1738 Pharmacovigilance Jobs - Page 9

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice. Sr Medical Advisor - Oncology POSITION PURPOSE: The position is responsible for the medical and scientific support, including technical advice to the Business Units and Pharmacovigilance/ Medical Information and Clinical Research teams in their assigned therapeutic areas. The position holder oversees the Medical Affairs function in India in their assigned therapeutic/product areas and cooperates with Regional Medical Affairs functions and relevant Global Medical Affairs functions. This position holder is responsible for ensuring that marketing and sales functions have appropriate medical scientific support and training (the latter in co-operation with the Training department). To enable this support, product and development project information is to be kept up to date based on internal publications and communication with regional and global Medical Affairs functions as well as based on review of pertinent scientific publications. In addition to this, the position holder is responsible for the review process of promotional materials in the respective area according to the global SOP and local laws and compliance. The tasks also include monitoring of medical marketing activities of competitors locally and worldwide and close interaction especially with regional medical affairs functions. The position holder will further support regulatory, PV/MI and CR teams in medical scientific questions and prepare and give internal (mainly marketing and sales functions) and possibly external presentations (local advisory board meetings, launch symposia and others) to enhance the medical knowledge of development projects and marketed products. This also includes interaction and relationship-building with TLs. YOUR TASKS AND RESPONSIBILITIES : Medical Marketing Provide timely and appropriate medical review of all promotional material as well as challenging promotional activities of competitors where appropriate. Support BUs in transforming medical data into marketing strategy Work closely with other members of the medical team (especially the MSLs) to support the business Build up good relationships with customers and TLs Build strong relationships with internal customers (marketing and sales) and with regional / global Medical Affairs Provide development project and product training internally to marketing and sales functions and externally to doctors Support and educate internal customers in compliance with the Country’s Code of Conduct Provide a comprehensive and proactive Medical service that encompasses, as appropriate, including Medical Support, Medical Information and Pharmacovigilance As Senior Medical Advisor, is responsible for overall medical inputs to Integrated Brand Plans of assigned therapeutic areas, provision of scientific expertise, review of promotional materials, thought leader management, speaker development and training. Takes responsibility for study development programmes of the Business units within portfolio (included local studies NIS, IIR). Identifies, initiates and completes agreed study development activities in a timely manner, be IIR responsible of local IIR. Takes responsibility for all study development activities that they are running in accordance with all applicable external and internal regulations and guidelines. Play a role as local medical expert for Global Clinical Development by providing inputs for medical queries related to trials; participate in site feasibility. Respond to all external scientific and medical queries from physicians, regulatory authorities and public alike in an accurate, transparent and convincing manner in order to position Bayer as a credible, trustworthy and professional leader in the industry. Support the Local Safety Issue and Crisis Management in collaboration with the Headquarters. Support the local Safety Management Team. Reviews all local patient support programs and other undertakings of the local organization with potential consequences on PV obligations (e.g. Market Research, Active-Online-Listening programs) to ensure Pharmacovigilance principles are applied in the interaction with patients. Develops, maintains and strengthens strategic partnership with relevant TLs, societies and associations. Act as medical contact for TL and external Medical experts. In collaboration with local marketing to develop, conduct Advisory Board meetings, Congress and Symposia. WHO YOU ARE: Certified Medical Doctor from a recognized Medical University (MBBS and MD in Pharmacology). More than three (3) years’ of experience as Medical Advisor in Oncology or Hematology Have in depth Disease Area expertise and technical knowledge in the assigned therapeutic areas. For the role is desirable: Experience in driving and managing the medical strategy for Specialty therapy area like Oncology or Hematology. Clinical trial management experience, and be able to interact authoritatively with key stakeholders and investigators. Excellent presentation and teaching skills and to represent the company in a professional manner at medical, scientific and public events. Independent, self-driven, pro-active, collaborative and customer focused. Ability to form relationships quickly and have demonstrable persuasive abilities Highly effective communicator both orally and in writing; can get ideas across one-on-in, in group settings as well as in presentations Highly organized with attention to detail Strong team player and know how to collaborate and engage many stakeholders across a large organization Solid negotiation and decision-making skills Good analytical and numerical abilities Adaptability Innovative Strategic thinking Results-oriented attitude Experience in working with MS office in a Windows environment Willing to travel Ever feel burnt out by bureaucracy? Us too. That's why we're changing the way we work- for higher productivity, faster innovation, and better results. We call it Dynamic Shared Ownership (DSO). Learn more about what DSO will mean for you in your new role here https://www.bayer.com/enfstrategyfstrategy Bayer does not charge any fees whatsoever for recruitment process. Please do not entertain such demand for payment by any individuals / entities in connection with recruitment with any Bayer Group entity(ies) worldwide under any pretext. Please don’t rely upon any unsolicited email from email addresses not ending with domain name “bayer.com” or job advertisements referring you to an email address that does not end with “bayer.com”. For checking the authenticity of such emails or advertisement you may approach us at HROP_INDIA@BAYER.COM. YOUR APPLICATION Bayer is an equal opportunity employer that strongly values fairness and respect at work. We welcome applications from all individuals, regardless of race, religion, gender, age, physical characteristics, disability, sexual orientation etc. We are committed to treating all applicants fairly and avoiding discrimination. Location: India : Maharashtra : Mumbai Division: Pharmaceuticals Reference Code: 850670 Contact Us + 022-25311234

As a Product Manager at RxLogix, your role will involve defining and managing use cases, business requirements, functional requirements, and acceptance criteria for RxLogix product features. You will be responsible for managing the product backlog and release scope items, including Epics, Stories, and Bugs in JIRA. Collaboration with other team leads and members is essential to ensure timely and quality release of various product deliverables using Agile methodology as per RxLogix SDLC. In this position, you will guide internal product engineering team members on domain-specific knowledge, product features, and requirements. Your responsibilities will also include conducting and leading user consortiums and workshops with clients to present upcoming product features and gather their inputs and feedback. Furthermore, you will work closely with the Engineering team to define and build prototypes that demonstrate new product features and concepts, allowing for early feedback from clients, sales team, and other stakeholders. Support for product implementation teams and clients during implementation projects is also a key aspect of this role. Your educational background should include a Bachelors/Masters degree in Technology from a reputed college, along with a minimum of 10 years of experience in the software product development industry and at least 5 years in the Pharmacovigilance domain. It is essential to have at least 3 years of experience in a product management role. A strong knowledge of the pharmacovigilance domain and key regulations such as 21 CFR Part 11, HIPAA, E2B R2/R3 from ICH, EMA, FDA, PMDA, eMDR, and eVAERS is required. Additionally, expertise in enterprise-class web-based applications and RDBMS database technologies like Oracle is essential for this role. Exceptional communication, documentation, presentation, and analytical skills are necessary, along with the ability and experience to lead and present to clients at major conferences and user group meetings. Coordination and negotiation skills are crucial for interactions within RxLogix with various departments, senior management, leads, peers, and team members from different cross-functional teams. Experience working in an Agile software development SDLC with Epics and Story-driven product management is highly valued. The ability to work effectively under pressure, handle multiple tasks simultaneously, and deliver on-time with quality is important. Personal qualities such as ownership, integrity, assertiveness, dedication, teamwork, and attention to detail will contribute to success in this role. Willingness to travel for short business trips within the country and to other countries to meet clients and internal stakeholders is a requirement for this position.,

Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimageable with us. Your Role Generate or convert doctors for our product portfolio. Secondary sales – Ensuring to achieve secondary sales targets through prescription generation by each of his BE. Good at relationship with KOLs (Top Physicians, Endocrinologists & Cardiologists) Day to day sales reporting Effective query handling and customer queries. Ensuring 100% Implementation of Company’s strategies Pharmacovigilance (Adverse Event Reporting) – To collect adverse drugs reaction (ADR) incidences including lack of efficacy related to medicinal products up to the maximum possible level of completeness and forward to local Patient Safety team immediately within 24 hours of ADR awareness. The additional information can be submitted as soon as possible Who You Are Any graduate Freshers or minimum of 1-2 years of experience in any pharma company Should have strong product knowledge & communication skills What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of our diverse team!

OSS is a growing staffing and recruitment firm specializing in delivering top-notch talent solutions across industries. We are currently seeking an experienced and driven Pharma Recruiter to join our dynamic team and help our clients find the best talent in the pharmaceutical and life sciences domain. As a Pharma Recruiter , you will be responsible for sourcing, screening, and placing qualified candidates in pharmaceutical roles such as R&D, regulatory affairs, clinical research, quality assurance, pharmacovigilance, and manufacturing. You will work closely with hiring managers and account teams to understand job requirements and deliver timely recruitment solutions. Key Responsibilities: Partner with clients and internal teams to understand pharma-specific hiring needs. Source candidates through job boards, social media, professional networks, referrals, and internal database. Conduct in-depth screening interviews to evaluate technical skills, experience, and cultural fit. Maintain a pipeline of qualified candidates for current and future openings. Manage the full recruitment life cycle—from sourcing to offer negotiation and onboarding. Stay updated on industry trends, market salary data, and regulatory compliance. Ensure a positive candidate experience throughout the hiring process. Maintain accurate records in the applicant tracking system (JOBDIVA). Qualifications: Bachelor’s degree in life sciences, HR, or related field (preferred). 1–5 years of recruiting experience in the pharmaceutical/biotech/life sciences industry. Strong understanding of pharma-related roles and terminology. Proficiency with sourcing tools. Excellent communication, interpersonal, and organizational skills. Ability to work in a fast-paced and dynamic environment. Experience with Applicant Tracking Systems (ATS) is a plus. Why Join Us? Competitive salary + performance incentives Opportunity to work with leading pharma clients Collaborative and growth-oriented work culture Continuous learning & development support

Location: Kukatpally, Hyderabad Company: ClinEdify Solutions Pvt. Ltd. Experience Required: 4+ years in EdTech Sales & Team Management Employment Type: Full-time CTC: [As per industry standard / Negotiable] About Us: ClinEdify is a dynamic and fast-growing EdTech startup revolutionizing education in clinical research, pharmacovigilance and medical domains. We’re building India’s most career-oriented life sciences training ecosystem. We are looking for a high-performing Sales Head to join our leadership team and drive the company’s sales growth from day one. Role Overview: We are seeking an experienced and passionate Sales Head with a strong track record in EdTech sales, marketing strategy, team leadership, revenue generation and startup growth handling. You will be responsible for developing and executing scalable sales strategies, building and leading the sales team and driving exponential growth from zero to scale. Key Responsibilities: Sales Leadership : Build, mentor and manage the sales team to achieve ambitious monthly and quarterly revenue targets. Revenue Generation: Take full ownership of revenue KPIs. Consistently meet or exceed sales quotas through effective pipeline management. Marketing Strategy: Collaborate with the marketing team to design and implement lead generation, funnel optimization, and campaign strategies. Startup Execution: Manage day-to-day operations with an agile mindset. Be hands-on and adaptable to startup challenges and rapid changes. Sales Funnel Management: Design, track and optimize sales funnels to improve conversion rates and lead nurturing. Lead Generation: Leverage CRM tools, LinkedIn, cold outreach and inbound channels to ensure a strong lead pipeline. Reporting: Monitor team performance, generate detailed reports and make data-driven decisions to improve results. Cross-Functional Collaboration: Work closely with Founders, Product and Training teams to align sales strategies with business goals. Client Engagement: Maintain strong relationships with B2B and B2C clients. Ensure customer satisfaction and retention. Requirements: Minimum 4 years of EdTech or B2C sales experience, with at least 2 years in a leadership/managerial role. Proven track record of revenue generation and team scaling. Strong experience in digital marketing strategy and lead funnels. Entrepreneurial mindset – must be comfortable working in a fast-paced startup environment. Excellent communication, negotiation and closing skills. Experience with CRM tools (Zoho, HubSpot, etc.) and sales analytics. High ownership and a positive, growth-oriented attitude. Ability to start and scale from Day 1 with a fresh team. Preferred Qualifications: MBA in Marketing / Sales / Business or equivalent experience. Experience in the clinical research, life sciences or education industry is a strong plus. Exposure to bootstrapped or early-stage startup environments. What You’ll Get: Opportunity to be a core part of a growing EdTech brand. Fast-track career growth into leadership or CXO roles. Performance-based incentives and ESOP opportunities (if applicable). Dynamic work environment with flexibility and ownership. To Apply : immediate joiners, send your updated resume and a brief pitch on why you're the right fit to info@clinedify.com contact: 9032560517

Job Overview Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations SOPs and internal guidelines under guidance and support of senior operation team members. Essential Functions To Prioritize and complete the assigned trainings on time. Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements. To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events(AE)/endpoint information determining initial/update status of incoming events database entry coding AE and Products, writing narratives, Literature related activities as per internal/ project timelines. Ensure to meet quality standards per project requirements. Ensure to meet productivity and delivery standards per project requirements. To ensure compliance to all project related processes and activities. Creating, maintaining and tracking cases as applicable to the project plan. Identify quality problems, if any, and bring them to the attention of a senior team member. To demonstrate problem solving capabilities. To mentor new teams members, if assigned by the Manager. Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes. 100% compliance towards all people practices and processes Perform other duties as assigned. Qualifications High School Diploma or equivalent Scientific or healthcare discipline or allied life sciences Req An Individual with a minimum of a Bachelor’s Degree in scientific or healthcare discipline or allied life sciences graduation with 1-1.5 years of relevant experience. Req Good knowledge of medical terminology. Intermediate Working knowledge of applicable Safety Database. Beginner Knowledge of applicable global, regional, local clinical research regulatory requirements. Beginner Excellent attention to detail and accuracy. Beginner Good working knowledge of Microsoft Office and web-based applications. Beginner Strong organizational skills and time management skills. Beginner Strong verbal/written communication skills. Intermediate Self-motivated and flexible. Intermediate Ability to follow instructions/guidelines, utilize initiative and work independently. Intermediate Ability to multi-task, manage competing priorities and deadlines. Beginner Ability to delegate to less experienced team members. Beginner Willingness and aptitude to learn new skills across Safety service lines. Beginner Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients. Beginner Ability to work as a Team Player, contribute and work towards achieving Team goals. Beginner Ensure quality of deliverables according to the agreed terms. Beginner Demonstration of IQVIA core values while doing daily tasks Beginner Extensive use of telephone and face-to-face communication requiring accurate perception of speech. Beginner Regular sitting for extended periods of time. Beginner May require occasional travel. Beginner Flexibility to operate in shifts. Beginner IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

The Digital Governance team supports the Global Regulatory Affairs and Strategy organization in the constant pursuit of Execution Excellence. They do this by managing the tracking and documentation of Amgen s global digital sites and projects for compliance purposes. The Sr. Associate Digital Governance will support the Digital Governance Business Process Owner (DSR BPO) in maintaining the accuracy of Amgen s global digital site database. They are responsible for ensuring database records are kept up to date, responding to inquiries for database reports, following up on pending actions, and assisting users with process-related questions. This role will be on a flex shift to allow for live training and collaboration. Roles & Responsibilities: Support tracking and documentation of Amgen s global digital sites and projects for compliance purposes Promote compliance for Amgen s digital and social media asset inventory Provide guidance to inquiries regarding Amgen s global digital database Assign training as needed to Amgen employees who manage or support digital assets Update formal process documents (SOPs, guidance/training documents) as needed Quality check digital assets against database information to ensure accuracy Follow up on overdue database task assignments Work with Domain Law to register Amgen URLs Support Digital Governance management in identifying areas of risk and concern Execute and document effectiveness checks Support corrective actions and regulatory inspections Maintain weekly and quarterly database reports Test digital site contact information to ensure compliance Provide Project Management support to key initiatives Maintain project management standards and methodology Provide change management support to key initiatives Required Knowledge and Skills: Deep knowledge of Veeva PromoMats database management processes Excellent written/oral communication skills and attention to detail Strong problem-solving skills and the ability to navigate complex situations Adaptability to assist in meeting urgent goals in a complex environment Familiarity with pharmaceutical regulatory compliance requirements (US and global) Experience with social media and website management Knowledge of Excel Ability to work collaboratively in a team environment Project Management Change Management Preferred Knowledge and Skills: Understanding of pharmaceutical regulatory compliance requirements in a global database environment Awareness of social media requirements and processes Basic Education and Experience: Master s degree OR Bachelor s degree and 3 years of related experience OR Associate s degree and 5 years of related experience Preferred Education and Experience: Master s or bachelor s degree Experience working in a Global Regulatory Affairs or Pharmacovigilance organization AIN working hours for this position: This position supports the Regulatory Promotion and Material Compliance activities serving Amgen s US Business Operations and thus the AIN working hours will need to be flexible with occasional overnight work time when needed to support product launches and new indications. EQUAL OPPORTUNITY STATEMENT .

Let s do this. Let s change the world. In this vital role you will Support the R&D quality Audit and help to build quality into everything Amgen does. Data entry into Amgen s Quality System of approved audit responses Audit resourcing/planning Quarterly Investigator Site audit planning including identifying audit resourc es t hrough risk assessment of audit targets on a regular basi s Yearly planning of other audit types including internal process/Service Provider and Affiliate Audits Updating Audi t tracking and accountability t ools and distrib uting/communicatin g all ocations to the audit teams Compiling Audit reporting metrics and communication Manage Audit documentation and filing Supporting outsourced audits by: Supporting outsourced audit resourcing/planning for Audits Provide necessary tools, reports/documentation, and access to systems for outsourced Audits Review initial draft audit reports, audit responses and debrief slides. Schedule and facilitate Quality Lead (pre-audit meetings) and audit debrief meetings QC Data entry into AMS of audit findings Confirming data entry into RDCS of approved audit responses Oversee timelines met for issuance of Initial audit reports; review of audit responses and issuing Final Audit Reports Provide guidance and resolve queries from external Audit vendors Weekly Meeting with external audit vendor to review tasks and status of audits Communicate noncompliance to Manager Administrative Support (includes maintaining & updating distribution lists and templates) Data entry/QC in to the Audit Management System (Trackwise) of audit findings Administrative support for audit resourcing/planning Manages Audit documentation and filing Ensures that the Audit Archive is updated with Final audit reports and closure memos and Plans/Agendas where applicable Follow up with CAPA Owners for completion dates and objective evidence Review and Append Objective evidence in Amgen s Quality System and close record What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Quality professional we seek has a can do approach with these qualifications. Basic Qualifications: Master s degree in Life sciences or related field Preferred Qualifications: Minimum of 3-5 years in biopharmaceutical industry experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility. Experience supporting regulatory authority inspections of clinical research, and/or pharmacovigilance activities Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Track wise. Quality Assurance Qualification/Certification (preferred)

This position plays a role in the authoring, compilation and peer review of Amgen s Periodic Aggregate Safety Reports (PASR) e.g. Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR), Semi Annual Safety Update Report (SSUR), Periodic Adverse Drug Experience Report (PADER/PAER), Device PSUR, and country specific reports e.g. Korea PSUR, Brazil PSUR and Colombia Clinical Research Annual Safety Report Submission and Evaluation form. In compliance with global regulatory requirements. This role supports the end-to-end writing and documentation process and ensures timelines are met. Key Responsibilities: Compilation and authoring of PASRs Coordinate and schedule all meetings with cross-functional stakeholders to ensure effective collaboration and alignment Drive report timelines and escalate risks or delays to team leads or management Collaborate with cross-functional stakeholders and external business partners to collect PASR contributions and compile into PASR template. Author safety content for all PASRs in collaboration with Therapeutic Area Safety scientists Conduct peer QC of safety authored sections, coordinate Amgen review and resolve comments and initiate approval workflows. Maintain and archive accurate records and documentation throughout the report process. Review and approve published report versions (i.e. blinded, unblinded, EU FDA, Rest of World). Manage report distribution to Contract Research Organizations (CROs) and Business Partners (BPs) Ensure adherence to established timelines, regulatory guidelines and applicable standards, styles, guidelines and processes Peer review/quality review of all PASRs within established timelines with adherence to applicable guidelines and processes, using appropriate checklists Maintain and develop current knowledge of regulatory guidelines, technological advances and industry standards Generate PASR metrics, including Key Compliance Indicators (KCIs) and Key Performance Indicators (KPIs). Literature Management Process May assist with Literature Management activities as required Basic Qualification and Experience: Master s degree or Bachelors degree with 5 years of experience

As a Sr Associate IS Analyst, you will join a collaborative team implementing and supporting the next generation of safety platforms and supporting existing & future technologies. In this role, you will analyze and resolve issues with adverse event data and file transmissions across integrated systems, leveraging data analysis to identify trends, optimize workflows, and prevent future incidents. Collaborating closely with various teams, you will develop insights and implement solutions to improve system performance, ensuring reliable and efficient adverse event flow to critical safety operations. Roles & Responsibilities: Monitor, solve, and resolve issues related to adverse event distribution processing across multiple systems. Conduct detailed investigations into system disruptions, data anomalies, or processing delays and implement corrective and preventive measures. Work closely with internal teams, external vendors, and business partners to address dependencies and resolve bottlenecks for critical issues Design and maintain dashboards, reports, and analytics to monitor system performance and identify trends or areas of improvements. Present findings and recommendations to leadership, ensuring data-driven decision-making and clear transparency into system operations. Identify inefficiencies and propose data-driven solutions to optimize and enhance reliability. Collaborate on the development of test plans, scenarios to ensure robust validation of system updates, patches and new features Perform regression testing to verify the changes do not negatively impact existing system functionality Support the creating and implementation of automated testing frameworks to improve efficiency and consistency Support compliance with Key Control Indicators (KCI) and chips into overall process governance What we expect of you Basic Qualifications and Experience: Master s degree and 1 to 3 years of experience in Computer Science, IT or related field OR Bachelor s degree and 3 to 5 years of experience in Computer Science, IT or related field OR Diploma and 7 to 9 years of experience in Computer Science, IT or related field Functional Skills: Must-Have Skills: Demonstrated expertise in monitoring, troubleshooting, and resolving data and system issues. Experienced in database programming languages using SQL. Experience with File transfer processes and tackle stuck or delayed files. Collaborative spirit and effective communication skills to seamlessly work in a cross-functional team. Experienced in Agile methodology Hands-on experience with the ITIL framework. Knowledge of SDLC process, including requirements, design, testing, data analysis, change control. Good-to-Have Skills: Experience with API integrations such as MuleSoft, Data Bricks platforms. Experience with programming languages such as Python. Experienced in managing GxP systems and implementing GxP projects. Extensive experience with Software Development Lifecycle (SDLC). 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. Familiarity with cloud technologies such as AWS, Azure. Ability to explain technical concepts to non-technical clients. High Level Understanding on Pharmacovigilance Terminologies or R&D IT process Experience on any existing PV system like ARGUS, arisG,.. is added advantage. 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 Ability to deal with ambiguity and think on their feet 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. Shift Information: This individual contributor 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.

Career Category Safety Job Description Join Amgen s Mission of Serving Patients At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lie within them, you ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Group Purpose Group is accountable for global literature surveillance activities for all Amgen portfolio of products. Responsible for performing the weekly review of literature articles for signal detection and identification of safety reports. Job Summary This position is responsible for performing routine weekly reviews of literature articles retrieved from Embase, Medline, and BIOSIS, which are the bibliographic databases used for Amgen s global literature surveillance. The review supports signal detection for all Amgen portfolio of products and identification of individual case safety reports (ICSRs) for marketed products. Key Responsibilities: Literature Management Process Perform review of literature results retrieved and imported into literature citation management system on a weekly basis and determine if minimum criteria for ICSR is met for marketed products Perform review of literature results to determine if article contains new aggregate safety information in support of the periodic report and/or signal detection Determine whether the full text article needs to be ordered and order them if further information is needed to confirm if citation meets criteria for ICSR or for signal detection Flag articles containing new aggregate safety information for TA Safety to perform secondary review Request Local Safety Officer to provide English translation if the article is not in English Notify business partner of articles received, if applicable Perform retrospective quality checks on the quality of the literature review performed by team Support audits and inspections Collaborate with Case Management and TA Safety on process improvement initiatives Proactively proposes and system and process improvement ideas Periodic Reporting Process May assist with quality control of periodic reporting activities as required. Extract list of citations for inclusion in periodic reports Key Activities Responsible for routine review of literature articles as part of the global literature surveillance process Assist with quality control of periodic reporting activities Support audits and inspections by extracting requested citations from literature citation management system Knowledge and Skills Knowledge of product profiles for products assignment Ability to identify literature articles containing ICSR criteria or aggregate safety findings supporting signal detection Ability to order full text articles where needed Ability to receive feedback from Case Management and TA Safety and optimize quality of literature review Demonstrate knowledge of global aspects of pharmacovigilance Strong knowledge of processes and global regulations for pharmacovigilance and literature surveillance Ability to effectively manage competing priorities and timelines Strong knowledge of literature citation management systems and platform used to configure search strategies Experience in use of AI and prompts would be useful CONTRIBUTION: Ensures Amgen remains in compliance and maintains high quality global literature review process Responsible for the timely completion of review of weekly literature results Education & Experience (Basic) 5-9 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting. Knowledge of bibliographic databases and direct literature review experience (preferred) What you can expect from us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Job Summary The Global Safety Officer (GSO) for Marketed Products serves 2 roles: 1) safety expert of the assigned marketed product(s), establishing the strategy, direction, and priorities of pharmacovigilance activities. The GSO is accountable for the overall safety profile and all product-related decisions and deliverables for assigned marketed products. The GSO leads the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC). The GSO also is a member of the Evidence Generation Team. The GSO will be assigned as delegate for the TAH as needed and has management of Global Safety Scientists. Key Activities Applicable tasks may vary by product(s) assigned. Product safety profile, benefit-risk evaluation, and risk communication: Accountable for the Development and maintenance of core reference safety information (e.g Core safety information portions of Core Data Sheet [CDS]) Identify relevant data and conduct benefit-risk evaluation Participate in product label process Clinical trial safety: Develop a strategy as needed for preparing and updating safety related portions of the Informed Consent Form and other study related documents for trials conducted post marketing. Develop strategy for and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees Perform signal detection activities for developmental products under the direction of the GSO leading the product in development. Signal detection, evaluation, and management: Develop signal detection strategy Evaluate safety signal detection findings, validate signals and determine a need and develop a strategy for further analysis Decide on need for further actions on safety issues and lead cross-functional discussion Documents work as required in the safety information management system Prepares and presents recommendations on safety issues to the Global Safety Team and escalates as appropriate to the executive level cross-functional decision-making body Approves the safety assessment report May search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection Documents work as required in the safety information management system Risk management and minimization: Ensure timely preparation, content, and quality of new or updated risk management plan (RMP) document Develop a strategy for safety risk minimization measures globally (including US REMS if applicable) Develop materials for additional risk minimization measures as applicable to role Periodic (aggregate) safety reporting: Ensure timely preparation and quality of periodic reports (e.g., PSUR/PBRER) Review and approve periodic safety reports Safety Governance Leadership: Participates in safety governance meetings per Standard Operating Procedures and Manuals (e.g. Facilitates, Chairs, Presents) Amgen commercialization process: Represents and contributes on behalf of Global Patient Safety on Evidence Generation Teams Inspection Readiness: Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility Partnerships and integration activities Participate in safety agreement development and review process Prepare safety information to support licensing partners, review safety documents prepared by licensing partners, and communicate with licensing partners on safety matters per the safety agreement Perform safety due diligence in preparation for partnerships, etc. Participate in integration activities Other Amgen processes: Interact with external stakeholders (e.g., advisory boards) on safety-related topics Prepare for and participate in regulatory agency advisory committees Provide safety input to support legal needs Managerial and supervisory responsibilities Oversees day to day activities of the Global Safety Physician if applicable Ensure staff are compliant with Amgen corporate and departmental training and SOP review Provide training, coaching, mentoring, and development of staff Assist in the recruitment of talented GPS and AMGEN staff Accountable for disseminating and representing corporate and departmental information to staff and ensuring understanding and adherence to changes Development plans for staff created annually and reviewed quarterly Education & Experience (Preferred) Medical Degree (MBBS or MD) required from an accredited medical school with atleast 8 years of relevant experience . Product safety in the bio/pharmaceutical industry/CRO or regulatory agency Previous management and/or mentoring experience Clinical/medical research experience

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 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.

The Quality Compliance Senior Manager is a global role and part of the Clinical & Research Quality (CRQ) team for the R&D Quality Organization. CRQ organization plays a critical role in ensuring that our research and development activities are conducted in an ethical and responsible manner . CRQ is responsible for ensuring that our research and development activities meet the highest standards of quality and compliance, ultimately keeping patients safe, protecting their welfare, while ensuring that all data produced has integrity. In this vital role , the Quality Compliance Senior Manager will contribute to providing leadership to ensure excellence in R&D Quality Processes is maintained through oversight and improvements when compliance issues are identified In addition, this role will serve as a mentor for Amgen staff in India who will be working to advance the Quality System, and they will act to manage day to day activities for the team. They will be an integral team member working globally with Business Process Owners to ensure compliance with regulations and other business requirements. This role will be part of supporting the digital quality management system (DQMS) as a Subject Matter Expert ( SME ) to support the core processes managed in Quality. Additionally, the Quality Compliance Senior Manager will provide proactive end to end quality support for the management of Quality Incidents/Quality Events , working closely with Quality Leads in approving investigations , including root cause analysis (RCA) and C orrective & Preventive Action (C APA ) plans. Roles & Responsibilities: The Quality Compliance Senior Manager will work both independently and in a team environment to foster collaborative relationships with in R&D Quality. In this vital role , they will be responsible for supporting processes and operational activities related to ; overseeing deviations, preparation of audits and inspections across R&D Quality including Good Pharmacovigilance Practice ( GPvP ), Good Clinical Practice (GCP) and Good Laboratory Practice (GLP). As part of strengthening and advancing Amgen s R&D QMS, this role provides end-to-end quality support to Deviation owners, RCA owners, and CAPA owners. Manages the Amgen India R&D Quality team to ensure that the team is supported and managed on a day-to-day basis. Support s the intake, triage, and categorization of deviations, ensuring appropriate classification and documentation. Facilitate s timely and thorough deviation investigations in collaboration with functional area r epresentatives and Quality Leads. E nsure s consistent and compliant documentation of deviation records within the electronic quality management system ( D QMS). Monitor s and ensure s adherence to timelines, escalating delays and risks as needed. Support s Global Patient Safety and Global Development teams in GxP inspection management activities and GxP audits from business partners Identif ies , lead s , or contribute s to continuous improvement initiatives to enhance CAPA management practices. Collaborate s with cross-functional partners to ensure processes remain effective, efficient, and aligned with industry best practices and evolving regulations. Ensure s the integrity, traceability, and quality of deviation and CAPA records in compliance with ALCOA+ principles. Monitor s quality metrics and key performance indicators (KPIs) related to deviation and CAPA management. Analyses trends and perform root cause trending to identify systemic issues and opportunities for process improvement. Manage s , organize s and analyse s data through different systems, tools, or platforms, including Excel and Smartsheet Maintain s knowledge of current regulatory and quality practices/issues Maintain s the Global R&D CRQ and SMQ SharePoint sites Manage s the appropriate archival and retention of audit documentation. Basic Quali fi cations and Experience: Master s degree with 10-12 years of Pharma and Biotech R&D or commercial manufacturing Quality experience. Continuous Improvement/Change Management experience is preferred Additional Competencies/Skills: Exceptional attention to detail and accuracy in all deliverables. Ability to work independently and proactively in a fast-paced environment. Proficiency in Smartsheet, Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and virtual collaboration tools (e.g., Teams, WebEx ) Good team building skills and the ability to on-board new employees and develop them over time Familiarity with project management tools and methodologies. Knowledge of GCP, GLP and/or GPvP . Experience working in a multinational environment with global teams. Excellent verbal and written communication skills. High degree of professionalism and interpersonal skills. Strong problem-solving abilities and adaptability to changing priorities. Collaborative attitude and ability to build positive relationships across diverse teams. Resilience, discretion, and the ability to thrive under pressure

Let s do this. Let s change the world. The primary responsibility of this role is to perform quality control reviews of of Amgen s Periodic Aggregate Safety Reports (PASR) e.g. Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR), Semi Annual Safety Update Report (SSUR), Periodic Adverse Drug Experience Report (PADER/PAER), Device PSUR, and country specific reports e.g. Korea PSUR, Brazil PSUR and Colombia Clinical Research Annual Safety Report Submission and Evaluation form. The QC Reviewer will ensure accuracy, consistency, and compliance with regulatory and company standards. This role supports the end-to-end writing and documentation process and ensures timelines are met. Key Responsibilities: Conduct thorough quality control reviews of PBRER/PSURs, DSURs, PADER/PAERs, and other aggregate safety reports to ensure content accuracy, data integrity, formatting consistency, and adherence to regulatory and internal requirements. Verify correct incorporation of safety data, narratives, tables, and appendices, ensuring alignment with source documents and databases. Collaborate with Periodic Report Specialists to address discrepancies and ensure timely resolution of quality issues. Maintain up-to-date knowledge of global regulatory requirements and industry standard methodologies for periodic safety reporting. Contribute to the development and refinement of QC checklists, templates, and SOPs to ensure consistent review practices. Track QC metrics and support continuous improvement initiatives related to safety report quality and delivery. Responsible for performing QC reviews of periodic safety reports to ensure compliance with the style guide, templates, and contributor inputs. Responsible for verifying content accuracy, data integrity, and consistency across all report components. Responsible for collaborating with Periodic Report Specialist to resolve QC findings and ensure timely delivery of high-quality reports. Inspection Readiness: Support inspection readiness efforts by ensuring all QC activities are well-documented, traceable, and compliant with applicable regulatory requirements. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree and 1 to 3 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience OR Bachelor s degree and 3 to 5 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience OR Diploma and 7 to 9 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience Strong attention to detail with the ability to identify inconsistencies and errors in complex regulatory documents. Proven ability to operate effectively in a collaborative environment requiring coordination, communication, and analytical judgment. Solid understanding of pharmacovigilance principles and global regulatory requirements related to periodic aggregate reporting (e.g., PBRERs, DSURs, PADERs). Proficiency in scientific and technical writing/editing, with an emphasis on quality control and adherence to style guides and templates. Excellent written and verbal communication skills in English, with strong organizational and time management abilities. Demonstrated ability to manage competing priorities and strict deadlines while maintaining high-quality standards. Familiarity with the structure and content of safety reports and the ability to interpret and validate data inputs from multiple contributors. Proficient in Microsoft Office tools (Word, Excel, PowerPoint), Adobe Acrobat, and document management systems (e.g., Veeva Vault, SharePoint). Working knowledge of AI tools and prompt use is a plus, especially for enhancing QC efficiency. Team-oriented approach with the ability to work cross-functionally to support compliance and inspection readiness efforts. Contribution: Ensures Amgen remains in compliance and becomes best in class with regard to periodic aggregate report processes Implements and maintains document standards Responsible for successful tracking of metrics, timelines, and performance indicators for PASR objectives. Preferred Qualifications: Health Care Professional with minimum 2 - 3 years of relevant work experience Including 1 to 2 years of experience in periodic aggregate safety report writing OR Bachelor s / Master s degree in Health/Life Sciences with minimum 2 - 3 years of Overall 2 + years of authoring/editing experience in medical writing domain across different therapeutic areas in safety documents including Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR). Experience in preparation of safety documents necessary for national and international regulatory submissions to the US, European Union and other regulatory agencies. Knowledge of Pharmacovigilance regulations for Periodic Aggregate Safety Reports. 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.

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.

Career Category Safety Job Description Join Amgen s Mission of Serving Patients At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lie within them, you ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Group Purpose Integrated Signal Management group is responsible for the direction and strategy for safety signal detection and management, safety governance, and quality complaints trending and analytics. It drives policies, research, definition and implementation of innovation and best practices for safety data mining, signal detection planning, management, tracking, product complaints trending and analytics; risk management practices, benefit/risk assessment and safety communications while ensuring quality processes with proven metrics. Job Summary The Innovation Specialist will serve as a key strategic partner within the Signal Management and Post-Market Surveillance & Trending organization, focused on identifying, evaluating, and implementing emerging technologies and AI/ML-enabled analytical tools in collaboration with the ISM Data Science team. This role will bridge scientific, technical, and business functions to co-develop innovative surveillance capabilities that monitor the safety and quality of Amgen products. Key Activities Technology Scouting & Evaluation - Monitor and evaluate industry trends, emerging technologies, academic research, and vendor solutions related to AI/ML for post-market safety and product complaints surveillance. Maintain a landscape of external vendors offering signal detection, NLP, and data analytics solutions relevant to product surveillance. Collaboration & Innovation Development - Partner with the ISM Data Science team to assess feasibility, develop prototypes, and deploy AI/ML models for signal detection and augmentation of signal assessment Engage with stakeholders (e.g., TA Safety) to identify unmet needs and prioritize use cases. Facilitate workshops or ideation sessions to shape innovation roadmaps and pilot initiatives. Promote adoption of industry best practices and ensure compliance with regulatory guidance on AI/ML and surveillance in the context of combination products. Perform regulatory impact and risk analysis of proposed solutions Develop internal guidelines and documentation for use of advanced analytics in surveillance activities. Project Execution - Lead or support proof-of-concept and pilot initiatives for new surveillance technologies. Translate business needs into functional requirements for solution development. Track project progress, manage risks, and report findings to senior leadership. Knowledge and Skills Required Knowledge and Skills: Experience in post-market surveillance, pharmacovigilance, medical device vigilance, or related domain Knowledge of combination products and medical devices, including device safety monitoring regulations and standards Knowledge of software development concepts Experience with market scanning, vendor/product evaluation Knowledge of regulatory framework and guidance of principles for AI in the medicinal product lifecycle Preferred Knowledge and Skills: Demonstrated experience working with or evaluating AI/ML tools, safety analytics, natural language processing (NLP), or data mining. Strong project management, cross-functional collaboration, and communication skills Education & Experience 8-13 years of industry experience Experience with market scanning, vendor/product evaluation Experience working with AI/ML and/or automation tools Strong project management, cross-functional collaboration, and communication skills What you can expect from us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Career Category Safety Job Description Join Amgen s Mission of Serving Patients At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lie within them, you ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Group Purpose Group is accountable for global literature surveillance activities for all Amgen portfolio of products. Responsible for performing the weekly review of literature articles for signal detection and identification of safety reports. Job Summary This position is responsible for performing routine weekly reviews of literature articles retrieved from Embase, Medline, and BIOSIS, which are the bibliographic databases used for Amgen s global literature surveillance. The review supports signal detection for all Amgen portfolio of products and identification of individual case safety reports (ICSRs) for marketed products. Key Responsibilities: Literature Management Process - Perform review of literature results retrieved and imported into literature citation management system on a weekly basis and determine if minimum criteria for ICSR is met for marketed products Perform review of literature results to determine if article contains new aggregate safety information in support of the periodic report and/or signal detection Determine whether full text article needs to be ordered and order them if further information is needed to confirm if the citation meets criteria for ICSR or for signal detection Flag articles containing new aggregate safety information for TA Safety to perform secondary review Request Local Safety Officer to provide English translation if the article is not in English Notify business partner of articles received, if applicable Perform retrospective quality checks on the quality of the literature review performed by team Support audits and inspections Collaborate with Case Management and TA Safety on process improvement initiatives Proactively proposes and system and process improvement ideas Provide training and onboarding to junior staff Perform Quality checks on literature reviews performed by other staff Periodic Reporting Process - May assist with quality control of periodic reporting activities as required. Extract list of citations for inclusion in periodic reports Key Activities Responsible for routine review of literature articles as part of the global literature surveillance process Assist with quality control of periodic reporting activities Support audits and inspections by extracting requested citations from literature citation management system Knowledge and Skills Knowledge of product profiles for products assignment Ability to identify literature articles containing ICSR criteria or aggregate safety findings supporting signal detection Ability to order full text articles where needed Ability to receive feedback from Case Management and TA Safety and optimize quality of literature review Demonstrate knowledge of global aspects of pharmacovigilance Strong knowledge of processes and global regulations for pharmacovigilance and literature surveillance Ability to effectively manage competing priorities and timelines Strong knowledge of literature citation management systems and platform used to configure search strategies Experience in use of AI and prompts would be useful CONTRIBUTION: Ensures Amgen remains in compliance and maintains high quality global literature review process Responsible for the timely completion of review of weekly literature results Education & Experience (Basic) 8-13 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting Knowledge of bibliographic databases and direct literature review experience (preferred) What you can expect from us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Career Category Research Job Description Job Summary The Global Safety Officer (GSO) for Marketed Products serves 2 roles: 1) safety expert of the assigned marketed product(s), establishing the strategy, direction, and priorities of pharmacovigilance activities. The GSO is accountable for the overall safety profile and all product-related decisions and deliverables for assigned marketed products. The GSO leads the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC). The GSO also is a member of the Evidence Generation Team. The GSO will be assigned as delegate for the TAH as needed and has management of Global Safety Scientists. Key Activities Applicable tasks may vary by product(s) assigned. Product safety profile, benefit-risk evaluation, and risk communication: Accountable for the Development and maintenance of core reference safety information (e.g Core safety information portions of Core Data Sheet [CDS]) Identify relevant data and conduct benefit-risk evaluation Participate in product label process Clinical trial safety: Develop a strategy as needed for preparing and updating safety related portions of the Informed Consent Form and other study related documents for trials conducted post marketing. Develop strategy for and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees Perform signal detection activities for developmental products under the direction of the GSO leading the product in development. Signal detection, evaluation, and management: Develop signal detection strategy Evaluate safety signal detection findings, validate signals and determine a need and develop a strategy for further analysis Decide on need for further actions on safety issues and lead cross-functional discussion Documents work as required in the safety information management system Prepares and presents recommendations on safety issues to the Global Safety Team and escalates as appropriate to the executive level cross-functional decision-making body Approves the safety assessment report May search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection Documents work as required in the safety information management system Risk management and minimization: Ensure timely preparation, content, and quality of new or updated risk management plan (RMP) document Develop a strategy for safety risk minimization measures globally (including US REMS if applicable) Develop materials for additional risk minimization measures as applicable to role Periodic (aggregate) safety reporting: Ensure timely preparation and quality of periodic reports (e.g., PSUR/PBRER) Review and approve periodic safety reports Safety Governance Leadership: Participates in safety governance meetings per Standard Operating Procedures and Manuals (e.g. Facilitates, Chairs, Presents) Amgen commercialization process: Represents and contributes on behalf of Global Patient Safety on Evidence Generation Teams Inspection Readiness: Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility Partnerships and integration activities Participate in safety agreement development and review process Prepare safety information to support licensing partners, review safety documents prepared by licensing partners, and communicate with licensing partners on safety matters per the safety agreement Perform safety due diligence in preparation for partnerships, etc. Participate in integration activities Other Amgen processes: Interact with external stakeholders (e.g., advisory boards) on safety-related topics Prepare for and participate in regulatory agency advisory committees Provide safety input to support legal needs Managerial and supervisory responsibilities Oversees day to day activities of the Global Safety Physician if applicable Ensure staff are compliant with Amgen corporate and departmental training and SOP review Provide training, coaching, mentoring, and development of staff Assist in the recruitment of talented GPS and AMGEN staff Accountable for disseminating and representing corporate and departmental information to staff and ensuring understanding and adherence to changes Development plans for staff created annually and reviewed quarterly Education & Experience (Preferred) Medical Degree (MBBS or MD) required from an accredited medical school with atleast 8 years of relevant experience . Product safety in the bio/pharmaceutical industry/CRO or regulatory agency Previous management and/or mentoring experience Clinical/medical research experience .

Career Category Safety Job Description The PV Scientist Manager is responsible for the following: Contributes to the planning, preparation, writing and review of non-medical portions of aggregate reports Works with affiliates and other internal Amgen partners regarding deliverables Review of AE/SAEs from clinical trials as needed Contributes under the direction of the Global PV Sr. Scientist or Lead to: Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents Review standard design of tables, figures, and listings for safety data from clinical studies Participate in development of safety-related data collection forms for clinical studies Attend study team meetings as requested or needed Conduct signal detection, evaluation, and management Perform data analysis to evaluate safety signals and write up analysis results in collaboration with GSO Prepare safety assessment reports and other safety documents and regulatory responses Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection Participates in Safety Governance per Amgen processes Prepare presentation of the Global Safety Team s recommendations on safety issues to the cross-functional decision-making body Assist GSOs and other Senior Scientists in the development of risk management strategy and activities Provides contents for risk management plans Update strategy and content for regional risk management plans Assist GSOs to oversee risk minimization activities including tracking of activities as needed Evaluate risk minimization activity Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO Support activities related to new drug applications and other regulatory filings Assist GSO/ or other Senior Scientist in developing a strategy for safety-related regulatory activities Provide safety contents for filings Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor Inspection Readiness: Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility The PV Scientist contributes to GPS in the following ways: Contribute to the development, improvement, and standardization of pharmacovigilance processes and methods Participates on teams for the implementation of new processes and methods within the Therapeutic Area Basic Qualifications and Experience: Master s or Bachelors degree with minimum 9+ years of experience in relevant fields. .

Career Category Safety Job Description The Global Safety Therapeutic Areas serve as the safety experts for all Amgen products globally and are accountable for the safety strategy and major safety deliverables for each Amgen product. 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 to worldwide regulations. The Global PV Sr. Scientist works with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations. This person will also provide scientific and compliance expertise as needed to GPS. Applicable tasks may vary by product(s) assigned. The Global PV Sr. Scientist is responsible for the following: Directs the planning, preparation, writing and review of portions of aggregate reports Organize and direct liaison for activities with affiliates and other internal Amgen partner regarding products Supports and provides oversight to staff with regards to safety in clinical trials to: Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents Review of AEs/SAEs from clinical trials as needed Review standard design of tables, figures, and listings for safety data from clinical studies Participate in development of safety-related data collection forms for clinical studies Participate in study team meetings as requested or needed Signal detection, evaluation, and management- Perform data analysis to evaluate safety signals and write up analysis results Documents work as required in the safety information management system Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSO Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection Prepare presentation of the Global Safety Team s recommendations on safety issues to the cross-functional decision-making body Assist GSO in the development of risk management strategy and activities: Provides contents for risk management plans Develop or update strategy and content for regional risk management plans Assist GSOs to oversee risk minimization activities including tracking of activities as needed. Evaluate risk minimization activity Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO Support activities related to new drug applications and other regulatory filings Assist GSO in developing a strategy for safety-related regulatory activities Provide safety contents for filings Inspection Readiness Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility Knowledge and Skills Processes and regulations for pharmacovigilance and risk management Drug development and lifecycle management Safety data capture in clinical development and post-market settings Safety database structure and conventions MedDRA and other dictionaries used in pharmacovigilance Methods of qualitative and quantitative safety data analysis Product and disease state knowledge Risk management and risk minimization Inter-relationship across various pharmacovigilance processes and documents, including reference safety information and product labelling Advanced understanding of interfaces across various pharmacovigilance and risk management processes Internal organizational and governance structure Pharmacovigilance skills-intermediate knowledge of the following: Signal detection, evaluation and management Aggregate data analysis, interpretation and synthesis Good clinical and scientific judgment Application of medical concepts and terminology Document writing and source document review Writing Risk Management Plans Ability to convey complex, scientific data in an understandable way Ability to analyze and interpret complex safety data Intermediate skills in application of statistical and epidemiological methods to pharmacovigilance Biomedical Literature-intermediate skills: Literature Surveillance: source document review knowledge and skills Literature search, evaluation and assessment skills-ability to search literature databases to identify safety literature for signal evaluation and assessment, interpretation and synthesis skills Other skills-intermediate skills in the following Organization, prioritization, planning skills Collaboration with cross-functional team settings Meeting management and time management skill Process and project management Critical scientific assessment and problem solving Strong Written and verbal communications skills, including medical/scientific writing Computer skills (e.g., MS Office Suite and safety systems) Strategic thinking Influencing and negotiation in a cross-functional, matrix environment Presentation skills for conveying complex technical contents to non-expert audiences KNOWLEDGE Broad PV knowledge with expertise within defined subject area Applies knowledge and broad understanding of multiple disciplines Understands impact of emerging scientific/technical trends and their implications for Amgen PROBLEM SOLVING Analyzes and forecasts scientific/technical trends Develops solutions to problems through in-depth analysis, coordination and negotiation with key decision makers Performs complex work-flow analysis on processes impacting multiple areas across the organization Adapts and integrates own experience with Amgen-wide strategy Develops innovative solutions to problems without precedent Proposes new processes to achieve strategic business objectives Works in partnership with GPS team to develop business plans that support the direction of the business AUTONOMY Guided by business plans and strategy Executes strategy, goals and changes within area of responsibility Contributes to strategic decisions affecting the discipline Guides ideas through development into a final product CONTRIBUTION Contributes to business results through quality of results, advice and decisions related to the operations of the discipline Designs and develops global processes, systems and/or applications Contributes to organizational through leadership May accomplish business results through leveraging a team of professionals and/or managers Develops mutually beneficial strategic alliances with internal and external contacts Education & Experience (Basic) Doctorate/Master s degree/Bachelor s degree and 12 to 17 years of directly related experience Education & Experience (Preferred) BS or BA in Life Science with a MS and 12 years of related experience And 2 years of managerial experience directly managing people and or leadership experience leading teams, project, programs or directing the allocation of resources Clinical/medical research experience 6 years of experience in a biotech/pharmaceutical/CRO setting Previous management and/or mentoring experience .

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.

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.

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. Job Summary: Accountable for quality of device/combination product Individual Case Safety Reports (ICSR) processing globally for clinical trial and post-market cases. Ensure Vendors deliver high quality device/combination product cases through metric management and meet all worldwide regulatory authority requirements. Provide vendors with resources and training to perform their role. Responsible for raise of device/combination product case related issues. Providing audit/inspection support for case management related activities including liaising with vendors to provide support as applicable for device/combination products. 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. Key Activities: Work within the Quality Management System framework including all applicable training and controlled documentation governing Pharmacovigilance processes. Ensures compliance and timely reporting with device/combination product cases through query process. Contributes to the implementation of new intake-related systems, processes and procedures within the process. Supports an engaging culture. Ensures quality of PC, AE and OSF records. Applies analytical skills to evaluate moderately complex situations using multiple sources of information while applying multiple systems. Implements Standard Operating Procedure requirements for device/combination product cases. Develops solutions to technical problems up to moderate complexity. Knowledge and Skills: Understanding of the applicable global regulatory requirements (Good Manufacturing Practices, Good Pharmacovigilance Practices). Familiarity with clinical development process. Demonstrating high case level productivity and quality. Attention to detail. Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree and 4 years of Drug Safety or Life Sciences experience OR Master s degree and 7 years of Drug Safety or Life Sciences experience OR Bachelor s degree and 9 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.

Let s do this. Let s change the world. In this vital role you will join a collaborative team implementing and supporting the next generation of safety platforms and supporting technologies. In this role, you will focus on solving and resolving daily issues related to processing of data and files related to adverse events across multiple systems for case transmissions. Youll collaborate with others to ensure smooth data flow and quickly address problems, using your analytical skills to keep systems running efficiently. Roles & Responsibilities: Supervise daily data processes to identify and resolve issues where files are delayed or stuck. Tackle system and data reconciliation issues, collaborating with teams to resolve root causes and implement solutions. Work with various internal and external teams to address system dependencies and mitigate bottlenecks. Document and maintain records of recurring issues, proposed fixes, and preventive measures to improve process reliability. Collaborate with stakeholders to provide updates and ensure visibility in issue resolution. Develop and refine dashboards or reports to track system performance and file flow metrics. Participate in regular team meetings to discuss challenges, insights, and recommendations for process improvement. Responsible for ensuring that data is adhering to the KCI metrics on a regular basis Develop and implement test plans, scripts to validate system updates, patches and new deployments Identify and document system bugs or discrepancies, collaborating with developers or vendors to resolve them. Perform regression testing to ensure updates or fixes do not negatively impact existing functionalities. Automate repetitive testing processes and improve testing efficiency. 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 0 to 3 years of Life Science / Biotechnology / Pharmacology / Information Systems experience Or Diploma and 4 to 7 years of Life Science / Biotechnology / Pharmacology / Information Systems experience Preferred Qualifications: Must-Have Skills Strong analytical and problem-solving skills to diagnose and resolve system-related issues. Experience with data transfer processes and tackle stuck or delayed data files. Knowledge of testing methodologies and quality assurance standard processes. Proficiency in working with data analysis and QA tools. Knowledge of Validation of systems Good-to-Have Skills: Experience in Pharmacovigilance systems Experience with Signal or Risk Management platforms is a plus Knowledge or some experience in database programming languages such as Oracle SQL and PL/SQL Outstanding written and verbal communication skills, and ability to explain technical concepts to non-technical clients Sharp learning agility, problem solving and analytical thinking Knowledgeable in SDLC, including requirements, design, testing, data analysis, change control Professional Certifications (please mention if the certification is preferred or mandatory for the role): SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work Excellent analytical and gap/fit assessment skills 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 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. 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.