Job description Company Description At 9NEXUS, we provide cutting-edge IT services and strategic offshore staffing solutions. With a strong presence in the UK, we connect businesses with top-tier talent globally to deliver cost-effective and high-quality resources. We pride ourselves on sourcing exceptional IT professionals through a rigorous recruitment process, ensuring the best matches for our clients' needs. Our combination of offshore excellence and onshore support boosts seamless collaboration and local project management. Our client-centric approach and tailored IT staff augmentation solutions cater to diverse industries, delivering quality without compromise. Job Title: Veeva Safety Engineer Experience: 5–4 Years Location: [Remote] Job Type: [Full-Time] Job Summary We are seeking a skilled Veeva Safety / Clinical Engineer with 5years of experience to join our team. The ideal candidate will have hands-on expertise in configuring Veeva Vault Safety and will play a pivotal role in supporting ongoing projects within the pharmacovigilance domain. Veeva Safety: Key Responsibilities Configure and customize Veeva Vault Safety to align with business requirements. Collaborate with cross-functional teams to gather and analyze system requirements. Support the implementation and maintenance of Veeva Safety solutions. Troubleshoot and resolve issues related to Veeva Safety configurations. Required Qualifications Bachelor’s degree in Computer Science, Life Sciences, or a related field. 5–4 years of experience working with Veeva Vault Safety. Proven experience in configuring Veeva Safety modules. Strong understanding of pharmacovigilance processes and regulatory requirements. Excellent problem-solving skills and attention to detail. Preferred Qualifications Veeva Vault Certified Administrator or Veeva Safety Certified Professional. Veeva Clinical: Role title : Veeva Vault Clinical Engineer Experience:5years Bangalore - 2 days office hybrid. Area of expertise: Veeva Vault Clinical – CTMS & eTMF; Veeva Vault CDMS – EDC, Integrations, connections, configuration, Build, enhance, support experience. • Functional knowledge of clinical trials and correlation with clinical systems is added advantage. • Should be able to demonstrate his technical and functional skills • Location: Primarily at Bengaluru, India. Show more Show less

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

Skill required: Life Sciences (AR&D) Services - SDTM Programming Designation: Associate Qualifications: Any Graduation,BE,BTech Years of Experience: 1-3 yrs About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. sdtm programmer Program mapping of eCRF and external data into SDTM standards using SAS/ETL tools as applicable. What are we looking for? sdtm programmer sdtm programmer Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Any Graduation,BE,BTech Show more Show less

Job Title: Product Manager – Life Sciences Location: [Chennai, Bengaluru, Noida] Department: Product Management / Life Sciences Solutions 📝 Job Summary: We are seeking a dynamic and experienced Product Manager – Life Sciences to lead the strategy, planning, and execution of innovative products that serve the pharmaceutical, biotechnology, medical device, and healthcare industries. This individual will drive product lifecycle management from ideation to commercialization, ensuring the delivery of compliant, high-impact solutions that support R&D, clinical development, regulatory, and post-market needs. Candidates should bring strong domain expertise, digital product acumen, and the ability to bridge scientific insight with commercial value. 🧠 Key Responsibilities: 1. Product Strategy & Vision Define and own the product vision, strategy, and roadmap for life sciences offerings (drug development, clinical trials, regulatory, pharmacovigilance, etc.). Conduct market research, customer interviews, and competitive analysis to inform feature prioritization and differentiation. 2. Product Lifecycle Management Manage the full product lifecycle from ideation, MVP development, pilot testing, global rollout, to post-market updates and sunsetting. Lead cross-functional teams through Agile development cycles to deliver high-quality, timely product releases. 3. Stakeholder Collaboration Act as the key interface between engineering, scientific SMEs, marketing, regulatory affairs, and sales. Collaborate with external partners, CROs, regulatory bodies, and key opinion leaders to refine product features and ensure compliance. 4. Innovation & Digital Transformation Drive the integration of emerging technologies such as Gen AI, NLP, RWD/RWE platforms, and cloud-based systems into life sciences workflows. Partner with AI/ML teams to conceptualize smart, compliant features for medical content generation, adverse event detection, clinical data analysis, and signal management. 5. Go-to-Market & Commercialization Develop product launch plans, including value propositions, pricing, positioning, and user training. Support pre-sales and customer success teams with product demos, documentation, and RFP responses. 📋 Required Qualifications: Education: Bachelor’s degree in Life Sciences (Pharmacy, Biology, Biotechnology, or equivalent). Advanced degree (MS, PhD, or MBA) is a plus. Experience: 10+ years of experience in product management within the life sciences, pharmaceutical, biotechnology, or medical devices industry. Demonstrated experience launching B2B SaaS, clinical, regulatory, or pharmacovigilance products in regulated environments. Prior involvement in global product rollouts across multiple markets. Domain Expertise: Strong understanding of clinical trial processes, drug safety, regulatory compliance (GxP, FDA, EMA, ISO 13485), and R&D lifecycle. Experience with HealthTech, MedTech, Genomics, or Real World Evidence (RWE) is highly desirable. Technical & Tools: Familiarity with AI/ML applications in life sciences is a strong advantage. Proficiency with product management tools (JIRA, Aha!, Confluence), wireframing (Figma, Balsamiq), and analytics dashboards. Experience working with cloud (AWS, Azure), API integrations, and GxP-compliant systems. ✅ Preferred Competencies: Strategic thinking with strong analytical and decision-making skills. Excellent communication, storytelling, and stakeholder management abilities. Strong organizational skills and a results-oriented mindset. Comfortable navigating ambiguity in highly regulated industries. Experience working with global teams across time zones. 🎯 KPIs & Success Metrics: Time-to-market for new product/features. Product adoption and customer satisfaction (NPS, CSAT). Revenue growth and market share contribution. Compliance and regulatory approval success rates. Show more Show less

Summary Of Responsibilities Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to: Hands on experience working on clinical trial cases, spontaneous cases, Post marketing solicitate(PMS) and good to have LAM. Data entry of safety data onto adverse event database(s) and tracking systems. Review of adverse events for completeness, accuracy and appropriateness for expedited reporting. Write patient narratives and code adverse events accurately using MedDRA. Determine listedness against appropriate label (for Marketed products, if applicable). Identifies clinically significant information missing from the reports and ensures its collection and follow-up. Ensure all cases that require expediting reporting to worldwide Regulatory Agencies and other required parties are processed swiftly and appropriately within required timelines. Reporting of endpoints to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, if required, within study specified timelines. Submission of expedited Serious Adverse Event (SAE) reports to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, if required and as agreed with client during study set-up, within study specified timelines. Perform Database reconciliation with Data Management team or sponsor/client as needed. Perform processing and/or review and submission of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs), including but not limited to: Maintenance of adverse event tracking systems. Set-up and maintenance of project files and central files for documentation. Assist with the reporting of ESRs and PSRs to clients, Regulatory Authorities, Ethics Committees, investigators and Fortrea project personnel, as required, within study specified timelines. Maintain a strong understanding of Fortrea’s safety database conventions or client specific database conventions, as appropriate. Perform quality review or peer review of processed reports and support the Line Management with trends and actions needed. Begin participating in signal detection and trend and pattern recognition activities, as appropriate. Assist in the preparation of listings for Annual IND reports, Periodic Reports (PRs) like Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs) etc. Begin participating in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided. Support/train/mentor less experienced safety staff in all aspects of case-handling, adverse event reporting. Maintain a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance. Assist with review and update of Safety Management Plans (SMPs), Reconciliation Plans, and other safety- specific plans ensuring optimal efficiency. Participate in Fortrea project team and client meetings, as appropriate. Prepare and support coordination of safety study files for archiving at completion of projects. Contribute to root cause analysis, including the CAPA plan development and implementation. Support Audits and/or inspections preparation. Assist in review of cumulative safety data for submission to Drug Safety Monitoring Boards (DSMBs), regulatory authorities or clients, if applicable and coordination of end point committees. All other duties as needed or assigned. Learn more about our EEO & Accommodations request here. Show more Show less

Exp in PV activities, Co-ordination with PV service provider. SOPs Handling Maintenance of PV database Co-ordination with Lambda provider. Required Candidate profile sunil@flamingopharma.com,hr1@flamingopharma.com Contact No.9769487298

Department- Commercial, GBS Are you passionate about taking your competitive intelligence journey to next level? Do you want to work for a globally renowned organization Novo Nordisk? We are seeking a Global Competitive Intelligence Associate Lead to join our vibrant and fast-moving Commercial-GBS team in Bangalore, India. If that sounds like you, read on and apply today for a life-changing career. The position As a Global Competitive Intelligence Associate Lead at Novo Nordisk, you will be responsible for: Consistently track and monitor activities of pharmaceutical competitors and man-aging news on competitors from key scientific and clinical congresses within the TA, relevant for research, development projects, and brand strategies. Ensure timely monitoring, analysis, and communication of all relevant competitor activities to the stakeholders and establish comprehensive and up-to-date snap-shots of competitive landscapes in all areas, including competitor pipelines, projected approval timelines, and existing products. Provide regular updates with strategic implications for the company, highlighting new trends, market events, assessing landscapes, and unmet needs. Also, delivering focused deep dives on specific topics. Drive process to establish an overview of near, medium, and long-term challenges and opportunities posed to Novo Nordisk and offering ongoing assistance to relevant project teams. Lead coverage of major scientific congresses pertinent to therapy area for competitor activities. Qualifications We are looking for candidates with the following qualifications: A Masters degree in Life Sciences, Medicine, or Pharmaceutical Sciences. Over 8 years of experience in the Competitive Intelligence sector, specifically within the pharmaceutical industry. Ability to carry out daily responsibilities autonomously and skilled in staying updated with industry trends and therapy area knowledge, while adapting quickly. A strong understanding of essential aspects related to drug development and marketing. This includes knowledge in therapy areas, drug landscapes, disease comprehension, market insights, clinical and regulatory aspects, and recognizing forthcoming opportunities. Proven competence in effectively communicating scientific, technological, and commercial information to different organizational levels paired with a strategic mindset and analytical capabilities. A highly self-driven, proactive and organized approach, with excellent collaboration and communication skills when interacting with stakeholders across the global NN organization (Denmark and Bangalore). About the department The Commercial- GBS unit is responsible for driving deliverables for multiple Corporate Vice President (CVP) areas within Commercial- GBS. This includes Insulin, GLP-1 and Obesity Marketing, Market Access, Insights, and Commercial Operations. Located in Bangalore, India, our team is dynamic and fast-paced, working together to make a difference in the lives of patients worldwide.

Department- CMR (Clinical, Medical, Regulatory & Pharmacovigilance) Location- Bangalore / Hyderabad Are you an experienced medical professional and passionate about Clinical Medical? Does being part of a growing, yet dynamic environment excite you? If yes, then you may be the one we are looking for as Clinical Medical Manager for Novo Nordisk India. Apply now! The position As a Clinical Medical Manager, you will be responsible for : Facilitate the execution of clinical trials related to New Therapy Areas (including CVD, CKD, NASH) by providing medical/scientific expertise and advice. Identify and map KOLs, investigators, and research centres within the relevant therapy areas. Collect early scientific insights and guidance by discussing relevant early development data with external medical and scientific experts. Contribute to delivering successful clinical trials (phase I-IV) in collaboration with clinical operations. Provide timely medical guidance and internal training to clinical staff. Engage in extensive scientific communication both internally and externally, requiring strong presentation skills. Performing ad hoc visits, Supporting attendance at investigator meetings, ensuring KOL inclusion in clinical trials and engaging key investigators to communicate trial results. Qualifications To be successful in this role, you should have the following qualifications: MD in any discipline with a strong clinical research/medical affairs background. 5 years of clinical or pharmaceutical industry experience with strong experience in human healthcare research either from university, CROs, or pharmaceutical industry. Expertise in therapeutic areas of relevance (CVD, CKD, NASH), preferably with authorship in peer-reviewed journals. Understanding of pharmaceutical drug development. Open to domestic and international travel in connection with site visits, congresses, and company events. Experience as a clinical trial investigator or sub-investigator. Understanding the specificities and nuances of the local healthcare infrastructure. About the department The CMR (Clinical, Medical, Regulatory & Pharmacovigilance) team based in Bangalore. Our team is dedicated to driving clinical trials and providing medical/scientific expertise in New Therapy Areas. We work closely with KOLs, independent professional associations, and patient advocacy associations to ensure the successful execution of clinical trials. The atmosphere is collaborative and dynamic, with a strong focus on scientific excellence and patient outcomes.

Department-Centralised Monitoring Unit (CMU) Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your career objectives? Then 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 in Pharmacology preferred; MBBS & MD in other clinical or paraclinical areas with relevant experience in clinical patient management or clinical research will also be considered). Preferably 3-5 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.

CLINIMINDS IS RECRUITING THIS POSITON FOR THE THE US BASED GLOBAL PHARMA CONSULTING AND PHARMACOVIGILANCE FIRM Role & responsibilities The Associate Director will lead the medical evaluation of Individual Case Safety Reports (ICSRs), oversee the clinical review of aggregate safety reports (e.g., PBRERs, DSURs, ACOs), and provide strategic and medical input in signal detection and benefit-risk assessments for the companys product portfolio, including biosimilars. The role ensures compliance with global regulatory requirements and drives excellence in pharmacovigilance science. ICSR Medical Review Aggregate Report Review Signal Management Cross-functional Collaboration Preferred candidate profile PEOPLE LEADER The above list reflects the general details necessary to describe the expectations of the position and shall not be construed as the only expectations that may be assigned for the position. An individual in this position must be able to successfully perform the expectations listed above. MINIMUM KNOWLEDGE, SKILLS, AND ABILITIES: The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required. Education (MBBS/ MD) or comparable education. Experience and/or Training: A minimum of 10 years of drug safety experience. Should have valuable experience in literature review for both Pre-authorization and Post marketing products. Should have valuable experience in reviewing aggregate reports and signal management activities. Technology/Equipment (Microsoft Proficient).

Company Name: IQVIA Experience: 5+ Years Location: Ahmedabad/Kolkata (Hybrid Model) Interview Mode: Virtual Interview Rounds: 2-3 Rounds Notice Period: Any Generic description: Your primary responsibility will be validating and quality checking safety database fields on assigned projects. You will also provide input for and review relevant safety tracking systems for accuracy/quality and perform safety review of clinical data (case report forms) and patient labs. You will have knowledge of drug safety databases, preferably ARGUS. You will have the ability to produce high quality work, with meticulous attention to detail. You will be fluent in verbal and written English, with excellent communication skills.

Basic Section No. Of Openings 1 External Title Cluster Manager - MF Employment Type Permanent Employment Category Field Closing Date 13 Jun 2025 Organisational Entity Equitas Small Finance Bank Business Unit Assets Division/Function (SBU) Inclusive Banking - MF Department Micro Finance Sub-Department Business Generic Role Cluster Manager External Title (Job Role) Cluster Manager - MF Division Inclusive Banking - MF Zone West State Maharashtra Region Pune Area Kolhapur Cluster Datta Nagar PT Location Maharashtra Branch Code 9064 Branch Name Datta Nagar Skills Skill Sales Highest Education Bachelor of Arts Working Language Marathi About The Role anage the Branch in terms of achieving defined member target for the branch , Branch operations and administration. 2.Build a high Quality Loan portfolio 3.Track and Ensure Repayments of the Loan disbursed 4. Maintain Manage Acquit ion of micro finance member and collection of the branch 5.Enable sales team to high performance and be a team player 6.To Build and Nurture team & enable them to achieve high performance as per the branch capacity & budget. 7. Manage Administrative smooth functioning of the branch 8. Conversion of Micro finance eligible member to enroll recurring deposit of the bank 9.Lead generation for existing micro finance members who require MICRO LAP or MICRO Housing 10. Ensure consistent delivery of Equitas products and services and prompt repayment in an efficient and cost effective mann

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 Standard Operating Procedures (SOPs) and internal guidelines under guidance and support of senior operation team members. JLPT N3 certification is mandatory 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. Read and acknowledge all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Work towards ensuring your individual training plan and training transcript are reconcilable. 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. Liaise with different functional team members, e.g. project management, clinical, data management health care professionals e.g. investigators, medical monitors, site coordinators and designees to address project related issues. May liaise with client in relation to details on day to day case processing activities. 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. Perform other duties as assigned. Lead/ Support department Initiatives 100% compliance towards all people practices and processes In addition to the above mentioned responsibilities, depending on the project requirement, the team member may perform medical review of non-serious adverse events (AEs) and non-serious adverse drug reactions (ADRs) which includes reviewal of AE coding, past medical history, concomitant medications, expectedness/ listedness, causality assessment and other medical information and ensure completeness and accuracy of data according to applicable regulations and guidelines, SOPs, project-specific guidelines, and medical evaluation guidelines and communicate with the team leads for any correction required in the case and maintain appropriate documentation for all communications. Qualifications Bachelors degree in life sciences or related field and up to 3 years of relevant experience, inclusive of up to 1 year of Pharmacovigilance experience. Req or equivalent combination of education, training and experience. Pref Good knowledge of medical terminology. Intermediate Working knowledge of applicable Safety Database and any other internal/Client applications. Intermediate Knowledge of applicable global, regional, local clinical research regulatory requirements. Intermediate Excellent attention to detail and accuracy. Intermediate maintain high quality standards. Intermediate Good working knowledge of Microsoft Office and web-based applications. Intermediate Strong organizational skills and time management skills. Intermediate 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, meet strict deadlines, manage competing priorities and changing demands. Intermediate Ability to delegate to less experienced team members. Intermediate Ability to be flexible and receptive to changing process demands. Intermediate Willingness and aptitude to learn new skills across Safety service lines. Intermediate Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients. Intermediate Ability to work as a Team Player, contribute and work towards achieving Team goals. Intermediate Ensure quality of deliverables according to the agreed terms. Intermediate Demonstration of IQVIA core values while doing daily tasks Advanced Extensive use of telephone and face-to-face communication requiring accurate perception of speech. Intermediate Regular sitting for extended periods of time. Intermediate May require occasional travel. Intermediate Flexibility to operate in shifts. Intermediate

About The Role : Job titleBond Analytics Analyst Corporate titleAVP LocationBangalore, India Role Description OverviewBusiness Division Deutsche Banks Corporate Bank (CB) a market leader in cash management, trade finance & lending, securities services and Trust & Agency Services. Focusing on the treasurers and finance departments of corporate and commercial clients and financial institutions across the globe, our universal expertise and global network allows us to offer truly integrated and effective solutions. OverviewBusinessTrust and Agency Service (TAS): With offices in New York, California, London, Frankfurt, Milan, Lisbon, Dublin, Hong Kong, Singapore and Tokyo, the Trust and Agency Services team at Deutsche Bank has long been recognized as a leader in the provision of administrative and fiduciary services to the global debt and equities markets. It supports structures from the simplest to the most complex, covering Asset Backed Securities, CLOs and Managed accounts, Corporate Debt, Escrows, Project Finance, Loan Agency, and Depositary Receipts. OverviewTeam: TAS Analytics group within Corporate Trust business of Deutsche Bank is supporting the Structured Finance products like ABS/MBS/CDOs and other Debt products like Syndicated Loan transactions where DB acts as Trustee and/or Agent. As Trustee and/or Agent, DB is responsible for performing various calculations including but not limited to Bond Payments and Tax Calculations for new and existing bond issuances. Group has exposure to Corporate Trusts business in understanding the Structured Finance and other Debt products and its Analytics requirements along with supporting the CSG activities. The successful candidate will be required to cover European working hours supporting the EMEA/Americas business. Corporate title will depend on the relative experience of candidate. What we'll offer you As part of our flexible scheme, here are just some of the benefits that youll enjoy Best in class leave policy Gender neutral parental leaves 100% reimbursement under childcare assistance benefit (gender neutral) Flexible working arrangements Sponsorship for Industry relevant certifications and education Employee Assistance Program for you and your family members Comprehensive Hospitalization Insurance for you and your dependents Accident and Term life Insurance Complementary Health screening for 35 yrs. and above Your key responsibilities Read and interpret governing legal and issuer documents namely Prospectuses/Offering Circulars, Bond Indentures and Pooling and Servicing Agreements, Hedging Agreements, etc. Process and review Bond Payments for MBS, ABS, CDO and similar kinds of structured product deals in an In-House platform (iMAKE) based on the Offering Circulars/Indenture/Pooling & Servicing Agreement and using the best practices followed in the Group. Offer the highest level of customer service by understanding overall deal structure and bond payments to provide internal and external clients with explanations to support cash flow model output. Establish the guidelines for receipt and appropriate format of underlying asset-level collateral that supports bond payments, as well as research and resolve any data accuracy issues. Involvement in ad hoc/special projects which support process improvement and the implementation of technology initiatives. Understand and analyze issues and offer practical solutions. Working independently with a minimal degree of supervision is required to exercise independent judgment. Your skills and experience Bachelor of Science/Engineering or qualified CA/CFA with a high GPA and a minimum of 2 years of professional experience. Previous experience in developing cash flow models, and exposure to securities industry. Must have proven skills in MS Excel and/or MS Access with good scripting skills in VBA. Experience in using SQL Demonstrated ability to handle multiple and often competing projects under tight deadlines and pressure. Must project a Customer/Client service focus. Responsible for supporting efforts to mitigate and control operational risk. Must be organized, focused, and possess strong communication and analytical skills. Demonstrated ability to work and think independently, while supporting team goals/objectives. How we'll support you Training and development to help you excel in your career Flexible working to assist you balance your personal priorities Coaching and support from experts in your team A culture of continuous learning to aid progression A range of flexible benefits that you can tailor to suit your needs About us and our teams Please visit our company website for further information: https://www.db.com/company/company.htm We strive for a culture in which we are empowered to excel together every day. This includes acting responsibly, thinking commercially, taking initiative and working collaboratively. Together we share and celebrate the successes of our people. Together we are Deutsche Bank Group. We welcome applications from all people and promote a positive, fair and inclusive work environment.

Perform triage & intake of ICSR received daily in ARGUS databases Should have hands On Experience On ARGUS Safety Database Should Have hands on Experience on MEDDRA Applicants Should Complete Certification in Pharmacoviiglance Required Candidate profile B.Pharm / M.Pharm/Pharm D/Life sciences degree With Hands On Experience On Argus Safety Database and Med DRA coding, Argus, Narrative Writing, Triage

Job Description We are currently seeking a QA Auditor - PV to join our growing team. The role will include the following: Implement and maintain the pharmacovigilance system, quality process and metrics Conduct audits of projects, systems, processes, and vendors, as assigned Support with preparation for hosting customer audit and PV inspections Desirable Skills and Experience 5+ years of experience in Global PV System Management in pharmaceutical companies or in PV Service Providers demonstrating a strong understanding of PV principles and practices 3+ years experience in conducting GCP and GVP audits Experience in CAPA Management A strong understanding of GVP guidelines 3+ years experience managing PV Quality Management Systems Bangalore, India Life Science degree or above. Would prefer MSc, M. Pharm, or B. Pharm/BDS Associate Regulatory and Safety Full Time

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations be future ready. We offer accelerated, global growth opportunities for talent thats bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast track career where you can grow along with Indegene’s high-speed growth. We are purpose-driven. We enable healthcare organizations be future ready and our customer obsession is our driving force . We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work. If this excites you, then apply below. Responsibilities: Perform triage & intake of ICSR received daily in ARGUS databases within the agreed timelines Monitor and download ICSRs from Eudravigilance (EV) for valid ICSRs Processing literature, spontaneous as well as clinical trial and solicited cases Schedule and perform search of literature reports for valid ICSR in PubMed and MLM Responsible for generation of reports and submission to health authority and business partners Ensure data entry of serious and non-serious ICSRs (Spontaneous, Solicited and literature) in ARGUS as per client SOP and WI with high level of data accuracy Responsible for coding events, indications and patient history based on MEDDRA Coding of suspect products as well as concomitant., Amending the narrative when required, Performing Labeling of events Responsible to obtain follow-up information for all serious and non-serious cases as per the guideline on Good Pharmacovigilance Practices (EU-GVP). Perform the submission of the processed cases to regulatory authority and report distribution to Partner. Communicate and interact effectively within and across all client key stakeholders and within internal team management as appropriate Attend all the internal trainings and client trainings and ensure compliance with applicable guidelines Track and perform daily and monthly reconciliation of ICSRs as per client requirements EDUCATION: M.Pharm/Pharm D/Life sciences degree EXPERIENCE: A minimum of 1 year pharmacovigilance case processing experience or its equivalent. EQUAL OPPORTUNITY Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate’s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.

Reviews the doctor s notes and the drug chart and acts as required Prepares nursing care plans and renders effective bedside nursing care Ensures medication safety and patient safety protocols are practiced. Manpower deployment prepares duty roster; assigns nursing and anesthesia technician as per requirements. Ensures efficient staffing, material, and equipment availability. Ensures nurses are competent and can handle tasks assigned to them. OT Scheduling: plans following day checks the booking register a day before surgery, notes and actions special requirements, co-ordinates with the surgeon & anesthetist; plans manpower, equipment and ensures OT is fully prepared for the specific surgery. Responsible for ensuring additional requirement of resource, blood procurement, equipment is made available Checks to ensure medications, consumables, instruments and equipments are available for the surgery. Ensures all equipment are fully functional; conducts random checks of surgical and laparoscopic instruments ensuring they are functional. Competently handles all equipment used in patient care; ensures team is competent in usage; ensures equipment is serviceable and readily available. Ensures documentation for all completed surgeries is updated and accurate. Maintains emergency stock of medications and consumables in OT. Co-ordinates with OT technician, biomedical team and housekeeping staff. Responsible for material management and cost control documentation, Indenting, receiving stock, storage and usage. Ensures no wastage and misuse. Responsible for narcotic management storage & documentation of usage. Aware of NABH & Nursing excellence standards and ensures implementation. Job Category: Nursing Job Type: Full Time Job Locations: Bangalore Experience: 7-10years Qualification: GNM / B. Sc (Nursing)

The Senior Associate, Global Submission Management – Americas, will help ensure the smooth compliant flow of information between all functional areas, internal and external to GRAAS, including local offices, external partners and regulatory authorities within the North American context. This role leads the creation of regulatory submissions through detailed planning and delivery of regulatory submission components and product dossiers, bringing technical expertise to drive operational excellence, innovation and ensured technical compliance of Amgen's global regulatory submissions. The ideal candidate will have a strong background in international submission management and Regulatory submissions. Roles & Responsibilities: Lead/support various Clinical Trial and Marketing Application type submissions and associated Global/Submission Content Plans. Participation in information system and software update projects as well as ongoing system validations Serve as point of contact between Amgen’s functional contributors and external partners, to ensure smooth delivery of regulatory submissions to identified agencies and subsequent archival in Veeva Vault RIM. Independently remain current on guidance (internal/external) and translate requirements into operational activities. Represent departmental expertise on regulatory projects and regional/global workstreams. Ensure procedures are in place and followed for the processing of incoming and outgoing regulatory documentation from a publishing perspective Contribute to the development of the strategy for communicating with global health authorities Initiate, lead and manage process development and improvement Participation in information system and software update projects as well as ongoing system validations Required Knowledge and Skills: Advanced technical and project management skills, demonstrated experience working in and leading teams Working knowledge of worldwide regulatory submissions in "electronic Common Technical Document" (eCTD) format, NeeS and paper, including, but not limited to original applications; amendments; supplements; periodic/annual reports; promotional materials; meeting packages; etc. Advanced knowledge of Veeva Vault RIM and the creation, maintenance and overall management of Global/Submission Content Plans, reports and dashboards Advanced knowledge of Global, International and Emerging Markets Marketing Application submission requirements, country specifications, and software used Advanced knowledge of eCTD, eCTD Specifications and eCTD software used by regulatory publishing groups (Lorenz docuBridge Explorer preferred) Preferred Knowledge and Skills: Advanced knowledge of Veeva Vault RIM, Expertise in the regulations and regulatory guidance applicable to global Clinical Trial and Marketing Applications Strong project management skills specifically related to regulatory projects, and working across company disciplines (e.g., Clinical, Safety, CMC, Nonclinical, Labeling, Regulatory Strategy) to ensure timely delivery and operational execution of regional/multi-country submission filing plans. Basic Education and Experience: Master’s degree and 3-4 years of directly related experience OR Bachelor’s degree and 4-6 years of directly related experience OR Associate’s degree and 6-8 years of directly related experience OR High school diploma / GED and 8+ years of directly related experience Preferred Education and Experience: Practical experience with submission requirements for US, Canada and South America

Manager, CSAR – Custom function Programming What you will do Let’s do this. Let’s change the world. We are looking for a dedicated individual to join us as a Study Designer and Edit Check Programmer, reporting directly to the Sr. Manager, Clinical Systems and Analytical Reporting. The successful candidate will play a crucial role in adhering to Amgen standards, procedures, and best practices to build and program studies in our clinical trial database. This position will require effective partnership with other CSAR Operations and cross-functional staff to ensure seamless, high-quality deliverables and activities related to the use of electronic data capture technology. We are seeking a strong leader who can confidently influence collaborators and contribute individually to study-specific and general CSAR/GDO projects or operational work. The ideal candidate will have proven experience in partnering effectively with cross-functional teams to deliver systems support and study deliverables. Additionally, they should have operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC). Responsibilities include, but are not limited to, the following: Support of clinical trial platform technologies Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Coordinating and providing programming support to Clinical Study Teams Ensure efficient and consistent use of EDC system and ensure the use is aligned with the established procedures or standards. Acting as a technical point of contact for systems deliverables on defined programs Identify, recommend or implement system enhancements, new tools or emerging technologies to decrease database development cycle times and foster a collaborative working environment. Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Ensure documentation supports CSAR operational or technical activities is in a complete manner and consistent with regulatory and the established processes. Assist in preparing for and responding to audit findings (internal or external). Knowledge Good Clinical Practice Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking Drug development and clinical trials processes Data management processes Clinical trial databases and applications Edit check development and Custom function programing Programming Languages Systems development lifecycle Project planning and management Collaborating with global cross-functional teams (team/matrix environment) Quality management and Risk Analysis Regulatory filings and inspections Process improvement methodologies Preferred Qualifications Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related field Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena General project management and planning experience Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, IRT vendors, etc.) Basic Qualifications Bachelors degree or equivalent in life science, computer science, business administration or related field Specialist knowledge / experience in life sciences or a medically related field General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company) What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Roles & Responsibilities: Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with regulatory requirements and the agreed strategy defined by the cross functional team Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting Collaborate with team members to resolve problems and escalate issues Record and maintain written redaction strategy for the study and product Manage timelines and coordinate work across team Required Skills: Experience understanding and interpreting data/information and its practical application Self-motivated with developed skills in multi-tasking, attention to detail, and follow-through Ability to follow controlled processes Excellent spoken and written English Project management skills, including ability to prioritize work in order to meet required deadlines Problem solving ability Basic Qualifications: Degree with 2-5 years of experience working with regulatory documents in a biotech/ pharmaceutical environment Familiarity with clinical research and clinical regulatory documents Knowledge of clinical trial disclosure regulations, guidelines, and best practices ? EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

Manager - International Regulatory Lead Role NameManager – International Regulatory Lead (IRL) Department NameInternational Regulatory Team, Global Regulatory Affairs Role GCF5A ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. ABOUT THE ROLE Role Description: The International Regulatory Lead (IRL) Manager will provide regulatory leadership & expertise for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to - optimize product development and regulatory approvals in International countries - develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management. Roles & Responsibilities: Advises Global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and objectives. Provides regulatory direction/expertise on the international regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, expedited regulatory designations, regulatory reliance mechanisms, compassionate use and pediatric plans). Under general supervision, plans regulatory submissions (e.g. clinical trial, marketing authorization applications and lifecycle management) for products within Amgen's portfolio. Under general supervision, contributes to the development of international regulatory strategy documents (regulatory product filing plan, strategies, risks associated with the potential Agency outcomes and contingency planning, estimate likelihood of success) and communicates to others, as appropriate. Provides and maintains clinical trial and/or marketing application documentation (excluding Chemistry, Manufacturing & Controls documentation). May author documents/redact such documents to support a regulatory filing. Directs development of and manages the international label submission strategy, leads the negotiation activities with cross-functional teams and is accountable for the label deviation requests and outcomes. Supports local regulatory teams in triaging queries from health authorities, and where appropriate, helps identify existing responses to same or similar questions, leveraging knowledge management. Participates as a member of the Global Regulatory Team (GRT), and various global clinical and labelling focused teams. Shares regulatory information and implications with the GRT and other global teams on an ongoing basis and provides advice on international considerations. Partners with peers to agree on product strategy including projected submission and approval time. Maintains regular communications with the local teams to ensure alignment on strategy and to share product development status. Builds effective relationships and communication paths across the global, regional and local elements of the global regulatory affairs function. Maintains an awareness of new and developing legislation, regulatory policy and technical regulatory guidance relating to Amgen products. Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement. Basic Qualifications and Experience: Doctorate degree OR Master's degree and 3 years of relevant regional regulatory experience OR Bachelor's degree and 5 years of relevant regional regulatory experience OR Associate degree and 10 years of relevant regional regulatory experience OR High school diploma/GED and 12 years of relevant regional regulatory experience. Functional Skills: Must-Have Skills: Knowledge and experience in the international regulatory environment of clinical trial applications, non-clinical and/or clinical variations to marketing authorizations and product labelling relevant for biotechnology and/or oncology products Comprehensive knowledge of regulatory principles and understanding of regulatory activities, and how they impact other projects and/or processes General awareness of the registration procedures/challenges in International countries for Clinical Trial Applications, Marketing Applications and lifecycle management activities. Good-to-Have Skills: Ability to resolve conflicts and develop a course of action leading to a beneficial outcome Cultural awareness and sensitivity to achieve results across country, regional and international borders. Soft Skills: Strong communication skills, both oral and written Ability to understand and communicate scientific/clinical information Ability to work effectively with global, local and virtual teams High degree of initiative and self-motivation Planning and organizing abilities Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Good negotiation and influencing skills. EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. Key Activities Contributes to product teams and acts as product lead or principal for one or more products. Provides strategic regulatory input and regulatory risk assessments for product teams; executes regulatory strategy with respect to preparation of submissions; complies with critical RA CMC processes; identifies need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance; reports needs for process changes to CMC systems and contributes to process improvements; incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams; reports issues to RA CMC product team management . Key Responsibilities Include: Generate and execute of global and country-specific regulatory strategies Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments Develop global dossiers for CMC content for initial submissions, variations and amendments Support change management activities Develop response strategy and respond to health authority questions Liaise with other functions in development, operations and commercial to ensure alignment of global regulatory strategies, timing, execution and supply plans Liaise with local regulatory teams to align on filing strategy Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current. Maintain submission information according to the Regulatory Information Management (RIM) system Follow established department regulatory processes to ensure cross-product alignment Knowledge and Skills CMC- specific regulatory knowledge & experience Education & Experience (Basic) Doctorate degree OR 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 and10 years of directly related experience OR High school diploma / GED and12 years of directly related experience Education & Experience (Preferred) Experience in manufacture, testing (QC/QA or clinical), or distribution Regulatory CMC experience

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Service Delivery Ops Specialist Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 7 to 11 years What would you do? "You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. " What are we looking for? "Aggregate Safety Report ScientistAggregate Safety Report Scientist" Roles and Responsibilities: " In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts" Qualification Bachelor of Pharmacy,Master of Pharmacy

Madurai HCL Tech is hiring candidates for PMS Analyst role. We are looking for candidates from B.E/B.Tech. Mechanical graduates who is interested in working for Medical domain. The 1st level of interview will be a Face to Face in Madurai office premises. Looking for candidates who passed out their Mechanical graduation with Engineering in 2022/2023/2024. Interested candidates please share us your updated resume along with the below details in mail to keeshouley.m@hcltech.com. Candidate Name: Candidate DOB: Graduation: Passed out year: Current location: Native location: Total Years of Experience: Relevant Years of Experience: Current CTC: Expected CTC: Notice Period: Interested to come for walk-in interview to Madurai premises: Regards, Keeshouley M