1738 Pharmacovigilance Jobs - Page 27

PV Supervisor ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Supervisor, Pharmacovigilance to join our diverse and dynamic team. As a Supervisor, Pharmacovigilance at ICON, you will play a pivotal role in overseeing the safety monitoring and reporting of adverse events related to clinical trials and marketed products. You will contribute to ensuring patient safety and regulatory compliance through effective management of pharmacovigilance activities, coordination with cross-functional teams, and maintaining the highest standards of safety reporting. Roles & Responsibilities: The Supervisor Pharmacovigilance supervises a subordinated group and oversees the related tasks. The Supervisor Pharmacovigilance supports creation and updates of SOPs, participates in departmental process and system improvement initiatives. Reviews project tasks performed by the group and provides leadership in the delivery of related services to clients. Is actively working on the tasks the subordinated job role performs as per the respective job description. Supervises case workflow. Assists or provides oversight with organization and planning of meetings, including preparation and distribution of presentations, agendas, and meeting minutes, as requested. Ensure adequate maintenance of SAE Hot Line, and other departmental phone lines, including documenting contacts and submitting to appropriate personnel. Recommends and supports implementation of performance and productivity improvements within the assigned service area to ensure optimal utilization of billable staff. Performs metric collection and data analysis to support company efforts for continuous improvement in policies, procedures, and business processes. Identifies and implements process improvements through review of SOPs, processes and recommends improvement plans to senior management. Participates in task forces to implement process improvement initiatives. Builds teamwork and improves process and productivity by working within and across functional areas. Creates an environment that encourages learning, self-improvement and career development for staff. Supports the development and implementation of training for the subordinated group or other personnel within the assigned service area. Supports direct reports and senior management during audit preparation and conduct. Responds to audit findings as needed. Develops company employees to ensure high quality work performance and retention of high-quality employees. Ensures staff development and performance feedback are provided through activities such as mentorship and career development. Communicates team/individual goals and expectations to ensure direct reports understand their responsibilities. Involved in the recruiting processes for new employees within the assigned service area. May serve as Local/Qualified Person for Pharmacovigilance (including deputy level). Supervision Given Directly supervises support-level staff and/or entry level professionals. Work is done independently and reviewed at critical points. What You Will Be Doing: Supervising the day-to-day pharmacovigilance operations, ensuring timely and accurate reporting of adverse events. Collaborating with cross-functional teams, including clinical operations and regulatory affairs, to optimize pharmacovigilance processes. Ensuring compliance with global regulatory requirements and internal standard operating procedures for safety reporting. Managing safety data collection, analysis, and submission to regulatory authorities. Providing leadership and training to the pharmacovigilance team, ensuring adherence to best practices in safety monitoring. Your Profile: Bachelor s degree in life sciences, pharmacy, or a related field. Experience in pharmacovigilance or drug safety, with a focus on clinical trials or post-marketing surveillance. Strong knowledge of global pharmacovigilance regulations and guidelines. Excellent communication, leadership, and organizational skills, with the ability to manage a team effectively. Detail-oriented with the ability to manage multiple tasks and ensure accuracy in safety reporting. What ICON can offer you: Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Elanco is looking for Analyst - Pharmacovigilance to join our dynamic team and embark on a rewarding career journey Monitor and report adverse drug reactions (ADRs) Ensure compliance with global PV regulations Analyze case reports and maintain safety databases Support audits and regulatory submissions

Novo Nordisk Global Business Solutions (GBS) India Department – Centralised Monitoring Unit (CMU) Does your motivation come from challenges and working in a dynamic environmentDo you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essentialDo you have a can-do attitude with continuous improvement as one of your career objectivesThen we might have the right position for you. Apply now and join a growing team, working in an international environment. About the department The Centralised Monitoring Unit (CMU)- Bangalore, is a department within the Clinical Drug Development area. It is a perfect blend of skilled medical professionals (Medical reviewers) and technical programmers (Functional programmers, statistical monitors). Medical reviewers are actively involved in Risk-based medical monitoring in collaboration with the medical specialists from Denmark, with a focus on ensuring overall patient safety and wellbeing of all clinical trial participants, by ensuring compliance to protocol and identifying potential clinically significant outliers that require medical attention and medical data cleaning. The Functional Programmers develop operational visualizations in data visualization tools to support the trial teams on proactive centralized monitoring and Statistical Monitors perform the detection of unusual data patterns, systematic errors, and potential lack of compliance or fraud across trials. The Position (NoteThis is not a role within Pharmacovigilance) The Senior Medical Reviewer is responsible for conducting comprehensive medical reviews of clinical trial data across various therapy areas within the drug development portfolio. This role ensures the highest quality and consistency of medical data, with a strong emphasis on patient safety, protocol adherence, and compliance with Good Clinical Practice (GCP), ICH guidelines, local regulations, and Standard Operating Procedures (SOPs). Key responsibilities include collaborating closely with study team members—such as Data Managers, Trial Managers, and Medical Specialists—throughout the trial process, providing timely updates on the status of medical reviews, and escalating any issues to maintain trial integrity and compliance. Responsible for contribution to or participation in trial planning activities related to medical review. Perform the quality check measure for the medical review. Responsible for clarifying and if possible, resolving issues of medical concern and inconsistencies in clinical trial data with staff at investigational sites. Responsible for presenting findings of Medical Review to relevant Medical Specialists to enable decision-making. Responsible for documenting medical reviews in the sponsor TMF. Ensure close collaboration with relevant study group members, especially the Data Manager, Trial Manager(s), and Medical Specialist during trial conduct. Provide training on the project and process to the new team members. Review and provide inputs to MMP as well as Medical Monitoring, Displays or other data listing required to perform Medical review. The input should ensure unambiguous monitoring requirements as well as medical monitoring displays and data listing to enable efficient medical review. Qualifications A graduate degree in Medicine or a related field is required (MBBS & MD . MBBS & MD in other clinical areas with relevant experience in clinical patient management or clinical research will also be considered. Preferably above 3 years of relevant experience in Clinical Drug Development (Medical Data Review, Medical Monitoring, Investigator, Safety Surveillance, Scientific Clinical Drug Development etc). 1-2 years of project management experience is essential. Solid understanding of ICH (International Council for Harmonisation) guidelines and GCP (Good Clinical Practice) principles. Proficient in computer applications, including MS Office, MS Project, and PowerPoint. Strong grasp of medical terminology and clinical trial processes. Demonstrated analytical skills with a results-oriented approach. Exceptional proficiency in written and spoken English.

Novo Nordisk Global Business Solutions (GBS) India Department – Centralised Monitoring Unit (CMU) Does your motivation come from challenges and working in a dynamic environmentDo you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essentialDo you have a can-do attitude with continuous improvement as one of your career objectivesThen we might have the right position for you. Apply now and join a growing team, working in an international environment. About the department The Centralised Monitoring Unit (CMU)- Bangalore, is a department within the Clinical Drug Development area. It is a perfect blend of skilled medical professionals (Medical reviewers) and technical programmers (Functional programmers, statistical monitors). Medical reviewers are actively involved in Risk-based medical monitoring in collaboration with the medical specialists from Denmark, with a focus on ensuring overall patient safety and wellbeing of all clinical trial participants, by ensuring compliance to protocol and identifying potential clinically significant outliers that require medical attention and medical data cleaning. The Functional Programmers develop operational visualizations in data visualization tools to support the trial teams on proactive centralized monitoring and Statistical Monitors perform the detection of unusual data patterns, systematic errors, and potential lack of compliance or fraud across trials. The Position (NoteThis is not a role within Pharmacovigilance) The Medical Reviewer is responsible for conducting comprehensive medical reviews of clinical trial data across various therapy areas within the drug development portfolio. This role ensures the highest quality and consistency of medical data, with a strong emphasis on patient safety, protocol adherence, and compliance with Good Clinical Practice (GCP), ICH guidelines, local regulations, and Standard Operating Procedures (SOPs). Key responsibilities include collaborating closely with study team members—such as Data Managers, Trial Managers, and Medical Specialists—throughout the trial process, providing timely updates on the status of medical reviews, and escalating any issues to maintain trial integrity and compliance. Responsible for contribution to or participation in trial planning activities related to medical review. Perform the quality check measure for the medical review. Responsible for clarifying and if possible, resolving issues of medical concern and inconsistencies in clinical trial data with staff at investigational sites. Responsible for presenting findings of Medical Review to relevant Medical Specialists to enable decision-making. Responsible for documenting medical reviews in the sponsor TMF. Ensure close collaboration with relevant study group members, especially the Data Manager, Trial Manager(s), and Medical Specialist during trial conduct. Provide training on the project and process to the new team members. Review and provide inputs to MMP as well as Medical Monitoring, Displays or other data listing required to perform Medical review. The input should ensure unambiguous monitoring requirements as well as medical monitoring displays and data listing to enable efficient medical review. Qualifications A graduate degree in Medicine or a related field is required (MBBS & MD . MBBS & MD in other clinical areas with relevant experience in clinical patient management or clinical research will also be considered. Preferably above 3 years of relevant experience in Clinical Drug Development (Medical Data Review, Medical Monitoring, Investigator, Safety Surveillance, Scientific Clinical Drug Development etc). 1-2 years of project management experience is essential. Solid understanding of ICH (International Council for Harmonisation) guidelines and GCP (Good Clinical Practice) principles. Proficient in computer applications, including MS Office, MS Project, and PowerPoint. Strong grasp of medical terminology and clinical trial processes. Demonstrated analytical skills with a results-oriented approach. Exceptional proficiency in written and spoken English.

Novo Nordisk Global Business Solutions (GBS) India Department – Centralised Monitoring Unit (CMU) Does your motivation come from challenges and working in a dynamic environmentDo you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essentialDo you have a can-do attitude with continuous improvement as one of your career objectivesThen we might have the right position for you. Apply now and join a growing team, working in an international environment. About the department The Centralised Monitoring Unit (CMU)- Bangalore, is a department within the Clinical Drug Development area. It is a perfect blend of skilled medical professionals (Medical reviewers) and technical programmers (Functional programmers, statistical monitors). Medical reviewers are actively involved in Risk-based medical monitoring in collaboration with the medical specialists from Denmark, with a focus on ensuring overall patient safety and wellbeing of all clinical trial participants, by ensuring compliance to protocol and identifying potential clinically significant outliers that require medical attention and medical data cleaning. The Functional Programmers develop operational visualizations in data visualization tools to support the trial teams on proactive centralized monitoring and Statistical Monitors perform the detection of unusual data patterns, systematic errors, and potential lack of compliance or fraud across trials. The Position (NoteThis is not a role within Pharmacovigilance) The Associate Medical Reviewer is responsible for conducting comprehensive medical reviews of clinical trial data across various therapy areas within the drug development portfolio. This role ensures the highest quality and consistency of medical data, with a strong emphasis on patient safety, protocol adherence, and compliance with Good Clinical Practice (GCP), ICH guidelines, local regulations, and Standard Operating Procedures (SOPs). Key responsibilities include collaborating closely with study team members—such as Data Managers, Trial Managers, and Medical Specialists—throughout the trial process, providing timely updates on the status of medical reviews, and escalating any issues to maintain trial integrity and compliance. Responsible for contribution to or participation in trial planning activities related to medical review. Perform the quality check measure for the medical review. Responsible for clarifying and if possible, resolving issues of medical concern and inconsistencies in clinical trial data with staff at investigational sites. Responsible for presenting findings of Medical Review to relevant Medical Specialists to enable decision-making. Responsible for documenting medical reviews in the sponsor TMF. Ensure close collaboration with relevant study group members, especially the Data Manager, Trial Manager(s), and Medical Specialist during trial conduct. Provide training on the project and process to the new team members. Review and provide inputs to MMP as well as Medical Monitoring, Displays or other data listing required to perform Medical review. The input should ensure unambiguous monitoring requirements as well as medical monitoring displays and data listing to enable efficient medical review. Qualifications A graduate degree in Medicine is required.Candidates with an MBBS or MD in other clinical specialties, along with relevant experience in clinical patient management or clinical research, will be considered. Preferably above 1 years of relevant experience in Clinical Drug Development (Medical Data Review, Medical Monitoring, Investigator, Safety Surveillance, Scientific Clinical Drug Development etc). 1-2 years of project management experience is essential. Solid understanding of ICH (International Council for Harmonisation) guidelines and GCP (Good Clinical Practice) principles. Proficient in computer applications, including MS Office, MS Project, and PowerPoint. Strong grasp of medical terminology and clinical trial processes. Demonstrated analytical skills with a results-oriented approach. Exceptional proficiency in written and spoken English.

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

Career Category 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 .

Career Category Safety Job Description 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 .

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. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers. amgen. com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. .

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. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers. amgen. com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. .

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. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers. amgen. com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. .

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We re driven by our vision of Food and Companionship Enriching Life and our approach to sustainability - the Elanco Healthy Purpose - to advance the health of animals, people, the planet and our enterprise. Making animals lives better makes life better - join our team today! Roles and Responsibilities: Prepare aggregate reports to meet submission timelines in accordance with defined processes. Performs proof reading of the self-authored documents before Quality Check reviews. Perform literature searches, sales data extraction and line listing generations in accordance with defined processes. Works effectively and flexibly within and across all Elanco Regulatory/R&D teams and external collaborators to achieve overall Elanco Regulatory/R&D deliverables. Comply with and support group management tools, standards, policies and initiatives. Maintains Veeva Vault RIM activities and complete all the tasks on time. Maintains audit, SOP and training compliance. Performs additional tasks to support Global Pharmacovigilance as assigned. Minimum Qualification (education, experience and/or training, required certifications): Graduation in veterinary medicine, post-graduation in pharmacy or any other life science background with minimum 3 years of industry experience in PV or medical writing. Excellent oral and written communication skills with ability to communicate logically and technically with global team members. High competency in Microsoft Office applications. Strong GxP knowledge, in particular GCP, cGMP, GLP. In-depth knowledge of GxP requirements and regulatory guidelines with sound understanding of operational Regulatory and R&D principles. Ability to work independently or as part of a team and collaborate with global teams across geographies and time zones. Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

Job Title: Manager- 1/Manager- 2 Job Category: Permanent Department/Group: R&D IT/Project Job Code/ Req#: NA Location: Baroda Travel Required: No Level/Salary Range: G10 Position Type: FTE Contact: NA Date Posted: June-25 Will Train Applicant(s): NA Posting Expires: NA External Posting URL: NA Internal Posting URL: NA Job Summary Application support and lead will be responsible for the successful implementation of assigned projects. This role requires a deep understanding of Argus application and Pharmacovigilance area. Understanding in AI/ML, Artwork management is preferred. Job Description Role and Responsibilities Argus upgrade application implementation support for PVG department AMS (Artwork Management System) upgrade and enhancements Support in AI/ML initiatives Execute the tasks defined in project plans, adhering to timelines, for successful implementation of assigned projects and activities Managing QMS Shall support internal/external audits and draft audit response, as needed Qualifications and Preference Qualifications Bachelors degree in Information Technology, or Computer Science or related field. Minimum of 5-7 years of experience in application support, preferably PVG domain Ability to manage multiple tasks and projects simultaneously. Strong analytical and problem-solving skills. Excellent communication and interpersonal skills. Preferred Qualifications AI/ML development Oracle Argus Data processing and engineering Troubleshooting and problem-solving Familiarity with Big Data Technologies Performing Statistical Analysis Reviewed By: Date: Approved By: Date: Last Updated By: Date/Time:

Greetings From Sri Sai Medicode Certified Freshers For IPDRG Any Certification/ Non Certified Also Life Science Graduates Only Training After Placement WhatsApp - 63057 88230 SRI SAI MEDICODE - KPHB HYDERABAD https://ssmedicode.com/

We are looking for a highly skilled and experienced Analyst to join our team in the IT Services & Consulting industry. The ideal candidate will have 6-9 years of experience in KYC analysis. Roles and Responsibility Conduct thorough analysis of customer data to identify potential risks and ensure compliance with regulatory requirements. Develop and implement effective risk management strategies to mitigate identified risks. Collaborate with cross-functional teams to resolve complex issues and improve overall process efficiency. Provide expert guidance on KYC procedures and best practices to junior team members. Stay up-to-date with industry trends and regulatory changes to ensure the organization's compliance. Perform regular audits to ensure adherence to established policies and procedures. Job Requirements Strong understanding of KYC regulations and industry standards. Excellent analytical and problem-solving skills with attention to detail. Ability to work effectively in a fast-paced environment and meet deadlines. Effective communication and interpersonal skills, with the ability to collaborate with diverse stakeholders. Strong knowledge of financial services industry operations and regulations. Experience with risk management frameworks and methodologies.

We are looking for a skilled Associate Process Manager to join our team at eClerx Services Ltd., responsible for managing the KYC process. The ideal candidate will have a strong background in IT Services & Consulting, with excellent leadership and management skills. Roles and Responsibility Manage and oversee the KYC process to ensure compliance with regulatory requirements. Develop and implement process improvements to increase efficiency and reduce costs. Collaborate with cross-functional teams to identify and mitigate risks. Analyze data and metrics to optimize processes and improve customer satisfaction. Train and guide team members on new processes and procedures. Monitor and report on key performance indicators to senior management. Job Requirements Minimum 5 years of experience in a related field, preferably in IT Services & Consulting. Strong knowledge of KYC regulations and industry standards. Excellent communication, leadership, and problem-solving skills. Ability to work in a fast-paced environment and meet deadlines. Strong analytical and decision-making skills. Experience with process improvement initiatives and change management. Ref number: 6584935.

Summary The Group Lead, Medical Safety Operations (MSO), is responsible for managing a group of Medical Safety Experts (MSE) and Senior Medical Safety Experts (Sr MSE) within MSO. This is accomplished by organizing and planning of the deliverables of the Team. He/she may keep an oversight of all outsourced activity for Medical Safety function. Acts as point of contact for global Medical Safety for the External Service Providers (ESPs) performing outsourced activities. Leads and supports projects that are within the scope of medical safety operations. The Group Lead is also responsible for the development and implementation of: Enhanced medical safety quality processes and procedures. Enhanced line function excellence and standards. About the Role Major accountabilities: Manage a group of MSE & Sr MSE within the MSA&EE. Ensure that their deliverables are met according to the agreed standards and timelines. Ensure and drive compliance & quality of deliverables to consistently high standards. Participate in the MSA&EE management strategy and operational plan. Ensures optimal communication and feedback between the Therapeutic Areas and the Medical Safety Experts. Support the Head of Med Safety Assessment & ESP Engagement in soliciting and forecasting future requirements for the MSA&EE. Participate in organizing and planning the work of the MSE & Sr MSE as per Therapeutic area aggregate reports and other documents schedule and ad-hoc urgent activities i.e. Health Authority Requests. Liaise with the Head Patients Safety and Global Program Safety Leads to get feedback on the performance of the MSE & Sr MSE and ensure that adequate training is put in place accordingly. Is responsible for overall training and career development planning for the team MSO. Develops effective relationships with internal and external stakeholders to ensure successful outcomes of objectives. Participate in analyzing the workload of the Team based on a detailed Work-Unit assessment. Liaise, support, and represent the MSA&EE during Audits and Inspections undertaken at PS&PV. Cross functionally collaborates with other work teams of PS&PV and represent MSA&EE in common forums. Contribute to the MSA&EE resource planning. Build a high performing group of MSE & Sr MSE and recruit, retain and develop best talent; assess resource needs on a regular basis to achieve ongoing process improvements, to provide sufficient process excellence support and to create/maintain a sustainable compliance culture. Keeps an oversight of all applicable outsourced activities related to medical function. Acts as point of contact for global Medical Safety for questions related to outsourced activity. Supports quality and compliance lead to ensure quality and compliance of all outsourced activities. Ensure transparent and clear communications with ESPs. Participate in applicable ESP governance meetings. Collaborate with the ESPs and provide trainings as necessary. Support onboarding and training activities within Medical Safety. Ensures completion of all MRQC arbitrations in timely manner from ESPs. Ensure timely completion of scores for OSCM related to medical function. Work in close collaboration with Head of Med Safety Assessment & ESP Engagement for early identification of issues related to ESPs. Represents Medical Safety in cross-functional and/or cross-departmental initiatives which aim to improve processes and ensure a quality and compliance focused environment either by direct involvement or by ensuring appropriate Line Function representation. Collaborates with PS&PV QA and Global Development Clinical Quality and supports the implementation of the Pharmacovigilance Quality Plan. Tracks, reports and follows-up to completion all Corrective Actions and Preventative Actions (CAPA) identified during audits and inspections. Identifies, manages and reports on Medical Safety Key Quality Indicators. Recommends corrective actions and ensures all relevant follow-up activities are completed based upon report outputs. Ensures compliance to and supports adequate training opportunities for new SOPs and Business Guidance. In collaboration with LF and QA, ensures individuals comply with Novartis PV processes. Tracks deviations from SOPs in Novartis QMS and in collaboration with QPPV office and PV compliance department, ensures appropriate documentation is filed and corrective actions are taken. Provides backup support for the Head of Med Safety Assessment & ESP Engagement. Key Performance Indicators (indicate how performance for this role will be measured) Efficiency of MSA&EE Team management and support underlined by delivery of high-quality activities/tasks to the therapeutic areas. Quality of the liaison between the MSA&EE and the Therapeutic Areas for work planning organization. Timeliness, quality, and efficiency of the results obtained through targeted training for the Team, Efficient strategy of the activity/task planning for the MSA&EE under responsibility in the Therapeutic Areas. Recruitment, retention and development of talents in the MSA&EE. Finalization of all scores related to medical function (ICSR and PSUR) well within timelines. Health Authority Inspections and internal audits have no critical findings related to the Medical Safety function accountabilities in particular for quality and regulatory compliance due to medical function. Successful implementation of improvements as measured by sustainable changes and improved efficiency. Creative & innovative thinking for operational excellence, best practices and lessons learned. Job Dimensions (Indicate key facts and figures) Number of associates: Up to 15 associates (direct reports) Financial responsibility: (Budget, Cost, Sales, etc.) Participation to the medical Safety operations resource planning. Impact on the organization: Scheduling and management of the Medical Safety Operations work in the different MSO circles. Cooperation between the Medical Safety operations and the medical function for work planning organization and efficiency of deliverables. Ideal Background: Education: Advanced degree or equivalent education/degree in life science/healthcare. MD, MBBS, PharmD, PhD preferred. Language: Fluent in spoken and written English. Experience : Required professional experience: 8 years in drug development in a major pharmaceutical company (of which 3 are in a global position in safety/clinical/medical affairs or other relevant line function at an operational or medical position) Demonstrated people management experience (direct/matrix). Strong leadership and people management skills, with ability to successfully lead, engage and develop a highly effective team. Excellent negotiation, conflict resolution, decision making, problem solving, communication (written and verbal) and presentation skills Results driven, self-starter with proactive working style, committed and accountable, transparent working style also under pressure. Quality oriented. Good planning, organizational and computer skills. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Division Development Business Unit Innovative Medicines Location India Site Hyderabad (Office) Company / Legal Entity IN10 (FCRS = IN010) Novartis Healthcare Private Limited Functional Area Research & Development Job Type Full time Employment Type Regular Shift Work No Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Pharmacovigilance Internship with Stipend For Pharmacy Life Sciences Medical & Paramedical Should have Pharmacovigilance Certification Good knowledge in Clinical Research Pharmacovigilance and MedDRA Required Candidate profile B.Pharm M.Pharm and Pharm D who are passionate to learn hands on Experience on Softwares and For Job Seekers ready to relocate can be Applicable for this Internship program

Key Responsibilities Pharmaceutical Sales and Promotion Promote and sell allopathic pharmaceutical products to healthcare providers including GPs, hospital doctors, and specialists across Sonipat district Make presentations to doctors, practice staff, and nurses in GP surgeries, hospital settings, and retail pharmacies Act as key link between pharmaceutical companies and healthcare professionals Doctor Network Management Leverage existing strong network of doctors in Sonipat district to drive product adoption and prescription generation Arrange appointments with doctors, pharmacists, and hospital medical teams through established relationships Build and maintain positive working relationships with medical staff and support administrative personnel Territory Management Manage assigned territory effectively with focus on maximizing coverage and sales penetration Conduct retail chemist prescription audit (RCPA) to analyze business dynamics of competitive brands Monitor prescription patterns and provide feedback to company on market dynamics and competitor activities Professional Development and Compliance Stay updated with latest therapeutic developments, drug classifications, and pharmacovigilance requirements Ensure compliance with pharmaceutical marketing guidelines and ethical practices Organize medical conferences and promotional events for healthcare professionals Job Type: Full-time Pay: ₹19,503.70 - ₹75,336.50 per month Schedule: Day shift Monday to Friday Work Location: In person

Title: R&D IT Manager Date: Jun 30, 2025 Location: Gurgaon - Office Company: Sun Pharmaceutical Industries Ltd Job Title: Manager- 1/Manager- 2 Job Category: Permanent Department/Group: R&D IT/Project Job Code/ Req#: NA Location: Baroda Travel Required: No Level/Salary Range: G10 Position Type: FTE Contact: NA Date Posted: June-25 Will Train Applicant(s): NA Posting Expires: NA External Posting URL: NA Internal Posting URL: NA Job Summary Application support and lead will be responsible for the successful implementation of assigned projects. This role requires a deep understanding of Argus application and Pharmacovigilance area. Understanding in AI/ML, Artwork management is preferred. Job Description Role and Responsibilities Argus upgrade application implementation support for PVG department AMS (Artwork Management System) upgrade and enhancements Support in AI/ML initiatives Execute the tasks defined in project plans, adhering to timelines, for successful implementation of assigned projects and activities Managing QMS Shall support internal/external audits and draft audit response, as needed Qualifications and Preference Qualifications Bachelor's degree in Information Technology, or Computer Science or related field. Minimum of 5-7 years of experience in application support, preferably PVG domain Ability to manage multiple tasks and projects simultaneously. Strong analytical and problem-solving skills. Excellent communication and interpersonal skills. Preferred Qualifications AI/ML development Oracle Argus Data processing and engineering Troubleshooting and problem-solving Familiarity with Big Data Technologies Performing Statistical Analysis Reviewed By: Date: Approved By: Date: Last Updated By: Date/Time:

PV Supervisor ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Supervisor, Pharmacovigilance to join our diverse and dynamic team. As a Supervisor, Pharmacovigilance at ICON, you will play a pivotal role in overseeing the safety monitoring and reporting of adverse events related to clinical trials and marketed products. You will contribute to ensuring patient safety and regulatory compliance through effective management of pharmacovigilance activities, coordination with cross-functional teams, and maintaining the highest standards of safety reporting. Roles & Responsibilities: The Supervisor Pharmacovigilance supervises a subordinated group and oversees the related tasks. The Supervisor Pharmacovigilance supports creation and updates of SOPs, participates in departmental process and system improvement initiatives. Reviews project tasks performed by the group and provides leadership in the delivery of related services to clients. Is actively working on the tasks the subordinated job role performs as per the respective job description. Supervises case workflow. Assists or provides oversight with organization and planning of meetings, including preparation and distribution of presentations, agendas, and meeting minutes, as requested. Ensure adequate maintenance of SAE Hot Line, and other departmental phone lines, including documenting contacts and submitting to appropriate personnel. Recommends and supports implementation of performance and productivity improvements within the assigned service area to ensure optimal utilization of billable staff. Performs metric collection and data analysis to support company efforts for continuous improvement in policies, procedures, and business processes. Identifies and implements process improvements through review of SOPs, processes and recommends improvement plans to senior management. Participates in task forces to implement process improvement initiatives. Builds teamwork and improves process and productivity by working within and across functional areas. Creates an environment that encourages learning, self-improvement and career development for staff. Supports the development and implementation of training for the subordinated group or other personnel within the assigned service area. Supports direct reports and senior management during audit preparation and conduct. Responds to audit findings as needed. Develops company employees to ensure high quality work performance and retention of high-quality employees. Ensures staff development and performance feedback are provided through activities such as mentorship and career development. Communicates team/individual goals and expectations to ensure direct reports understand their responsibilities. Involved in the recruiting processes for new employees within the assigned service area. May serve as Local/Qualified Person for Pharmacovigilance (including deputy level). Supervision Given Directly supervises support-level staff and/or entry level professionals. Work is done independently and reviewed at critical points. What You Will Be Doing: Supervising the day-to-day pharmacovigilance operations, ensuring timely and accurate reporting of adverse events. Collaborating with cross-functional teams, including clinical operations and regulatory affairs, to optimize pharmacovigilance processes. Ensuring compliance with global regulatory requirements and internal standard operating procedures for safety reporting. Managing safety data collection, analysis, and submission to regulatory authorities. Providing leadership and training to the pharmacovigilance team, ensuring adherence to best practices in safety monitoring. Your Profile: Bachelor’s degree in life sciences, pharmacy, or a related field. Experience in pharmacovigilance or drug safety, with a focus on clinical trials or post-marketing surveillance. Strong knowledge of global pharmacovigilance regulations and guidelines. Excellent communication, leadership, and organizational skills, with the ability to manage a team effectively. Detail-oriented with the ability to manage multiple tasks and ensure accuracy in safety reporting. What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Summary The Group Lead, Medical Safety Operations (MSO), is responsible for managing a group of Medical Safety Experts (MSE) and Senior Medical Safety Experts (Sr MSE) within MSO. This is accomplished by organizing and planning of the deliverables of the Team. He/she may keep an oversight of all outsourced activity for Medical Safety function. Acts as point of contact for global Medical Safety for the External Service Providers (ESPs) performing outsourced activities. Leads and supports projects that are within the scope of medical safety operations. The Group Lead is also responsible for the development and implementation of: Enhanced medical safety quality processes and procedures. Enhanced line function excellence and standards. About The Role Major accountabilities: Manage a group of MSE & Sr MSE within the MSA&EE. Ensure that their deliverables are met according to the agreed standards and timelines. Ensure and drive compliance & quality of deliverables to consistently high standards. Participate in the MSA&EE management strategy and operational plan. Ensures optimal communication and feedback between the Therapeutic Areas and the Medical Safety Experts. Support the Head of Med Safety Assessment & ESP Engagement in soliciting and forecasting future requirements for the MSA&EE. Participate in organizing and planning the work of the MSE & Sr MSE as per Therapeutic area aggregate reports and other documents schedule and ad-hoc urgent activities i.e. Health Authority Requests. Liaise with the Head Patients Safety and Global Program Safety Leads to get feedback on the performance of the MSE & Sr MSE and ensure that adequate training is put in place accordingly. Is responsible for overall training and career development planning for the team MSO. Develops effective relationships with internal and external stakeholders to ensure successful outcomes of objectives. Participate in analyzing the workload of the Team based on a detailed Work-Unit assessment. Liaise, support, and represent the MSA&EE during Audits and Inspections undertaken at PS&PV. Cross functionally collaborates with other work teams of PS&PV and represent MSA&EE in common forums. Contribute to the MSA&EE resource planning. Build a high performing group of MSE & Sr MSE and recruit, retain and develop best talent; assess resource needs on a regular basis to achieve ongoing process improvements, to provide sufficient process excellence support and to create/maintain a sustainable compliance culture. Keeps an oversight of all applicable outsourced activities related to medical function. Acts as point of contact for global Medical Safety for questions related to outsourced activity. Supports quality and compliance lead to ensure quality and compliance of all outsourced activities. Ensure transparent and clear communications with ESPs. Participate in applicable ESP governance meetings. Collaborate with the ESPs and provide trainings as necessary. Support onboarding and training activities within Medical Safety. Ensures completion of all MRQC arbitrations in timely manner from ESPs. Ensure timely completion of scores for OSCM related to medical function. Work in close collaboration with Head of Med Safety Assessment & ESP Engagement for early identification of issues related to ESPs. Represents Medical Safety in cross-functional and/or cross-departmental initiatives which aim to improve processes and ensure a quality and compliance focused environment either by direct involvement or by ensuring appropriate Line Function representation. Collaborates with PS&PV QA and Global Development Clinical Quality and supports the implementation of the Pharmacovigilance Quality Plan. Tracks, reports and follows-up to completion all Corrective Actions and Preventative Actions (CAPA) identified during audits and inspections. Identifies, manages and reports on Medical Safety Key Quality Indicators. Recommends corrective actions and ensures all relevant follow-up activities are completed based upon report outputs. Ensures compliance to and supports adequate training opportunities for new SOPs and Business Guidance. In collaboration with LF and QA, ensures individuals comply with Novartis PV processes. Tracks deviations from SOPs in Novartis QMS and in collaboration with QPPV office and PV compliance department, ensures appropriate documentation is filed and corrective actions are taken. Provides backup support for the Head of Med Safety Assessment & ESP Engagement. Key Performance Indicators (indicate how performance for this role will be measured) Efficiency of MSA&EE Team management and support underlined by delivery of high-quality activities/tasks to the therapeutic areas. Quality of the liaison between the MSA&EE and the Therapeutic Areas for work planning organization. Timeliness, quality, and efficiency of the results obtained through targeted training for the Team, Efficient strategy of the activity/task planning for the MSA&EE under responsibility in the Therapeutic Areas. Recruitment, retention and development of talents in the MSA&EE. Finalization of all scores related to medical function (ICSR and PSUR) well within timelines. Health Authority Inspections and internal audits have no critical findings related to the Medical Safety function accountabilities in particular for quality and regulatory compliance due to medical function. Successful implementation of improvements as measured by sustainable changes and improved efficiency. Creative & innovative thinking for operational excellence, best practices and lessons learned. Job Dimensions (Indicate key facts and figures) Number Of Associates Up to 15 associates (direct reports) Financial Responsibility (Budget, Cost, Sales, etc.) Participation to the medical Safety operations resource planning. Impact On The Organization Scheduling and management of the Medical Safety Operations work in the different MSO circles. Cooperation between the Medical Safety operations and the medical function for work planning organization and efficiency of deliverables. Ideal Background Education: Advanced degree or equivalent education/degree in life science/healthcare. MD, MBBS, PharmD, PhD preferred. Language: Fluent in spoken and written English. Experience Required professional experience: 8 years in drug development in a major pharmaceutical company (of which 3 are in a global position in safety/clinical/medical affairs or other relevant line function at an operational or medical position) Demonstrated people management experience (direct/matrix). Strong leadership and people management skills, with ability to successfully lead, engage and develop a highly effective team. Excellent negotiation, conflict resolution, decision making, problem solving, communication (written and verbal) and presentation skills Results driven, self-starter with proactive working style, committed and accountable, transparent working style also under pressure. Quality oriented. Good planning, organizational and computer skills. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Domnic Lewis has been mandated to hire a Regional Medical Advisor for a leading Pharmaceutical company Regional Medical Advisor Job Description / Capsule Field based scientific experts in assigned therapeutic area that is responsible in the execution of the Medical Affairs Plan(s) for pre-launch and/or newly launched products/indications. Shapes clinical practice through scientific engagements, partnerships and collaborations with traditional (e.g Specialist KEEs for MSLs & Primary Care Physicians for CSLs), and where appropriate non-traditional (e.g. policy and decision makers, PAGs, government, innovative solution providers) experts, as well as, with internal stakeholders to drive enhanced patient outcomes and the safe and effective use of Client medicines.Developing and enhancing professional relationships and partnerships with healthcare professionals and other healthcare ecosystem stakeholders according to the Integrated Engagement Plan. Provides scientific, technical, and pharmaco- economic information to HCPs and key stakeholders through one-on-one discussions and medically lead meetings as experts and confidence generation activities. Can be involved and may lead evidence generation activities as part of the implementation of the medical strategy. Acts as catalysts, with a deep understanding of the health system (environment, priorities, clinical pathways, patient journeys) and its challenges, to gather insights and execute according to the medical strategic plans to deliver strategic, scalable & sustainable clinical practice transformations, enhancing access to equitable quality care for patients and enabling the adoption of our innovative medicines. Scientific Expertise: Maintain clinical/scientific expertise in disease state management, Client products, emerging therapies, and the competitive landscape. Contribute to the development and provide project leadership/ management of the therapeutic area Field Medical Strategic Plan (FMSP). Act as a subject matter expert/resource for internal and external stakeholders. Work with internal stakeholders in the development and delivery of appropriate training and mentoring needs within therapeutic area. Scientific Exchange: Engage in peer-to-peer level dialogue with key customers and deliver appropriate clinical/scientific content through utilising the correct channel mix, which will differentiate Client products from those of other companies. Respond to unsolicited customer inquiries and provide focused and balanced clinical / scientific information that supports the safe and appropriate use of Client//'s products and services. Provide scientific/clinical support and deliver presentations to internal and external stakeholders. Identify and establish relationships with key customers and other scientific thought leaders for engaging them in ongoing scientific dialogue on Client products and unsolicited discussions about compounds in development. Organize and facilitate scientific events such as MSL events, Symposiums, Scientific Exchanges, Advisory Boards/Expert Panels, non-promotional standalone events, Meet the Professor sessions, etc., with KEEs and HCPs. Prioritize these events based on their relevance in the patient journey for the related disease. Deliver informative lectures at scientific events tailored to healthcare professionals, aligning with the field medical. Customer Insight: · Effectively identify, gather, analyse, synthesise, report and forward relevant new knowledge about the external scientific/medical environments to internal stakeholders · Provide internal stakeholders with actionable items related to medical / product strategy or clinical development based on customer perspectives. · Partner with traditional and non-traditional stakeholders to identify gaps in the patient experience journey as insights to be included in the medical / product strategies. Strategic Relationship: · Develop peer-level relationships with medical and scientific experts, including Healthcare Professionals and collaborate with other internal teams for other key external stakeholders (e.g. policy and decision makers, PAGs, government, innovative solution providers) consistent with Medical objectives. · Identify pre-clinical, clinical, and post-marketing study investigators in alignment with Medical Plans. · Support data generation activities including participating in reviews of Investigator sponsored studies. · Looks to broaden the My MA contact list where appropriate to include non-traditional KEEs from government, payer groups, researchers and clinical advisors who may support practice change initiatives. · Establish win-win partnerships with traditional and non-traditional stakeholders to deliver on strategic, scalable and sustainable solutions addressing patient healthcare access gaps within the ecosystem. Other: · Responsible for leveraging digital and innovation / technology as enablers for scientific exchange and creating patient centric solutions. · Possesses a solid grasp of pharmacovigilance and GxP principles, showcasing a clear understanding of their significance. This includes practical knowledge of Good Clinical Practice (GCP), various types of clinical studies, and requirements for reporting adverse events (AEs). · Possesses a solid grasp of pharmacovigilance and GxP principles, showcasing a clear understanding of their significance. This includes practical knowledge of Good Clinical Practice (GCP), various types of clinical studies, and requirements for reporting adverse events (AEs). · Exhibits a robust understanding of the Ethical Interactions Policy, along with relevant standards, local laws, and regulations. Moreover, possesses the ability to provide training to others in this domain. · Adherence to internal processes and Client Global Field Medical Standards and the external regulations including but not limited to clinical trials, promotional activity (e.g. Local Code of Conduct) and pharmacovigilance activities to meet internal SOP and local regulations. Education, Qualifications, Skills and Experience Essential Scientific and or a master//'s degree in a scientific discipline Excellent oral and written communication and interpersonal skills Ability to communicate internally and externally using the different channel mix. Excellent project management skills Excellent presentation skills High level analytical and conceptual thinking Desirable Doctoral degree in a scientific discipline (e.g. M.D., Ph.D., Pharm.D.) · Experience in pharmaceutical industry, regulatory environment, clinical or preclinical research, and knowledge of a therapeutic area disease state and treatment. Experience with basic research, drug discovery, drug development and KEE interactions.

Planning, organizing and implementing strategies and activities required to procure regulatory approval for new and revised product lines under the guidance of more senior regulatory professionals. Ensuring compliance to all US, EU Required Candidate profile 510(k) and CE Marking; IDE, PMA (original/revision/supplements) preparation a plus Minimum 1-year experience in FDA regulated industry Working knowledge of Medical Device Regulations (FDA and EU)

Key Responsibilities: Liaising with doctors, nurses, and other healthcare professionals to ensure the safe, effective, and economical delivery of drug treatments. Participating in dispensary work, including clinical checks and accuracy checking of prescriptions and dispensed medicines. Ensuring all work complies with Medicines Ethics and Practice, local policies and procedures, risk management, and health and safety protocols. Dispensing and supplying medicines. Receiving, storing, and supplying controlled drugs in accordance with hospital policy. Creating purchase orders (P.O.) and preparing GRNs for the same. Processing purchase returns of medicines due to expiry. Handling narcotics and maintaining proper records. Arranging non-available medicines from nearby chemists. Handing over cash to the cashier. Conducting quarterly stocktaking.