1738 Pharmacovigilance Jobs - Page 32

Role & responsibilities Spotfire developer who has worked in Pharmacovigilance reporting BI Data Visualization - TIBCO Spotfire~LS - Pharmacovigilance (Argus), 6-8 Years , Preferred candidate profile Only immediate joiners with Spotfire and TIBCO experience

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Specialist Qualifications: MBBS Years of Experience: 7 to 11 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.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 Required MBBS graduateRequired MBBS graduate 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 MBBS

About AstraZeneca AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. 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 AstraZeneca 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, AstraZeneca 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 AstraZeneca 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 AstraZeneca’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 AstraZeneca 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 AstraZeneca 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. Essential Education, Qualifications, Skills and Experience 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. Why AstraZeneca? At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare. Date Posted 14-May-2025 Closing Date 29-Jun-2025 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Job Summary The SME-Pharmacovigilance role is crucial for ensuring the safety and efficacy of pharmaceutical products. The candidate will leverage their expertise in PV Case Processing and customer service to enhance pharmacovigilance operations. This position requires a proactive approach to monitoring drug safety and contributing to research and development efforts. Responsibilities Triage & intake of ICSRs in ARGUS databases within agreed timelines Download and monitor valid ICSRs from Eudra Vigilance (EV)- or any other sources Process literature, spontaneous, clinical trial, and solicited cases Search for valid ICSRs in Literature search tools Generate reports and submit to health authorities and business partners Enter serious and non-serious ICSRs in ARGUS per client SOP and WI with high accuracy Code events, indications, patient history using MedDRA Code suspect products, amend narratives, and label events Obtain follow-up information for all cases per applicable guidelines Submit processed cases to regulatory authorities and distribute reports to Partners Communicate effectively with client stakeholders and internal teams Attend all internal and client trainings to ensure guideline compliance Ensure adherence to regulatory requirements and industry standards in all aspects of pharmacovigilance and safety operations. Assist in the development and maintenance of standard operating procedures to ensure consistency and quality in process execution. Support training and development initiatives to enhance team capabilities and knowledge in pharmacovigilance and safety operations. Utilize technical skills to troubleshoot and resolve process-related issues, minimizing disruptions and ensuring smooth operations. Engage in rotational shifts to provide consistent support and coverage across different time zones. Requirements Bachelor’s / Master’s degree in pharmacy. Minimum 3 years relevant work experience in case processing activities. Experience in Cardiovascular (CVS), Neuroscience (CNS), Oncology, Immunology therapeutic areas and Gene Therapy will be an added advantage. Experience with global pharma sponsor will be preferred. In-depth knowledge and understanding of applicable global, regional, and local regulatory requirements, including Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and International Conference of Harmonization (ICH) guidelines, SOPs. Excellent organizational and time management skills. Proficiency in Microsoft Office and web-based applications (e.g., Word, Excel, PowerPoint). Good knowledge of medical terminology.

Employment Type: Contract Top 3 skills which is mandatory Aris, BPM, Functional and Technical Setup and ongoing maintenance and oversight of the ARIS architecture & libraries Design and develop the reporting capabilities on ARIS to meet the requirements of the Group Configuration of ARIS system for the Process Mapping team ensuring it remains fit for purpose for the Group`s requirements. Develop detailed understanding of ARIS standard setup and functionality Responsibility for the day-to-day administration of ARIS including user set up, licence allocation, recertification, etc. Ensure ARIS system procedures remain accurate and up-to-date with Group`s policies and standards. Repository Clean up Management of new library content scripts vs manual maintenance Integrations Vs schedule reports to ABACUS, Radar and HR Process Governance for change and release management ARIS reporting

Job Summary The SME-Pharmacovigilance role is crucial for ensuring the safety and efficacy of pharmaceutical products. The candidate will leverage their expertise in PV Case Processing and customer service to enhance pharmacovigilance operations. This position requires a proactive approach to monitoring drug safety and contributing to research and development efforts. Responsibilities Triage & intake of ICSRs in ARGUS databases within agreed timelines Download and monitor valid ICSRs from Eudra Vigilance (EV)- or any other sources Process literature, spontaneous, clinical trial, and solicited cases Search for valid ICSRs in Literature search tools Generate reports and submit to health authorities and business partners Enter serious and non-serious ICSRs in ARGUS per client SOP and WI with high accuracy Code events, indications, patient history using MedDRA Code suspect products, amend narratives, and label events Obtain follow-up information for all cases per applicable guidelines Submit processed cases to regulatory authorities and distribute reports to Partners Communicate effectively with client stakeholders and internal teams Attend all internal and client trainings to ensure guideline compliance Ensure adherence to regulatory requirements and industry standards in all aspects of pharmacovigilance and safety operations. Assist in the development and maintenance of standard operating procedures to ensure consistency and quality in process execution. Support training and development initiatives to enhance team capabilities and knowledge in pharmacovigilance and safety operations. Utilize technical skills to troubleshoot and resolve process-related issues, minimizing disruptions and ensuring smooth operations. Engage in rotational shifts to provide consistent support and coverage across different time zones. Requirements Bachelor’s / Master’s degree in pharmacy. Minimum 3 years relevant work experience in case processing activities. Experience in Cardiovascular (CVS), Neuroscience (CNS), Oncology, Immunology therapeutic areas and Gene Therapy will be an added advantage. Experience with global pharma sponsor will be preferred. In-depth knowledge and understanding of applicable global, regional, and local regulatory requirements, including Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and International Conference of Harmonization (ICH) guidelines, SOPs. Excellent organizational and time management skills. Proficiency in Microsoft Office and web-based applications (e.g., Word, Excel, PowerPoint). Good knowledge of medical terminology.

JOB DESCRIPTION Job Title: Manager Sub-function: Pharmacovigilance- Quality Assurance (PV-QA) Function Corporate Quality Assurance Location - Vikhroli Job Details Job Purpose Pharmacovigilance (PV) Audits and risk assessment: Planning and conducting audits of PV processes, business partners, Cipla Offices, service providers and other departments related to PV function. Preparation and implementation of strategic and tactical level audit plan. To perform PV risk assessment. Facilitating external audits and regulatory inspections: Experience on handling of PV regulatory inspection eg. USFDA, MHRA, EMA, TGA etc. Quality Management System (QMS): Handling on deviation, CAPA, change management, documentation control on electronic software. Preparation, review and approval of QMS and PV SOPs. Record management process. End to end PV knowledge: Different source of safety information, PV mailbox case processing and literature screening, regulatory submission, knowledge of dictionaries (MedDRA, WHO DD, CPD), PV vendor management, Lavel update, PV/QMS training, Safety data exchange agreement, PSMF, Aggregate reports (RMP, PSUR/PBRER, PADER) and signal management. Key Accountabilities Accountability Cluster Major Activities / Tasks Pharmacovigilance Audits and Inspection Planning and conducting audits of PV processes, business partners, Cipla Offices, service providers and other departments related to PV function. Perform Vendor Qualification and its related activities. Conduct risk assessment of all PV processes, departments of Cipla other than DSD involved in PV System, Cipla Country offices, Cipla subsidiaries, business partner and service providers. Preparation and implementation of Audit schedule Facilitating external audits and regulatory inspections Deviation Handling and CAPA management Logging, approving, tracking and closing the deviations and CAPA raised in DSD. Initiation, Follow up and monitoring of open CAPAs. Closing and effectiveness review of CAPAs. Document Control Issuance, distribution, withdrawal, destruction of all the forms generated through approved written procedures for DSD. Preparation and review of written procedures related to Drug Safety Division (DSD) Quality Management System (QMS). Document retention and archival of all the DSD related documents. Training Training to DSD on QMS and related topics Identify need of training on QMS and related topics Change Request Coordinate change requests raised by DSD Review of PSMF, PvMF, or equivalent documents through change control system End to end Pharmacovigilance related activities Collection of safety information from Different source, PV mailbox case processing and literature screening, regulatory submission, knowledge of dictionaries (MedDRA, WHO DD, CPD), PV vendor management, Lavel update, PV/QMS training, Safety data exchange agreement, PSMF, Aggregate reports (RMP, PSUR/PBRER, PADER) and signal management. QMS software Trackwise, Vivo or any QMS software Major Challenges Communication with Cross function team to implement CAPA plan. Collection of data required to perform risk assessment Timely close of QMS activity Key Interactions InternalExternal Team Member, for discussion on concern to their activity / task and each and every assigned task on daily basis. DSD Team: Interaction with DSD team for closure of QMS document. CFT: Medical service depart, Corporate communication department, Corporate quality assurance, Clinical research department, CSV, IT, REMS. CFT: Cipla country offices and Subsidiaries External: Pharmacovigilance vendor, business partner for discussion of Audit requirement and implementation of CAPA plan. Dimensions Meet 100% compliance to Tactical level audit plan and risk assessment Ensure change request, Deviation and CAPA shall get raised within timeline. Meet 100% compliance timely closure of QMS documents i.e. Deviation, CAPA and change management. Ensure timely training imparted in QMS topics for key PV personnel. Ensure completeness, accuracy of QMS documents. Timely resolution of internal and external queries. Key Decisions: DecisionsRecommendations Inputs on resolution of queries from CFTs. Approve Process Deviations Make process improvements as needed. Mentoring CAPA owners on proper techniques Inspection Readiness Assistance to cross functional team To Share industry best practices To increase the awareness on regulatory intelligence. Process simplifications. Comments: The said Job description will involve adequate knowledge PV audit, QMS and End to end knowledge of PV system. Skills & Knowledge Educational qualifications: Qualified pharmacist (B. Pharma / M. Pharma). Relevant experience: He / She must have 10-14 years of Pharmacovigilance experience including audits and QMS. He / She must be technically sound on QMS function and exposure of regulatory audits like USFDA, MHRA, TGA, EMA, SHAPRA etc.

Primary Responsibilities: Maintain knowledge of coding and billing requirements and regulatory changes KPIs include but not limited to Productivity, quality, TAT, Attendance and Attrition Quick turnaround using logical understanding of data Manages overall personnel, performance, and discipline of the assigned project(s) Provide expertise and leadership in assigned functional area Manage relationship with internal stakeholders and functions Manage all client interaction and client communication. Should front end the relationship with the client Review and analysis of periodic reports and metrics Evaluation of operational practices and procedures Provide support to quality initiatives targeted towards process improvements Actively involved in the internal audit support, ensuring all compliance parameters are met Establish and maintain a working environment conducive to positive morale, individual style, quality, creativity, and teamwork Provide direction to staff; ensure resolution of problems; sets priorities Actively provides inputs and assistance to the senior management in the planning, implementation, and evaluation / modifications to existing operations, systems, and procedures, specifically relating to his/her assigned project(s) Managing attrition and building retention strategies Preparation of annual business plans including operating budgets Negotiating solutions, resolving conflicts and anticipating/handling critical situations Providing regular performance feedback and giving frequent formal and informal coaching sessions Comply with the terms and conditions of the employment contract, company policies and procedures, and any and all directives (such as, but not limited to, transfer and/or re-assignment to different work locations, change in teams and/or work shifts, policies in regards to flexibility of work benefits and/or work environment, alternative work arrangements, and other decisions that may arise due to the changing business environment). The Company may adopt, vary or rescind these policies and directives in its absolute discretion and without any limitation (implied or otherwise) on its ability to do so Required Qualifications: Graduate or Postgraduate inLife Sciences, Allied Medicine (BHMS, BAMS, BPT, Dental Grads, Pharmacist, Nursing) or others Certified coder AAPC / AHIMA CCS/CPC/CPC-H/CCS-P 10+ years of coding experience with about 3-4 yr experience as a Team Lead Knowledge of organizational structure, workflow, and operating procedures Thorough knowledge of medical terminology, human anatomy/ physiology, pathophysiology Proficient in healthcare reimbursement methodologies Proven ability to manage and enable teams to reach their goals Proven good analytical and communication skills Proven solid interpersonal and communication skills Proven solid acumen towards employee engagements & driving customer satisfaction Proven ability to work closely with SME, Auditor and Trainer and identify training needs for outliers Proven ability to effectively provide 1 on 1 coaching Proven ability to monitor absences and overall day to day operations Proven ability to identify areas of weakness and provide educational teaching to improve those areas of weakness At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone-of every race, gender, sexuality, age, location and income-deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes an enterprise priority reflected in our mission. #njp #NTRQ

Employment Type: Contract Setup and ongoing maintenance and oversight of the ARIS architecture & libraries Design and develop the reporting capabilities on ARIS to meet the requirements of the Group Configuration of ARIS system for the Process Mapping team ensuring it remains fit for purpose for the Group`s requirements. Develop detailed understanding of ARIS standard setup and functionality Responsibility for the day-to-day administration of ARIS including user set up, licence allocation, recertification, etc. Ensure ARIS system procedures remain accurate and up-to-date with Group`s policies and standards. Repository Clean up Management of new library content scripts vs manual maintenance Integrations Vs schedule reports to ABACUS, Radar and HR Process Governance for change and release management ARIS reporting

Location: Amberpet, Hyderabad Excellent communication skills Problem-solving mindset Identify diseases based on prescriptions Follow up with Patient Fluent in English, Hindi and (Tamil or Telugu or Malayalam ) Call or WhatsApp resume to: 7995542107 Required Candidate profile Pharmacy, Pharmacist, pharma, Clinical Pharmacy, Pharmacology, Pharmaceutics, Dispensing, Medicine, Medical, Clinical, Mpharm, Pharm D, Drug, Pharmacovigilance, Clinical Research, B Pharmacy Fresher,

Skills: Excellent writing and editing skills with the ability to create clear, concise, and engaging contentStrong knowledge of medical terminology, scientific concepts. #Exp5+ Years #LocationHydrabad (Hybrid) #clientNTTDATA. #Job description Good Experience in Medical Writer.

Job title: Senior Study Data Manager Location: IN / Hyderabad About the job Within the Clinical Trial Team (CTT), the Senior Study data manager is responsible for leading the end-to-end Clinical Data Management (CDM) activities and study deliverables supporting study set-up, conduct and close-out, complying with GCP and applicable regulatory guidance. Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives. Ready? As Senior Study Data Manager within our Clinical Data Management, you’ll be accountable for the quality of CDM deliverables and for ensuring accurate and reliable study data, therefore guaranteeing the reliability of the study results. The employee ensures activities are completed according to agreed standards and timelines. The employee provides comprehensive CDM expertise and supports team members by coordinating cross functional data related activities globally to ensure the flawless conduct of a clinical trial. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Major Responsibilities : Accountability for the quality of CDM deliverables (such as CRFs, CRF Completion Instructions, Centralized Monitoring Plan, Data Management Plan, Data Validation Specifications, Data Review Listings/Reports/Visualizations) and for the delivery of accurate and reliable clinical study data. Liaising directly with internal customers (Global Study Manager, Study Medical Manager, Statistician, Central Monitors, Pharmacovigilance, Quality, etc.) to coordinate all CDM activities for studies, discussing timelines, and providing CDM updates. Proactively anticipating and remediating CDM issues arising during study conduct and monitoring them until resolution. Defining and implementing data cleaning & validation strategy integrating risk-based approaches. Contributing to the protocol review, Study Risk Management Plan, SAE reconciliation, deviation review, data review, medical review, and other review activities during the conduct of a study. Leading study activities with internal and external (e.g., Providers) CDM delivery teams (Database Developers, Data Management Programmers, Central Monitors, etc.) and mentoring new Study Data Managers. Coordinating all external data activities: specifications, loading and reconciliation, including data collected through Central Labs, eCOA, IRT, connected devices, telemedicine, and mobile healthcare. About you Experience: experience on clinical data management and must have been in a project management role. Soft skills: Strong project management skills and experience. Anticipate delivery risks. Learn and adapt quickly when facing new problems. Good interpersonal, communication, and presentation skills. Technical skills: Strong experience with CDM and related regulations (incl. ICH E6 and E8). Solid risk-based mindset focusing on Quality by Design (QbD) and on what really matters. Understanding of advanced drug development concepts such as Decentralized Clinical Trials (DCT), Master & Adaptive Protocols, eSource and AI Based automations is a plus Education: Bachelor’s degree or above, preferably in a life science or drug development related field. Languages: Strong English skills (verbal and written), ability to exchange fluently in a global environment. Why choose us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Join an international innovative biopharma company. Participate in the evolution of Clinical Data Management and deployment of innovations.

Company Information At Advarra, we are passionate about making a difference in the world of clinical research and advancing human health. With a rich history rooted in ethical review services combined with innovative technology solutions and deep industry expertise, we are at the forefront of industry change. A market leader and pioneer, Advarra breaks the silos that impede clinical research, aligning patients, sites, sponsors, and CROs in a connected ecosystem to accelerate trials. Company Culture Our employees are the heart of Advarra. They are the key to our success and the driving force behind our mission and vision. Our values (Patient-Centric, Ethical, Quality Focused, Collaborative) guide our actions and decisions. Knowing the impact of our work on trial participants and patients, we act with urgency and purpose to advance clinical research so that people can live happier, healthier lives. At Advarra, we seek to foster an inclusive and collaborative environment where everyone is treated with respect and diverse perspectives are embraced. Treating one another, our clients, and clinical trial participants with empathy and care are key tenets of our culture at Advarra; we are committed to creating a workplace where each employee is not only valued but empowered to thrive and make a meaningful impact. Job Duties & Responsibilities Understand and interpret clinical trial study protocols to design and develop calendars. Understand and interpret clinical trial agreements and sponsor budgets to develop site budgets for the protocol. Design and develop case report forms for clinical trial study protocols Develop a familiarity with Advarra’s Clinical Trial Management Software (CTMS) and Electronic Data Capture (EDC) software to utilize related functionalities in the design and development of calendars, budgets, financials and case report forms. Work closely with reporting manager to complete daily/ weekly calendars, budgets, financials and/or case report forms design to meet with pre-determined quality criteria. Understand and utilize internal case management software and other reporting software to ensure that daily/weekly work assignments are appropriately tracked and completed. Actively participate in team meetings and contribute meaningfully to discussions related to specific customer cases and/or protocols. Location This role is open to candidates working remotely or hybrid in Bengaluru, India. Basic Qualifications 2+ Years’ of relevant experience Knowledge of clinical research methodology, industry regulations and Good Clinical Practice guidelines related to human research. Expected to work independently, as well as in a team environment. Good organizational and administrative abilities Familiarity with MS Office and various business software Preferred Qualifications Clinical trial coordinator at site Clinical data management Pharmacovigilance Records management Physical And Mental Requirements Sit or stand for extended periods of time at stationary workstation Regularly carry, raise, and lower objects of up to 10 Lbs. Learn and comprehend basic instructions Focus and attention to tasks and responsibilities Verbal communication; listening and understanding, responding, and speaking Advarra is an equal opportunity employer that is committed to diversity, equity and inclusion and providing a workplace that is free from discrimination and harassment of any kind based on race, color, religion, creed, sex (including pregnancy, childbirth, and related medical conditions, sexual orientation, and gender identity), national origin, age, disability or genetic information or any other status or characteristic protected by central, state, or local law. Advarra provides equal employment opportunity to all individuals regardless of these protected characteristics. Further, Advarra takes affirmative action to ensure that applicants and employees are treated without regard to any of these protected characteristics in all terms and conditions of employment, including, but not limited to, hiring, training, promotion, discipline, compensation, benefits, and separation from employment

Company Description We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device. We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved. Come and join us in this exciting journey to make a positive impact in patient’s lives. Job Description Engaging in everyday tasks, working on tickets, and maintaining oversight of personal and group tickets to ensure timely resolution. Closing and meticulously documenting resolutions or workarounds in the internal knowledgebase to facilitate knowledge sharing and improve future problem-solving efficiency. Conducting incident response, including first-line investigation, problem analysis, workaround development, and resolution or progression of IT incidents. Categorising, prioritising, and escalating IT incidents to appropriate resolver groups within Service Level Agreement (SLA) parameters. Performing maintenance of laptops and servers, including user and computer administration tasks to ensure optimal system performance. Managing equipment provisioning, including overseeing the onboarding and offboarding processes to maintain seamless workflow transitions. Developing and implementing proactive measures to prevent recurring issues and enhance overall system stability. Collaborating with cross-functional teams to design and implement IT solutions that align with business objectives and user needs. Mentoring junior team members and providing technical guidance to foster skill development within the IT support team. Creating and maintaining technical documentation, including standard operating procedures and user guides, to ensure consistent support delivery. Monitoring system performance and capacity, proactively identifying areas for improvement and optimisation. Staying abreast of emerging technologies and industry best practices and recommending innovative solutions to enhance the company's IT infrastructure and support capabilities. Training of Ergomed Group personnel on IT procedures as appropriate Qualifications 8 plus years relevant work experience in an IT support position Windows 11 and Windows Server 2019 (and newer versions) Microsoft Exchange 2016 (and newer versions) Microsoft SharePoint Online Administration of Office 365 PowerShell scripting Basic familiarity with IT security concepts, including encryption, IDS, IPS, and disaster recovery Networking skills, encompassing routing, switching, and firewall management Additional Information Why PrimeVigilance? We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow. To succeed we must work together with a human first approach. Why? Because our people are our greatest strength leading to our continued success on improving the lives of those around us. We offer: Training and career development opportunities internally Strong emphasis on personal and professional growth Friendly, supportive working environment Opportunity to work with colleagues based all over the world, with English as the company language Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join! Quality Integrity & Trust Drive & Passion Agility & Responsiveness Belonging Collaborative Partnerships Come and join us in this exciting journey to make a positive impact in patient’s lives. We look forward to welcoming your application!

Job Description About your role We have vacancy for Product information expert role in Regulatory Affairs team. We are looking for Executive/Senior executive. The candidate has the possibility to utilize his/her own strengths with the support of the professionals. Your Key Responsibilities Management and coordination of good quality PI documents such as company core data sheets (CCDS), Summary of Product Characteristics (SmPCs), package leaflets (PLs) and labelling in close co-operation with Regulatory Affairs and Pharmacovigilance, including Writing PI documents with support from Medical Affairs, Commercial Operations and Global Operations Document management and change control of PI documents Performing quality control of PI documents for accuracy and consistency Global coordination and guidance of internal PI related processes Assuring high quality processes, internal guidelines, standard operating procedures & internal templates What We Offer An excellent opportunity to work as a PI-specialist in different therapeutic areas Great opportunity to become part of the wholly owned subsidiary of globally operating Orion Group An opportunity to collaborate directly with your colleagues mainly in Finland & India, but also globally Possibility to utilize your own strengths with the support of the professionals Flexible, high-spirit working environment where your skills are appreciated Hybrid Work Policy (In a week - 3 days work from office and flexibility to work remotely for two times). Good work-life balance Clear, transparent processes and responsible supervisors are our benefits to the personnel At Orion, your work creates true impact and well-being for our customers, patients and society at large. Our culture of friendliness, respect, mutual appreciation and diversity creates a safe working environment where you can strive for excellence. We offer a wealth of career paths and development opportunities that support the development of innovative solutions and improving the quality of life. Please visit our website to find further information about our values and Orion as an employer https://www.orion.fi/en/careers/orion-as-an-employer/ . Our expectations 4 - 7 years of experience as Product Information Specialist in Pharmaceutical industry Advanced writing skills (e.g. SmPC, PL, other regulatory documents) Ability to understand complex medical terminologies and convert them into simple language Advanced computer and word processing (MS Word, Adobe Acrobat) skills Good communication and interpersonal skills Ability to prioritise, manage multiple projects & meet deadlines while delivering high quality documents Ability to work within teams (often remotely) as well as independently Positive attitude and willingness to learn and adapt, but also to teach and support co-workers and colleagues around the world Ability to keep sight of the bigger picture, while at the same time paying attention to details. Ability to work in a highly regulated industry Qualification Bachelor’s/Master’s degree in life sciences, B.Pharm/M.Pharm or health-related field from a reputed college How To Apply And Additional Information Email your CV on recruitmentindia@orion.fi & please share below details, Required documents, CV/Resume Current CTC, Expected CTC & Notice Period. Application deadline - 15.06.2025 Employer Description Orion is a globally operating Finnish pharmaceutical company – a builder of well-being for over a hundred years. Orion provides meaningful work for more than 3 600 Orionees in Finland and abroad. Orion is known as a responsible and reliable employer where we value each other, strive for the best and build for tomorrow. We develop, manufacture and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Orion has an extensive portfolio of proprietary and generic medicines and consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion are used to treat cancer, neurological diseases and respiratory diseases, among others. About Orion ABOUT US Orion is a globally operating Finnish pharmaceutical company – a builder of well-being for over a hundred years. Orion provides meaningful work for more than 3 600 Orionees in Finland and abroad. Orion is known as a responsible and reliable employer where we value each other, strive for the best and build for tomorrow. We develop, manufacture and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Orion has an extensive portfolio of proprietary and generic medicines and consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion are used to treat cancer, neurological diseases and respiratory diseases, among others.

:. Soul AI is a pioneering company founded by IIT Bombay and IIM Ahmedabad alumni, with a strong founding team from IITs, NITs, and BITS. We specialize in delivering high-quality human-curated data, AI-first scaled operations services, and more. . We are seeking a Medical Scriber with a background in healthcare and medical documentation. You will be responsible for assisting in the documentation of medical records and procedures. Key Responsibilities:. Accurately transcribe patient records and medical data. Assist in creating comprehensive medical reports and documentation. Ensure that records comply with relevant standards and regulations. Required Qualifications:. 1+ years of experience as a medical scribe or in medical transcription. Strong knowledge of medical terminology. Familiarity with electronic health record (EHR) systems. Why Join Us. Competitive pay (‚1200/hour). Flexible hours. Remote opportunity. NOTEPay will vary by project and typically is up to Rs. 1200 per hour (if you work an average of 3 hours every day that could be as high as Rs. . Shape the future of AI with Soul AI!.

:. Soul AI is a pioneering company founded by IIT Bombay and IIM Ahmedabad alumni, with a strong founding team from IITs, NITs, and BITS. We specialize in delivering high-quality human-curated data, AI-first scaled operations services, and more. . We are looking for an experienced Medical Consultant to provide expert medical insights and consult on healthcare-related projects to drive innovation in AI-powered health solutions. Key Responsibilities:. Provide expert advice and guidance on medical and healthcare-related projects. Review and analyze health data for AI-based applications. Collaborate with data scientists and engineers to design medical solutions. Required Qualifications:. 3+ years of experience as a medical consultant or practitioner. Strong understanding of medical research, healthcare systems, and clinical practices. Experience in telemedicine or healthcare technology is a plus. Why Join Us. Competitive pay (‚1200/hour). Flexible hours. Remote opportunity. NOTEPay will vary by project and typically is up to Rs. 1200 per hour (if you work an average of 3 hours every day that could be as high as Rs. . Shape the future of AI with Soul AI!.

:. Soul AI is a pioneering company founded by IIT Bombay and IIM Ahmedabad alumni, with a strong founding team from IITs, NITs, and BITS. We specialize in delivering high-quality human-curated data, AI-first scaled operations services, and more. . We are seeking a Medical Scriber with a background in healthcare and medical documentation. You will be responsible for assisting in the documentation of medical records and procedures. Key Responsibilities:. Accurately transcribe patient records and medical data. Assist in creating comprehensive medical reports and documentation. Ensure that records comply with relevant standards and regulations. Required Qualifications:. 1+ years of experience as a medical scribe or in medical transcription. Strong knowledge of medical terminology. Familiarity with electronic health record (EHR) systems. Why Join Us. Competitive pay (‚1200/hour). Flexible hours. Remote opportunity. NOTEPay will vary by project and typically is up to Rs. 1200 per hour (if you work an average of 3 hours every day that could be as high as Rs. . Shape the future of AI with Soul AI!.

:. Soul AI is a pioneering company founded by IIT Bombay and IIM Ahmedabad alumni, with a strong founding team from IITs, NITs, and BITS. We specialize in delivering high-quality human-curated data, AI-first scaled operations services, and more. . We are looking for an experienced Medical Consultant to provide expert medical insights and consult on healthcare-related projects to drive innovation in AI-powered health solutions. Key Responsibilities:. Provide expert advice and guidance on medical and healthcare-related projects. Review and analyze health data for AI-based applications. Collaborate with data scientists and engineers to design medical solutions. Required Qualifications:. 3+ years of experience as a medical consultant or practitioner. Strong understanding of medical research, healthcare systems, and clinical practices. Experience in telemedicine or healthcare technology is a plus. Why Join Us. Competitive pay (‚1200/hour). Flexible hours. Remote opportunity. NOTEPay will vary by project and typically is up to Rs. 1200 per hour (if you work an average of 3 hours every day that could be as high as Rs. . Shape the future of AI with Soul AI!.

:. Soul AI is a pioneering company founded by IIT Bombay and IIM Ahmedabad alumni, with a strong founding team from IITs, NITs, and BITS. We specialize in delivering high-quality human-curated data, AI-first scaled operations services, and more. . We are seeking a Medical Scriber with a background in healthcare and medical documentation. You will be responsible for assisting in the documentation of medical records and procedures. Key Responsibilities:. Accurately transcribe patient records and medical data. Assist in creating comprehensive medical reports and documentation. Ensure that records comply with relevant standards and regulations. Required Qualifications:. 1+ years of experience as a medical scribe or in medical transcription. Strong knowledge of medical terminology. Familiarity with electronic health record (EHR) systems. Why Join Us. Competitive pay (‚1200/hour). Flexible hours. Remote opportunity. NOTEPay will vary by project and typically is up to Rs. 1200 per hour (if you work an average of 3 hours every day that could be as high as Rs. . Shape the future of AI with Soul AI!.

:. Soul AI is a pioneering company founded by IIT Bombay and IIM Ahmedabad alumni, with a strong founding team from IITs, NITs, and BITS. We specialize in delivering high-quality human-curated data, AI-first scaled operations services, and more. . We are looking for an experienced Medical Consultant to provide expert medical insights and consult on healthcare-related projects to drive innovation in AI-powered health solutions. Key Responsibilities:. Provide expert advice and guidance on medical and healthcare-related projects. Review and analyze health data for AI-based applications. Collaborate with data scientists and engineers to design medical solutions. Required Qualifications:. 3+ years of experience as a medical consultant or practitioner. Strong understanding of medical research, healthcare systems, and clinical practices. Experience in telemedicine or healthcare technology is a plus. Why Join Us. Competitive pay (‚1200/hour). Flexible hours. Remote opportunity. NOTEPay will vary by project and typically is up to Rs. 1200 per hour (if you work an average of 3 hours every day that could be as high as Rs. . Shape the future of AI with Soul AI!.

:. Soul AI is a pioneering company founded by IIT Bombay and IIM Ahmedabad alumni, with a strong founding team from IITs, NITs, and BITS. We specialize in delivering high-quality human-curated data, AI-first scaled operations services, and more. . We are seeking a Medical Scriber with a background in healthcare and medical documentation. You will be responsible for assisting in the documentation of medical records and procedures. Key Responsibilities:. Accurately transcribe patient records and medical data. Assist in creating comprehensive medical reports and documentation. Ensure that records comply with relevant standards and regulations. Required Qualifications:. 1+ years of experience as a medical scribe or in medical transcription. Strong knowledge of medical terminology. Familiarity with electronic health record (EHR) systems. Why Join Us. Competitive pay (‚1200/hour). Flexible hours. Remote opportunity. NOTEPay will vary by project and typically is up to Rs. 1200 per hour (if you work an average of 3 hours every day that could be as high as Rs. . Shape the future of AI with Soul AI!.

: Job TitleClient Implementation Analyst, NCT LocationPune, India Role Description In accordance with Anti-Money Laundering , Banks are obliged to perform Know-your-client (KYC) reviews on all new clients they adopt. These checks and reviews are made in strict accordance with regulatory requirement and the banks internal policies. The project involves verification of the Client data, performing due diligence checks on the Clients, reviewing KYC documentation performing the risk assessment of the Client, liaising with the Business/Compliance, advising on KYC requirements and signing off on new client adoptions. What well offer you 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Accident and Term life Insurance Your key responsibilities Responsible for verification of Client data Perform due diligence of new and existing clients covering a wide range of different client types including; Listed and Regulated, small/medium/ large private and public companies as well as more complex structures such as; SPVs, Co-operatives, Foundations and Funds, Governments, Joint Ventures, etc. Verifying KYC documentation of the Clients to be adopted/reviewed Perform the risk assessment of the Client to be adopted/reviewed Signing off on new client adoptions and periodic reviews Manage New Client Adoption or Periodic Review stream, to ensure that all requests are approved in accordance with regulatory requirements and the banks internal policies Manage exception ensuring that all SLAs defined with the Business on timeliness and quality are adhered Your skills and experience Domain Skills 1 to 2 years of relevant work experience (AML/KYC/compliance related) within corporate financial services industry, Research/Analytics role in other Banks / KPOs etc Understanding of Control, Compliance, Investigation/chasing functions in banks Familiarity AML/KYC regulations and industry guidelines Ability to interpret regulatory guidelines and assessing risk scores and entity types Ability to interpreting alerts Ability to identifying trends and inconsistencies Understanding of end to end KYC process Communication and Reasoning skills Good German Language Skills Written & Verbal B2.2 level Good reading, comprehension and critical reasoning skills Good analytical writing skills Good communication skills to communicate at all levels - onshore & stakeholders Soft Skills Ability to work independently and take ownership Flexibility while handling multiple cases of varying priorities Graduates with good academic records Exposure to draft procedures based on policies formulated by the Bank's AML Compliance departments. Relevant KYC experience in any Financial Sector for a minimum of 2 years How well support you About us and our teams Please visit our company website for further information: https://www.db.com/company/company.htm

: 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 well offer you 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Accident and Term life Insurance 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 well support you 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.

: Job Title Regulatory Control Support Compliance Surveillance - Analyst Corporate TitleAssociate LocationMumbai, India Role Description The Compliance Surveillance function at Deutsche Bank is a global function which focuses on the post-event detection of market manipulation, insider trading and other risks as defined by established DB standards and regulatory requirements. The focal point of our activities is the monitoring of communication, voice, and trade data. The successful candidate will join the Compliance Surveillance function in Deutsche India Private Limited. The role involves working closely with colleagues to support the Germany region. What well offer you 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Accident and Term life Insurance Your key responsibilities Conduct daily surveillance - primarily on trade data - to detect potential breaches such as insider trading, market manipulative actions. Perform research and investigations within defined service levels to identify the reason for potential violations. Document research results and escalate violations and/or suspicious activity according to firm policy and regulatory requirements. Work with members of the broader Surveillance team (mostly the German Surveillance team) to identify, analyze, investigate, and resolve issues. Work on ad-hoc Surveillance tasks as needed. Your skills and experience Degree level preferably in finance or economics. Knowledge of Financial Markets and Financial Instruments and understanding of related risks (e.g., market abuse) as well as interest in financial news. At minimum two years of experience in Banking with exposure to Financial Instruments and / or Compliance. Fluent in spoken and written English. Being familiar with Mandarin or Cantonese is a plus. Strong attention to details, analytical skills and sound judgement. Team player with good communication skills with the ability to work independently. Proficiency in MS Office. How well support you