding as a part of the recruitment process. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing. Show more Show less

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

Job Title: International Business Manager – Middle East Location: Delhi Reporting to: Global Head of International Business About the client: PSS has been mandated to hire an International Business Manager - Middle East for a reputed and fast-growing pharmaceutical formulations company based in North India with a diverse portfolio of over 1,000 products (tablets, capsules, injections, eye drops, nose drops, and others). Job Purpose Build and grow a business in the Middle East markets Build strong commercial relationships in the assigned territory. Build business and relationships in the private and institutional segments of the region. Key Responsibilities Market Expansion Drive market entry, registration, and sales strategy across all GCC countries Analyze market potential, demand trends, pricing structures, and tender opportunities. Regulatory Affairs & Approvals Manage end-to-end product registration processes with local health authorities in Saudi Arabia, UAE, Qatar, etc. Coordinate with internal regulatory teams and local agents to ensure timely dossier submission, query handling, and MOH approvals. Distributor & Partner Management Identify, evaluate, appoint, and manage local distributors and agents. Monitor partner performance and support them in institutional tender participation, sales, and product positioning. Tender & Institutional Business Actively track and participate in government tenders, hospital listings, and health ministry procurements Prepare required documentation and liaise with partners for tender submission and compliance. Sales & Forecasting Define sales targets for each market and ensure achievement through structured planning and performance monitoring. Maintain pricing discipline and oversee logistics coordination with the supply chain. Trade Engagement & Marketing Participate in key regional pharma events like DUPHAT, Arab Health, and local distributor conferences. Guide adaptation of product packaging, marketing collaterals, and promotional material to suit regulatory and cultural preferences. Compliance & Documentation Ensure adherence to Gulf regulatory, pharmacovigilance, and anti-bribery policies. Maintain meticulous records of MOH communication, regulatory submissions, approvals, and product lifecycle status. Educational Qualifications And Experience BPharm/ BSc/ BE, MBA (preferred). Minimum 7–10 years of international pharmaceutical business development experience, specifically in Middle east markets. Proven success in regulatory submissions, market access, and distributor partnerships in the Gulf. Familiarity with MOH online portals (e.g., SFDA, Tatmeen, MOHAP). Excellent negotiation and cross-cultural communication skills. Willingness to travel internationally to assigned territories Show more Show less

India - Hyderabad JOB ID: R-206159 LOCATION: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: Feb. 12, 2025 CATEGORY: Engineering Associate IS Engineer – Tech Enablement Team Job Posting Title : Associate IS Engineer Workday Job Profile : Associate IS Engineer Department Name: Digital, Technology & Innovation Role GCF: 3 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. ABOUT THE ROLE Role Description: As a Sr Associate IS Engineer, 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, and facilitating continuous improvement in both technical skills and user experience. Roles & Responsibilities: Work with partners to identify and prioritize system enhancements and new functionalities to meet evolving business needs Lead the day-to-day operations and maintenance of Pharmacovigilance (PV) systems. Overall accountability of technical implementation aspects of projects including planning, architecture, design, development, and testing to follow IS Change Control and GxP validation process. Provide support and consultation to clients or project teams to identify requirements and assist with application configurations and deployments. Monitor operational and performance statistics for managed systems to ensure reliability and availability. Oversee production change control schedule and participates in change control processes. Stay updated on industry trends, emerging trends and standard processes for PV systems. Maintain knowledge of trends in application development frameworks and related new technologies to provide, recommend, and deliver standard methodology solutions. Basic Qualifications and Experience: Master’s degree with 1 - 2 years of experience in Computer Science,Software Development, IT or related field OR Bachelor’s degree with 2 - 4 years of experience in Computer Science, Software Development, IT or related field OR Diploma with 5 - 8 years of experience in Computer Science, Software Development,IT or related field Functional Skills: Must-Have Skills : Experienced in database programming languages, data modelling concepts, including Oracle SQL and PL/SQL. Excellent problem-solving skills. Collaborative spirit and effective communication skills to seamlessly work in a cross-functional team. Hands-on experience with the ITIL framework. Good-to-Have Skills: Experience with API integrations such as MuleSoft, Data Bricks platforms Knowledge of Artificial Intelligence (AI), Robotic Process Automation (RPA), Machine Learning (ML), Natural Language Processing (NLP) and Natural Language Generation (NLG) automation technologies with building business requirements. Experienced in managing GxP systems and implementing GxP projects Extensive experience with Software Development Lifecycle (SDLC). Ability to explain technical concepts to non-technical clients Professional Certifications: SAFe® for Teams certification (preferred) Soft Skills: Excellent analytical and problem-solving 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 Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills Ability to deal with ambiguity andprioritize 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-213521 LOCATION: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: Apr. 25, 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. ABOUT THE ROLE Role Description: As a Specialist IS Bus Sys Analyst, you will join a collaborative team implementing and supporting the next generation of safety platforms and supporting technologies. In this role, you will both engage with the business users and functional SMEs for the implementation/improvement of the signal solution and technologies. This role focuses on delivering data-driven solutions, automating processes, and addresses the ongoing issues with Signal and Risk management systems. Roles & Responsibilities: Work with partners to identify and prioritize system enhancements and new functionalities to meet evolving business needs Responsible for defining and implementing a project and technical road maps that align with the strategy Find 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 Work closely with the delivery and platform teams to ensure that the applications are aligned with approved architectural and development guidelines Identify data patterns to support informed decision making. Collect analyze, and interpret data to identify trends, insights, and areas of improvement. Keeps updated on industry trends, emerging trends and standard processes for pharmacovigilance systems Leads and contributes to business case development, workshops, and RFP’s 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 Basic Qualifications and Experience: 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 Must-Have Skills: 3+ years of experience COTS Pharmacovigilance Platforms (for example Argus) is a plus or other safety database. Extensive expertise in SDLC, including requirements, design, testing, data analysis, change control Experienced in Agile project methodologies and working in Product Teams by using JIRA Experience or demonstrable understanding of Computer Systems Validation including FDA 21 CFR Part 11, GxP Compliance, and change control Strong communications skills in writing, speaking, communicating and time management skills Has high learning agility, problem solving and analytical thinking Has requirements gathering and process improvement experience Good-to-Have Skills: Ability to work in a fast-paced and dynamic environment Able to communicate technical or complex subject matters in business terms Outstanding written and verbal communication skills, and ability to explain technical concepts to non-technical clients Experience with Safety Signal and Risk Management platforms is a plus Experienced in database programming languages, data modelling concepts, including Oracle SQL and PL/SQL Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Excellent analytical and troubleshooting skills Excellent leadership and strategic 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-205833 LOCATION: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: Feb. 04, 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. Study Liaison Manager What you will do Let’s do this. Let’s change the world. In this vital role you will Accountable for the development of Global Patient Safety (GPS) strategy for safety-related organized data collection in Amgen clinical trials in compliance with global regulatory requirements and Amgen compliance policies and standards. Accountable for the review, approval, and execution of GPS safety data collection strategy across clinical programs (e.g. interventional, observational research, non-Amgen sponsored clinical research, post-trial access, expanded access, etc.). Responsible for participating in cross-functional activities to ensure and promote compliance with pharmacovigilance data collection standards and operational consistency across clinical programs for all Amgen products. Job Summary The Manager works on projects and process that ensures the strategies of the department are driven into the safety related organized data collection activities in Amgen clinical activities to ensure Amgen remains aligned with global safety legislation and requirements Provides input to Clinical teams on the needs and timelines of safety related organized data collection to ensure these needs are met and incorporated into Amgen studies activities/programs that may generate reportable safety event information Accountable as liaison between clinical trial and Global Patient Safety to ensure capture of all reportable safety event data generated by such programs and activities Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Key Activities Participates in the creation and dissemination of appropriate safety reporting language in clinical trial key documents, such as study protocols, contracts, safety management plans, and investigative site study guidance documents Supports the department by being a liaison between clinical trial and Global Patient Safety to ensure capture of all reportable safety event data generated by such programs Support activities to ensure GPS input to clinical study initiatives Accountable for vendor oversight of clinical reconciliation activities to ensure reporting of all reportable safety event data within team’s remit Actively participates in cross functional projects that develop and support strong cross-functional relationships and communication Develops and communicates plans/objectives to others as needed Maintains knowledge of adverse event reporting process and safety system and contribute to the development, improvement and standardization of new processes and methods Contributes to projects which involve the implementation of new processes and methods within and across Global Patient Safety Maintain functional area standard operating procedures and contribute to R&D Standards documents as applicable Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Provide input to GPS contracting groups globally Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility Performs other duties related to the position as vital as defined in Standard Operating Procedures or as requested by their supervisor. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Doctorate degree and 2 years of directly related experience OR Master’s degree and 4 years of directly related experience OR Bachelor’s degree and 6 years of directly related experience OR Associate’s degree and 8 years of directly related experience Or High school diploma / GED and 10 years of directly related experience AND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications: Able to effectively represent ideas both verbally and in writing Sound knowledge of the global safety environment, regulations, and guidance Project and/or Process Management experience & knowledge Sound understanding of safety data capture, representation, and interpretation Sound knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery Able to apply multi-disciplinary knowledge and understanding to effectively collaborate and negotiate within function and cross-functionally Able to organize, plan and prioritize workload for the function What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

India - Hyderabad JOB ID: R-206033 LOCATION: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: Feb. 04, 2025 CATEGORY: Research 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. Safety Sciences Lead What you will do Group Purpose The Global Safety Therapeutic Areas serve as the safety experts for all Amgen products globally and are accountable for the robust safety strategy and deliverables for each Amgen product. The group collaboratively drive excellence in patient safety by leading signal detection, management activities, and risk management practices, including Risk Evaluation and Mitigation Strategies (REMS). Through the definition and implementation of innovative policies, research initiatives, and best practices in safety science, the teams ensure comprehensive benefit-risk assessments, effective safety communications, and adherence to quality processes supported by measurable metrics. Leaders in the therapeutic area safety teams are accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance with worldwide regulations. Let’s do this. Let’s change the world. In this vital role you will oversee all signal management activities and staff in the Safety Sciences Team at the India site, working closely with the global teams while ensuring compliance with global regulations and company standards. This role requires a strong leadership attribute with a deep understanding of drug safety and pharmacovigilance, signal detection and management, safety data analyses, risk management and people leadership/ management, along with experience in innovation and technology. This staff member will provide leadership to the Safety Sciences Team, consisting of staff based in India working across multiple therapeutic areas and signal management, while reporting into the GPS AIN Lead. Key Activities Provide direction, strategy and leadership for signal detection and management activities at the India site Provide managerial leadership to the safety sciences team allowing appropriate prioritization of resources to achieve GPS goals. Regular communication with the global team to discuss product and/or process issues. Recruit and retain talented safety professionals. Provide coaching, mentoring, and development of staff Ensure staff are compliant with Amgen corporate and departmental training Disseminate relevant information to teams as appropriate Ensures smooth and collaborative interactions with all other Safety groups Provides relevant input on technical processes in the department and contributes to continuous improvement initiatives across GPS Accountable for delivery against goals assigned to group Participate in budget and headcount planning Establish effective, collaborative interfaces with partners outside of GPS e.g. tech to ensure GPS needs are being met with respect to signal management Lead or contribute to cross-functional initiatives aimed to improve pharmacovigilance capabilities related to signal management What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Medical degree and 6 years of directly related experience in global Pharmacovigilance for a biotechnology or pharmaceutical company in the clinical trial and post marketing environments. Minimum of 6 years of experience in global Pharmacovigilance for a biotechnology or pharmaceutical company in the clinical trial and post marketing environments. A minimum of 3 years of functional management experience overseeing PV staff A thorough understanding of the global PV regulatory environment with working knowledge of EU and US regulations, ICH guidelines, and GCP, a working understanding of drug safety databases, effective project management skills, a demonstrated ability to provide critical and timely insight, and analytical problem-solving skills with a broad perspective Leadership skills and the ability to oversee multiple projects simultaneously Able to successfully manage workload to timelines Able to respond and provide astute advice quickly to difficult scenarios or in response to tough questions Familiarity with basic project management tools Ability to negotiate a strategic position after taking feedback from multiple sources Shift timings 12 PM to 9 PM IST What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

India - Hyderabad JOB ID: R-206989 LOCATION: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: Feb. 03, 2025 CATEGORY: Quality 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. Case Management QA Vendor Sr Associate What you will do Support interactions with business partners (license partners) and vendors for all case intake and processing activities. Vendor oversight of all case intake and processing activities and case quality including analysis and reporting of trends in quality measures. Ensure vendor compliance with approved processes and training requirements. Submission of all individual case safety reports to FDA/EMA, business partners (license partners), and vendors. Act as US/EU local safety office and FDA/EMA point of contact for safety reporting. Provide audit & external inspection support. Assist in assuring quality of Individual Case Safety Report (ICSR) processing globally for clinical trial and post-market cases processed by vendors Ensure Vendors deliver high quality cases through metric management meet all worldwide regulatory authority requirements Provide vendors with resources and training to perform their role Analysis and communication of case Quality Control results Responsible for escalation of case related issues from vendor(s) Providing audit/inspection support for case management related activities, including liaising with vendors to provide support as applicable Undertaking activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the PV System Master File and maintain a state of inspection readiness May assist with Periodic Aggregate Safety Reports (PASR) processes and associated metrics throughout the product lifecycle as applicable Other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by their supervisor · Work within the Quality Management System framework including all applicable training and controlled documentation governing Pharmacovigilance processes Ensure vendor case processing timelines for AE intake, triage and submission are met Perform retrospective quality assurance of vendor processed cases Day-to-day vendor management issues Interact with other local safety offices as applicable Support on-boarding and off-boarding of vendor staff Attend management meetings with vendors Support analysis of QC trends Support generating, communicating, and archiving of reports of QC findings Support audits of CAPAs and other actions/recommendations for ICSR quality related measures Perform case review as required Generate and distribute performance metrics (retro QA / Case correction) Support analysis of QC trends including actions/recommendations What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Master’s degree and 3 years of directly related experience (OR) Bachelor’s degree and 5 years of directly related experience (OR) Associate’s degree and 10 years of directly related experience (OR) High school diploma / GED and 12 years of directly related experience (AND) Previous experience directly managing teams, projects, programs or directing the allocation of resources Preferred Skills: Understanding of global regulatory requirements for pharmacovigilance Proficiency in safety case processing Expertise in all aspects of case intake and processing in multiple global safety databases Experience in supporting inspections or internal audits Communication skills and attention to detail Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

India - Hyderabad JOB ID: R-206995 LOCATION: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: Feb. 03, 2025 CATEGORY: Quality 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. Case Management QA Vendor Associate What you will do Support interactions with business partners (license partners) and vendors for all case intake and processing activities. Vendor oversight of all case intake and processing activities and case quality including analysis and reporting of trends in quality measures. Ensure vendor compliance with approved processes and training requirements. Submission of all individual case safety reports to FDA/EMA, business partners (license partners), and vendors. Act as US/EU local safety office and FDA/EMA point of contact for safety reporting. Provide audit & external inspection support. Assist in assuring quality of Individual Case Safety Report (ICSR) processing globally for clinical trial and post-market cases processed by vendors Ensure Vendors deliver high quality cases through metric management meet all worldwide regulatory authority requirements Provide vendors with resources and training to perform their role Analysis and communication of case Quality Control results Responsible for escalation of case related issues from vendor(s) Providing audit/inspection support for case management related activities, including liaising with vendors to provide support as applicable Undertaking activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the PV System Master File and maintain a state of inspection readiness May assist with Periodic Aggregate Safety Reports (PASR) processes and associated metrics throughout the product lifecycle as applicable Other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by their supervisor · Work within the Quality Management System framework including all applicable training and controlled documentation governing Pharmacovigilance processes Ensure vendor case processing timelines for AE intake, triage and submission are met Perform retrospective quality assurance of vendor processed cases Day-to-day vendor management issues Interact with other local safety offices as applicable Support on-boarding and off-boarding of vendor staff Attend management meetings with vendors Support analysis of QC trends Support generating, communicating, and archiving of reports of QC findings Support audits of CAPAs and other actions/recommendations for ICSR quality related measures Perform case review as required Generate and distribute performance metrics (retro QA / Case correction) Support analysis of QC trends including actions/recommendations What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Bachelor’s degree and 3 years of directly related experience (OR) Associate’s degree and 5 years of directly related experience (OR) High school diploma / GED and 7 years of directly related experience (AND) Previous experience directly managing teams, projects, programs or directing the allocation of resources Preferred Skills: Understanding of global regulatory requirements for pharmacovigilance Proficiency in safety case processing Expertise in all aspects of case intake and processing in multiple global safety databases Experience in supporting inspections or internal audits Communication skills and attention to detail Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

India - Hyderabad JOB ID: R-205446 LOCATION: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: Feb. 02, 2025 CATEGORY: Information Systems Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you are part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. What you will do Let’s do this. Let’s change the world. In this vital role you will be part of the Global Patient Safety organization this team implements Intake and Triage of product complaints (PCs), adverse events (AEs) and other safety findings (OSFs). Their focus includes assuring compliant processes and systems remain fully compliant through the pharmacovigilance and quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement. Job Summary The PC Triage and Intake Associate is responsible for global triage of Product Complaints and ensure proper Adverse Events and/or Other Safety Findings were captured. Ensure to capture the patient outcome because of the reported event. This position ensures compliance with global and local procedural documents and local implementation of Amgen Corporate, Patient Safety, and Quality objectives, policies, processes, and procedures. Key Activities Work within the Quality Management System framework including all applicable training and controlled documentation governing Pharmacovigilance processes. Triage of initial data entry (book-in) of new PC, AE and OSF cases is complete. Performs the initial book-in activities and appends additional information or documents to the case as they are received in the global intake system. Ensures compliance with global and local procedural documents and local implementation of Amgen Corporate, Patient Safety, and Quality objectives, policies, processes and procedures. Supports performance emphasized culture. Ensures quality of PC, AE and OSF records. Implements Standard Operating Procedure requirements for the triage process. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Education & Experience (Basic) Master’s degree and 3 years of Drug Safety or Life Sciences experience OR Bachelor’s degree and 5 years of Drug Safety or Life Sciences experience Education & Experience (Preferred) Pharmacovigilance, or Quality experience in biotech, pharmaceutical or medical device industry Bachelor’s Degree in a health-care subject area or scientific field Previous experience with a corporate intake system or safety database Ability to successfully manage workload to strict timelines Familiarity with basic project management tools Demonstrated ability to consistently deliver on-time, and high-quality results Ability to operate in a matrixed or team environment Understanding of the applicable global regulatory requirements (Good Manufacturing Practices, Good Pharmacovigilance Practices) What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Projects and/or Vendor Management: Manage assigned vendor training curriculum content, ensure applicable training job roles are assigned/maintained and work with vendor counterparts to monitor contracted resource training class completions to ensure sustainable 100% due date compliance Support Projects and Vendor Management Leads (PVMLs) for procuring purchase orders for engagements, review/reconciliation of project/vendor invoices Liaise with Business Technology (BT) to setup and troubleshoot vendor connectivity to the Pfizer network and applications Support PVMLs with project/resource identity management (i.e. onboarding, offboarding and system access privileges etc.) Identify and lead issues to resolution with vendor counterparts and escalate as applicable through respective PVMLs Distribute business communications to project/vendor contacts per PVML request Support the Projects and Vendor Management Team Lead (PVM TL) with the review and continuous improvement of the WWS vendor management program Manage project and vendor collaboration/document repositories (e.g. folder structures, security access groups, site/folder permissions etc.) Support PVMLs in their execution of project and/or vendor management responsibilities as situations dictate Business Information Collection and Analysis: Support the PVM TL with portfolio/project/vendor performance status requirements and collection/dissemination of reports Perform summary business case analysis to support development of sourcing strategies Manage the collection of project/vendor spend information, analyze spend against budget/forecast commitments, alert respective PVMLs of variances etc. and communicate aggregate project/vendor forecast/spend information to Finance Maintain data standards used to obtain and manage consistent vendor management compliance Coordinate the collection, maintenance, analysis and presentation of local vendor information against global data standards Develop and maintain technology data standards to ensure the accurate and consistent collection, measurement and presentation of projects and/or vendor management information Qualifications (i.e., preferred education, experience, attributes) Bachelor’s degree in medicine, life sciences or business required. Lean Six Sigma credentials (e.g. Green Belt) preferred Experience: At least 5 years business experience with an emphasis on the analysis and presentation of operational data to identify trends, application and use of data standards, and/or the development and continuous improvement of business processes Experience in a project management office (PMO) and/or supporting vendor management activities preferred Excellent working knowledge of Microsoft Office products Working knowledge of pharmacovigilance concepts preferred Experience working with collaboration tools (e.g. SharePoint) Experience with configuration management of technology systems to ensure the correct data gathering/aggregation/analysis etc. Work Location Assignment: Hybrid Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. Quality Assurance and Control #LI-PFE