1759 Pharmacovigilance Jobs - Page 38

PV Reporting Associate ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Pharmacovigilance Associate to join our diverse and dynamic team. As a Pharmacovigilance Associate at ICON, you will play a vital role in monitoring and ensuring the safety of pharmaceutical products by collecting, analyzing, and reporting adverse event information. Your attention to detail and understanding of regulatory requirements will be essential in supporting the organization’s commitment to patient safety and compliance. What You Will Be Doing Collecting and reviewing adverse event reports to ensure accurate and timely reporting in accordance with regulatory guidelines. Conducting signal detection and risk assessment activities to identify potential safety issues. Collaborating with cross-functional teams to support safety-related inquiries and investigations. Maintaining up-to-date knowledge of pharmacovigilance regulations and industry best practices. Assisting in the preparation of safety reports and regulatory submissions. Your Profile Bachelor's degree in life sciences, pharmacy, or a related field; advanced degree preferred. Experience in pharmacovigilance, drug safety, or a related area, preferably within a clinical or pharmaceutical environment. Strong analytical skills with attention to detail in data collection and reporting. Excellent communication and interpersonal skills, enabling effective collaboration with team members and stakeholders. A commitment to maintaining high standards of quality and compliance in all pharmacovigilance activities. What ICON Can Offer You Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our Benefits Examples Include Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply Show more Show less

Job Title: Manager, Regulatory Data Introduction to role: Are you ready to make a significant impact in the world of regulatory data management? As a Manager, Regulatory Data at AstraZeneca, you will support data management, analysis, and quality control of regulatory data standards (XEVMPD, IDMP) and regulatory information. Join us in our mission to deliver life-changing medicines to patients around the world. Accountabilities: Perform operational activities for assigned elements of the regulatory information management process, XEVMPD, and the Global Product Registration List in accordance with quality control and quality improvement methodologies. Act as a Data Steward for assigned regulatory data assets, maintaining and managing regulatory data as per the Enterprise Data Quality Framework. Support the administration of regulatory data standards (XEVMPD, IDMP) and the processes used to govern the collection, coding, analysis, and quality control of regulatory information. Compile and deliver XEVMPD or other regulatory information-based submissions to health authorities. Develop expertise in critical topic areas such as technical skills (XEVMPD, IDMP), knowledge of international regulations, and other skills (communication, project management). Support changes based on intelligence about the regulatory environment and changes related to regulatory information practices. Provide operational support for new or optimized business processes to match environmental changes. Support continuous improvement initiatives. Prepare business reports, analyses, or alerts in response to business needs or health authority requests. Ensure collection and coding of regulatory information is done in compliance with regulatory and pharmacovigilance legislation, regulatory processes, and regulatory data standards. Review results of audits to ensure accuracy and compliance with regulations and procedures. Essential Skills/Experience: University degree in the life sciences Experience in pharmaceutical/medical industry Strong analytical and critical thinking ability Knowledge of pharmaceutical drug development process Good understanding of current regulatory legislation, guidelines, and trends relating to regulatory information management (process, tools, standards) Desirable Skills/Experience: Manages change with a positive approach to the challenges of change for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business. Excellent written and verbal communication skills, negotiation, collaboration, and interpersonal skills. Good problem and conflict resolution skills. Demonstrated ability to set and manage priorities, resources, performance targets, and project initiatives in a global and regional environment. Ability to thrive in a rapid-paced environment. When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. At AstraZeneca, we are driven by a bold ambition to eliminate cancer as a cause of death. Our Oncology Business Unit is dedicated to following the science and challenging the status quo to deliver more effective treatments to patients in need. We foster a culture of inclusion and belonging where everyone can bring their true selves to work. With access to industry-leading research, technology, and a game-changing pipeline, you will have the opportunity to make a real difference in the fight against cancer. Ready to take on this exciting challenge? Apply now and be part of our journey to change lives! Show more Show less

Job Title: Radiotherapy Technologist Company: Manipal Hospitals Location: Yelahanka Job Description: We are seeking a skilled Radiotherapy Technologist to join our team at Manipal Hospitals in Yelahanka. The successful candidate will be responsible for delivering high-quality radiation therapy to patients undergoing treatment for cancer and other medical conditions. You will work closely with radiation oncologists and other healthcare professionals to ensure effective treatment plans and patient safety. Key Responsibilities: - Operate and maintain radiotherapy equipment, including linear accelerators and other related devices. - Prepare patients for radiation treatment and explain procedures to ensure their comfort and understanding. - Position patients accurately and ensure correct radiation dosage is administered according to physician instructions. - Conduct quality assurance checks on equipment to ensure optimal functioning and compliance with safety standards. - Monitor and document patient's progress throughout the treatment process and report any changes to the healthcare team. - Maintain accurate and up-to-date patient records in compliance with hospital policies. - Adhere to infection control protocols and safety guidelines to ensure a sterile working environment. - Participate in continuing education and professional development to enhance skills and knowledge in the field. Skills and Qualifications: - Bachelor’s degree in Radiation Therapy or a related field. - Certification from a recognized professional body in Radiation Therapy. - Proven experience working as a Radiotherapy Technologist, preferably in a clinical or hospital setting. - Strong understanding of radiotherapy techniques and patient care protocols. - Excellent communication skills, with the ability to interact with patients and their families empathetically. - Attention to detail and strong organizational skills. - Ability to work effectively in a team and collaborate with healthcare professionals. - Proficient in using radiotherapy technology and computer software related to patient management. Tools and Equipment: - Linear accelerators - Radiation treatment planning systems - Imaging equipment (CT, MRI, etc.) - Patient monitoring systems - Electronic health record (EHR) systems - Quality assurance tools and testing devices We invite qualified candidates to apply and join our dedicated team at Manipal Hospitals, where you can make a difference in the lives of patients through effective radiotherapy treatment. Roles and Responsibilities About the Role: As a Radiotherapy Technologist at Manipal Hospitals, you will play a crucial role in the delivery of radiation therapy to cancer patients. You will operate advanced radiotherapy equipment, ensuring accurate treatment delivery and patient safety. Your responsibilities will include collaborating with oncologists and other healthcare professionals to develop and implement treatment plans. About the Team: You will join a dedicated team of healthcare professionals committed to providing high-quality cancer care. The team is composed of radiation oncologists, medical physicists, nurses, and other allied health staff who work collaboratively. This supportive environment fosters continuous learning and professional development. You are Responsible for: - Preparing and positioning patients for radiotherapy treatments to ensure accurate delivery. - Operating and maintaining radiotherapy equipment while adhering to safety protocols. - Conducting quality assurance checks to verify the accuracy and efficacy of treatment plans. - Maintaining detailed records of patient treatments and equipment performance. To succeed in this role – you should have the following: - A degree or diploma in Radiotherapy Technology from a recognized institution. - Proficiency in operating radiotherapy equipment and understanding treatment planning systems. - Excellent communication and interpersonal skills to effectively interact with patients and team members. - Strong attention to detail and a commitment to patient safety and care standards.

Role: Oracle Argus Developer Required Technical Skill Set: Argus LSMV ArisG Experience: 5+ Yr Work Location: Kolkata & Delhi NCR Desired Competencies (Technical/Behavioral Competency) Must-Have: Develop and configure ArisG LifeSphere Multivigilance solutions to meet business requirements Customize and extend the functionality of the ArisG LifeSphere platform using APIs and SDKs. Collaborate with pharmacovigilance experts and stakeholders to understand user requirements and design appropriate solutions Implement data integrations with other systems such as electronic health records (EHR) and clinical trial management systems (CTMS) Design and implement workflows for case processing, signal detection, and regulatory reporting Perform system maintenance and troubleshooting to ensure the stability and performance of the ArisG LifeSphere platform. Provide technical support and training to end-users as needed. Proficiency in programming languages such as Java, JavaScript, or SQL. Experience working with the ArisG LifeSphere platform and its various modules (e.g., Multivigilance, Signal Management, Aggregate Reporting) Familiarity with pharmacovigilance regulations and guidelines (e.g., FDA, EMA, ICH) Strong analytical, interpersonal communication skills Good knowledge of SDLC / ITIL processes Ability to work effectively in a fast-paced environment and manage multiple projects simultaneously. Good-to-Have: Certification in ArisG LifeSphere administration or development Experience with other pharmacovigilance software platforms such as Oracle Argus or IBM PV. Knowledge of data analytics and visualization tools. Understanding of database design and management concepts. Familiarity with cloud computing platforms like AWS/Azure. Responsibility of / Expectations from the Role Designing and development and Migration activities Handling tickets and change management activities Daily interaction with customer and coordination between different team Mentoring team Show more Show less

Work Schedule Environmental Conditions At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. Our detailed, goal-oriented Pharmacovigilance colleagues manage the safety profile of new drugs in clinical trials, oversee case-processing activities through all phases of development and perform regulatory reporting and medical monitoring. As part of your work with beginning-to-end trial experience, you will expand your knowledge and experience working on clinical trials through every stage of drug development. This includes management and oversight of all contracted services. Discover Impactful Work: As a Safety Reporting Specialist, you will be responsible for receipt, submission, and subsequent tracking of expedited and periodic safety reports pertaining to the department’s projects. You will assist management in producing project metrics as required. You will also be involved in projects and programs relating to safety reporting and may take a lead role on projects. A day in the Life: Receives, prepares and submits safety reports to applicable parties. Escalates to lead and/or line manager if any issues are encountered. Ensures reports are submitted in compliance with regulatory timelines and country legislation. Assists in producing metrics and alerts manager to any quality or timeline issues. Participates on project teams and may lead projects of small to moderate scope. Provides training and support to other team members. Performs administrative tasks such as filing and the maintenance of safety reporting systems and information. Liaises with various departments around safety reporting tasks and the setting up of client accounts. Participates in audits where required and performs testing activities as needed. Shares ideas and suggestions with team members ensuring effective communication and participates in process improvement initiatives. Keys to Success: Education Bachelor's degree or equivalent and relevant formal academic / vocational qualification Experience Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’) In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills, Abilities Strong knowledge of medical terminology Good written and verbal communication skills Good Microsoft Word and Excel skills and solid understanding of safety database functionality Solid knowledge of procedural documents and working knowledge of global safety reporting requirements (including FDA regulations and guidelines) Ability to juggle multiple tasks while still delivering high quality results Strong attention to detail and accuracy with orientation toward careful and meticulous work Possess the maturity to handle sensitive information and data effectively Ability to interact effectively with all levels of the organization Strong critical thinking and problem-solving skills Work Environment Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary for typical working hours. Ability to use and learn standard office equipment and technology with proficiency. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. May require travel. (Recruiter will provide more details.) Show more Show less

About The Role Credit Card Process Manager Marketing HO Department Credit Card Products Location Infiniti IT park Reporting Relationship Position Grade Senior Manager Job Role Process designing for Credit Cards covering key aspects of Process Workflows (Digital / Physical), Compliance, Risk, Legal, Ops, Customer Experience, etc. Creating and documenting SOPs/Process notes of various Credit Card processes with clear defined roles and responsibilities to promote efficient implementation. Ability to think through end to end process at various touchpoints such as online channels, partners, Branches, Call center etc. Review processes in light of Fraud and Risk raised by RCU and ORM. Identification of Risks and Regulatory breach on cards processes and provide solution to mitigate risks and control reports to minimize process lapses. Monitor and govern if the defined processes are being executed from time to time, including regulatory changes In-depth understanding of KYC and Other Regulatory Guidelines. Providing tailor made solution to Product / Operations for specific business requirement. Ideate & suggest Product and Operations with end to end execution of a Process / Digital Journey"™s / new initiatives / features etc. Ensuring the Digital Journey controls and logics is in line with defined Process, Regulation and Risk perspective Responsible for the documentation of Business Processes, workflows. Publish MIS and Reports Job Requirement Graduate/Post-Graduate with at least 5 to 6 years of experience in Business Processes In-depth knowledge of Credit Cards business Knowledge of Regulatory requirements and market competition/intelligence will be an added advantage. Excellent communication skills Verbal & Written Good Logical reasoning and data analysis skill Should be able to think proactively for process changes from Business Process Re-engineering perspective Assertive attitude Self-Driven and ability to follow-up promptly Good analytical skills & eye for details

Overall Mission This position typically refers to any employee within the EPD Medical organization with medical/scientific qualifications and training who provides scientific/medical support to EPD in a non-sales capacity, where the provision of such scientific/medical support includes significant contact with Abbott customers in the field. This definition is not intended to apply to those employees whose primary job function relates to the monitoring or management of clinical studies. Reporting into the Senior Manager RMA / Head RMA this position participates in the initiation, oversight and follow-up of assigned clinical studies and medical projects initiated within the EPD Medical Organization, ensuring that activities are carried out in accordance with relevant processes and procedures. The RMA interfaces with other key members of the EPD Medical Organization - for example, Medical Managers, Clinical Research Managers and Medical Advisors - relevant to the therapeutic area for which the RMA has responsibility. The RMA assists relationships and advances the scientific credibility of the Company with established and emerging Regional/National Opinion leaders, responds to requests for scientific and medical information, and provides key scientific information updates to Regional and National Opinion leaders, as appropriate. The RMA develops, and maintains, key scientific knowledge that will enable credible dissemination of scientific information and informed scientific dialogue with physicians and opinion leaders, and the development of professional working relationships. Job Responsibilities Ensure that all activities and interactions are conducted with due regard to all applicable local, global and national laws, regulations, guidelines, codes of conduct, Company policies and accepted standards of best practice. Provide scientific and technical support for, and help maintain professional and credible relationships with, key opinion leaders and academic centers to ensure access to current medical and scientific information on the products and areas of therapeutic interest. Ideate, design, develop and deliver innovative and engaging high science activities for Physicians and Key Opinion Leaders, to help drive Therapy Shaping in the area the RMA is assigned to, in collaboration with the Medical Affairs & the Commercial team. Assist in the initiation, oversight and follow up of assigned clinical studies and medical projects initiated within the relevant therapeutic area for which the RMA carries responsibility (e.g. post marketing clinical activities such as registry/database projects, epidemiological surveys, post-authorization studies (phase IV), IIS projects, etc.): all activities to comply with applicable local laws, guidelines, codes of practice, SOPs, and, I& D * SOPs. Deliver high science, unbiased and accurate scientific presentations to physicians, individually or in groups (meetings, clinical sessions, etc.), when requested. Participate in the selection process to identify appropriately qualified physicians the Company would wish to engage in collaborative efforts – such as potential research collaborations, or lecture/meeting support (Round Tables, Congresses, Symposia, etc.); and to ensure a high level of scientific or educational integrity in these collaborative efforts. Develop awareness and understanding of competitor issues/intelligence – for example, product strategies, studies, commercial messages, positioning, etc – and communicate, where appropriate, within the Company. Continuous and consistent support to the Medical / Marketing teams in gathering Insights and feedbacks from HCPs and Patients for more impactful brand plans / New products Attend relevant Scientific Societies meetings and Conferences, and develop summaries of key messages for use within the Company – such as key areas of scientific/company interest, new trends in diagnosis, monitoring and treatments in the therapeutic area, etc. Upon request, assist physicians to appropriately direct requests for access to Company products on a named patient or compassionate use basis, subject to all applicable legal and regulatory requirements. Support sales/marketing/internal team areas to develop their scientific and technical expertise through the delivery of scientific update presentations. Ensure up to date knowledge of products uses and external data. Provide key opinion leaders and internal medical and clinical teams with scientific and technical support for publications of scientific or medical interest. Support in Digital engagement of HCPs & patients through specific programmes as and when required Participate along with Medical Affairs & Clinical Operations team in real world data collection programmes Technical Competencies Therapeutic Area Expertise Management Skills Communication Skills Compliance & Process Improvement Skills Problem/Conflict Solving Ability Priority Setting Relationship Building Required Core Competencies / Attributes Adaptability: Maintain effectiveness when experiencing major changes in work tasks or the work environment; adjust effectively to work within new work structures, processes, requirements, or cultures. Consider change or new situations as opportunities for learning and growth. Persevere when encountering adversity. When confronted with a problem or crisis consider alternatives and then take timely action. Effectively prioritize work tasks. Initiative: Take prompt action to accomplish objectives; is proactive. Maintain a strong focus on internal and/or external customers. Continuously monitor relevant information, key issues and/or trends. Proactively seek feedback and adapts behavior to improve performance. Demonstrate a willingness to learn new aspects of the business. Display Ownership for end to end execution of initiatives. Innovation: Generate innovative solutions in work situations; try different and novel ways to deal with work problems and opportunities. Use best practice and benchmark data to increase organizational performance. Identify opportunities to improve efficiencies and reduce costs. Integrity: Firmly adhere to codes of conduct and ethical principles. Exhibit honesty. Present information accurately and completely. Keep commitments to work colleagues and customers. Acknowledge and respond constructively to failure and mistakes. Teamwork & Collaboration: Work effectively and cooperatively with others; establish and maintain good working relationships with internal and external partners to facilitate the accomplishment of work goals. Help others achieve shared goals. Demonstrate a willingness to listen without interrupting. Open to diverse and different ideas. Competencies ADAPTABILITY Responds to changes in the business and clinical practice within the country; considers the impact of these changes on the assigned product(s) and therapeutic area(s) and recommends ways to take advantage of new opportunities or counter threats to the business. INITIATIVE Develops awareness and understanding of competitor issues/intelligence and communicates this information, where appropriate, within the affiliate. Applies therapeutic area knowledge to recommend clinical studies and other medical projects that will strengthen the position of assigned product(s). INNOVATION Helps develop EPD strategy by identifying future opportunities for the assigned product(s) and therapeutic areas(s) and works with HQ, Area and Affiliate colleagues to take advantage of those opportunities. INTEGRITY Ensures that all activities and interactions are conducted in accordance with all applicable local, global and national laws, regulations, guidelines, codes of conduct, company policies and accepted standards of best practice. TEAMWORK & COLLABORATION Supports sales/marketing/internal Affiliate teams to develop their scientific and technical expertise. Participates in the selection process to identify appropriately qualified physicians the Company would wish to engage in collaborative efforts. Technical Competencies THERAPEUTIC AREA EXPERTISE Maintains an up-to-date scientific knowledge of assigned product(s) uses and key external data. Provides scientific support for, and helps maintain professional and credible relationships with, key opinion leaders and academic centers to ensure access to current medical and scientific information on the assigned products and areas of therapeutic responsibility. Supports sales/marketing/internal Area teams to develop their scientific and technical expertise through the delivery of scientific update presentations, and periodic training as required. Management Skills Uses resources effectively and efficiently. Able to plan, prioritize and delegate tasks to project team as needed to ensure timely completion of projects. Maintain and operate within budget. Capable of analyzing and investigating issues and problem solving. Communication Skills Effectively practices listening skills before responding to issues. Effectively writes, presents and communicates information to internal and external clients, including divisional management. Effective negotiation skills. Compliance & Process Improvement Skills Demonstrates the ability to exercise good judgment on regulatory compliance issues. Demonstrates an understanding of the appropriate regulatory requirements and applies this understanding to all job responsibilities. Able to insure compliance to regulations from direct reports and outside contractors (CRO). PROBLEM/CONFLICT SOLVING Able to analyze situations and conflicts without pre-judgments and assumptions Listens carefully and with an open mind Provides direct, complete, corrective and actionable feedback Reads situations quickly Settles disputes Negotiates common ground for win/win solutions PRIORITY SETTING Prioritizes activities and projects, in order to better spend own time and others for what would provide the optimum return to the organization. Quickly senses what will help or hinder accomplishing a goal Eliminates roadblocks Relationship Building Builds credible, meaningful & deep relationships with internal and external stakeholders Is sensitive towards unmet needs of internal and external customers Key Interfaces EPD medical personnel: Clinical Research Managers, Clinical Operations Managers, Medical Advisors; Medical Information team / specialists; EPD Pharmacovigilance / drug safety personnel Marketing department across therapeutic area Sales organization of the geographic area of responsibility. Administrative personnel of the Medical Department and of the Business Unit. Healthcare personnel (including; physicians, nurses, pharmacists). Patients (through Patient Awareness Programs) Participating Research Investigators Key Opinion leaders Institutions and Scientific or Medical Societies International Medical Development / Global Project Team (GPT) personnel Authority And Reporting Lines This position reports into the medical department- - Senior Manager RMA / Head RMA LOCATION: This function is field based. Ideal Candidate Criteria Graduate or Post Graduate Medical Degree in Pharmacology (Preferable) or Allied Sciences Keen interest in developing and maintaining expert knowledge for assigned therapeutic area/product and in medical research in general. Knowledge of the scientific methods applied to clinical research and the current legislative/regulatory controls. Solid knowledge of the pharmaceutical environment and excellent skills to build stake-holders relationship. Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity. A good command over spoken and written English Career Development Possible career development roles: Manager-Medical Affairs or Medical Advisor Head of Affiliate Medical Area Medical Advisor EPD Strategic Medical Affairs Clinical Development, GPRD, I & D Product Management Show more Show less

Job Description Job Description Senior Specialist, Medical Affairs Our Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry leaders ensuring the scientific value of our products is understood. We connect, communicate and train internal employees to ensure a thorough understanding of the science behind the medicine and review further unmet medical needs to support collaboration to further differentiate our portfolio. THE OPPORTUNITY The Senior Medical Advisor (SMA) is primarily responsible for developing and implementing Medical Affairs Plans for their designated assets within the country. Their role involves facilitating the exchange of medical and scientific information between peers and key stakeholders, both internal and external. The SMA serves as an important collaborator on cross-functional teams that include Marketing, Training, Market Access, and Policy. They are tasked with proposing concepts for local data generation studies and, if these are prioritized and funded, securing approval from headquarters through the proper governance channels. The SMA is accountable for the timely execution, analysis, and publication of local studies. They foster trust with the external scientific community by engaging with scientific leaders and organizing country expert input forums to stay informed on advancements in therapy and patient care. Additionally, they effectively collaborate and lead efforts to address regulatory, reputational, ethical, and other asset management challenges within the country. WHAT YOU WILL DO Therapy Area to be handled will be Vaccines Primary Activities – Accountabilities, Supervision Asset Management & Business Leadership Gather actionable medical insights from the country that can inform the company’s strategic decisions. Convert the Global Medical Goals and Strategies into research initiatives, data analysis, scientific communication, educational efforts, and other tactics that aim to improve patient outcomes and enhance accessibility within the country. Follow up on investigator-initiated study proposals that align with the our company Investigator Study Program (MISP) areas of interest, adhering to the guidance outlined in the MISP Manual. Assist in executing the tactical plan and quickly adjust it to align with the business realities in the country. Operate with ethics and integrity by providing non-promotional, balanced, reliable, and scientifically sound information, while strictly adhering to company standards and local regulations. Scientific & Technical Leadership Integrate the insights of the country’s scientific and healthcare environment into the Regional Medical Affairs Team. Clearly and credibly communicate both scientific and business requirements to a wide variety of internal and external stakeholders at all levels. Build trust with the external scientific community through peer-to-peer exchanges, collaborative research, educational partnerships, interactions with scientific societies and health organizations, publications, and other related efforts. Deliver therapeutic and functional training to assigned teams and affiliate functions. Design and execute medical educational programs and symposia tailored to the country. Organize expert input forums within the country to inform and influence company strategy. Engage actively and contribute meaningfully to professional organizations, as well as academic and regulatory working groups. Regulatory Management Successfully collaborate and lead resolution of Regulatory, Reputational (i.e. Public Relations), Compliance and other Asset issues management Collaborate in the successful management of asset safety or quality issues, i.e. contribute content and strategy in regulatory responses and interactions, risk management planning and implementation Medical Information Provide prompt medical information support, such as research and answering of medical inquiries from external and internal customers, and review/approval of local response documents. About You Skills, Knowledge, Experience & Qualifications required MD, PhD, degree is required; recognized expertise through 5-10 years. Medical Affairs, Clinical and/or research experience, pharmacovigilance, governance and scientific leader management in the therapy area (Vaccines) is desired. Experience in launching innovative products, managing their life cycles, and understanding local pharmaceutical industry guidelines, as well as regulatory and reimbursement frameworks and clinical research guidelines. Strategic thinking skills, particularly concerning asset value proposition and evidence related to clinical and value-based outcomes. Ability to build a network of scientific leaders and successfully engage with other key stakeholders, including public groups, government officials, and medical professional organizations within various therapeutic areas. Desired experience in advocating for patient populations and improving healthcare access. Involvement in pursuing consensus recommendations and country-specific guidelines for various medical societies is preferred. Demonstrated capability to effectively communicate information at the country management level, with public groups, and to scientific leaders. Strong interpersonal, analytical, communication (both written and verbal), and project management skills that are results oriented. Excellent prioritization skills and an understanding of how decisions align with broader corporate strategies. Ability to collaborate effectively across functions in a matrix environment to achieve successful outcomes. Desired competency in budget management. Our Company Leadership Standards Applicable To The Role Include Make Rapid, Disciplined Decisions - Make timely decisions at the right level with the right data and support them once made. Act with Courage & Candor - Speak openly, honestly and with conviction have the courage to take appropriate risks and make difficult decisions. Demonstrate Ethics & Integrity - Adhere to the highest standards of trustworthy and ethical behavior in all interactions and hold others to the same standards; comply with all laws, policies and regulations; identify and address ethical issues without hesitation. Foster Collaboration - Actively listen and seek to understand differing perspectives; work together to achieve the common goals of the new to our company. Focus on Customers & Patients - Focus the entire organization on delivering value for customers, including patients, by understanding and meeting their needs. Drive Results - Set clear performance standards; overcome obstacles; hold our-selves and others accountable for achieving results. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status Regular Relocation VISA Sponsorship Travel Requirements Flexible Work Arrangements Not Applicable Shift Valid Driving License Hazardous Material(s) Required Skills Preferred Skills Job Posting End Date 07/15/2025 A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID R338824 Show more Show less

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 Position Summary This role requires working as part of the Safety System Administrator Team performing database administration activities; supporting creation and upgrade of database instances; change control and data migration activities; first line user support and troubleshooting; and training users on databases. Principal Responsibilities The Safety System Administrator is primarily responsible for: Maintenance of database libraries Involvement in system validation activities Interrogating the database and generating outputs for internal and client use Training and providing database access to internal and client users Principle Functions For the Client (may include but is not limited to the following) Set up and maintenance of project specific database libraries including: Products Licenses Studies Reporting destinations Documenting and validating any change to the project specific database Support during legacy data transfer e.g., validation Supporting/providing guidance to the Project Manager / Client / Project Start Up Team during the development of project specific data handling guidelines (to ensure project specific guidelines are necessary and will not impact line listings and report generation) Prepare line listings and tabulations and other database outputs for use in aggregate reports, signal detection, reconciliation and other activities as required Provide case processing metrics required for invoicing (e.g., number of submissions, number of spontaneous vs initial cases processed) Provide database training to clients Providing and documenting client / internal team access upon receipt of an approved access request. For the Company (may include but is not limited to the following) Coordinate user access (including maintenance and revoking access) Maintain database procedures including core data handling conventions Provide database training and certification to PrimeVigilance users Provide user support Involvement in root cause investigation of database related deviations and ensure timely and complete documentation of resulting actions in line with Quality procedures Provide case processing quality and compliance metrics to the Quality Team Identify areas for improvement and address via training, clarifying changes to data handling guidelines, user guides etc. Execute business continuity periodic testing for database failure Ensure that existing software bugs, user requests, changes to regulatory requirements etc., are considered and appropriate changes are made and validated as required Support IT, database vendor and technical colleagues in troubleshooting and implementing software fixes and enhancements as required Other Supportive Responsibilities Assist PrimeVigilance senior management on an as needed basis. Potentially provide chargeable consulting / training activities to clients regarding Argus, and if required LSSMV. Qualifications Educated to degree standard Demonstrated work experience within Argus Safety Systems. 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 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! We look forward to welcoming your application. 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 Quality Integrity & Trust Drive & Passion Agility & Responsiveness Belonging Collaborative Partnerships Show more Show less

Primary Responsibilities: Review and analyze patient medical records for accurate code assignment Ensure adherence to coding guidelines and regulatory requirements Learn to use medical coding software Apply understanding of anatomy and physiology to interpret clinical documentation and identify applicable medical codes Stay updated on industry changes and attend relevant training sessions Ensure confidentiality and security of all patient information 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 #NTRQ Required Qualifications: Bachelors degree or masters degree, from a medical science backdrop or anything relevant Life Science or Bioscience, Pharmacy or Pharmaceutical Sciences, Nursing or Medicine Allied Health Good knowledge in medical terminology basics Good knowledge in Anatomy physiology basics Well-versed with ICD-10 guidelines and their implementation Proficient in reviewing medical records and determining the accuracy and completeness of the document Preferred Qualifications: AAPC/AHIMA Certification Risk Adjustment coding experience 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.

Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need to feel their best. Here, you will find a culture guided by diversity and inclusion, talented peers, comprehensive benefits and career development opportunities. Come make an impact on the communities we serve as you help us advance health equity on a global scale. Join us to start Caring. Connecting. Growing together Primary Responsibilities: Review and analyze patient medical records for accurate code assignment Ensure adherence to coding guidelines and regulatory requirements Learn to use medical coding software Apply understanding of anatomy and physiology to interpret clinical documentation and identify applicable medical codes Stay updated on industry changes and attend relevant training sessions Ensure confidentiality and security of all patient information 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 #NTRQ Required Qualifications: Bachelors degree or masters degree, from a medical science backdrop or anything relevant Life Science or Bioscience, Pharmacy or Pharmaceutical Sciences, Nursing or Medicine Allied Health Good knowledge in medical terminology basics Good knowledge in Anatomy physiology basics Well-versed with ICD-10 guidelines and their implementation Proficient in reviewing medical records and determining the accuracy and completeness of the document Preferred Qualifications: AAPC/AHIMA Certification Risk Adjustment coding experience 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.

Primary Responsibilities: To be an effective participant in Class room training and clear the training assessments with 85% quality Consistently meet the targets set for MOCK charts Eligible employee will get confirmed as Junior Coder within a max of 6 months from the Joining Punctuality, Attendance and General Adherence to company policies, procedures and practices Strives to provide ideas to constantly improve the process Ensure adherence to external and internal quality and security standards (HIPPA/ISO/ISMS) Be an effective team player 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 #NTRQ Eligibility To apply to an internal job, employees must meet the following criteria: SG 22 can apply will move laterally Performance rating in the last common review cycle of Meets Expectations or higher Not be on any active CAP (Corrective Action Plan) or active disciplinary action Time in Role Guidelines Should have been in your current position for a minimum of 12 months, if you have not met the recommended minimum time in role, discuss your career interest with your manager and gain alignment prior to applying. And share the alignment email with respective recruiter while applying Required Qualifications: Any degree in Life Science or Bio-Science Any degree in Pharmacy or Pharmaceutical Sciences Any degree in Nursing or Allied Health Any degree in Medicine 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.

Job DescriptionJob Description Responsible for assisting Project Management personnel with various tasks throughout the study lifecycle. ESSENTIAL DUTIES AND RESPONSIBILITIES: Assist with the Planning and Setup, Monitoring, and Closeout Phases of study management which may include: Database setup. Study documentation development. Equipment distribution/tracking. Report creation/distribution. Archival of study documentation. Coordinate Project Assurance meetings and assist with compiling meeting minutes and action items. Support financial components of study management including: Assistance with documentation/database updates due to scope changes. Follow-up related to invoice reconciliations. Preparation of reports in support of study forecasting activities. Facilitate issue management by documenting and tracking progress to ensure timely resolution to customer escalations. OTHER DUTIES AND RESPONSIBILITIES: Ensure compliance with timely training completion/documentation. Respond to customer inquiries and participate in customer calls/meeting upon Project Managers request. Take the lead in managing various aspects of a project as requested. Other related projects and tasks as assigned. QUALIFICATIONS AND SKILLS NEEDED: Education : Bachelor Degree preferred. Experience : At least 1-3+ years of experience in pharmaceutical field (or related industry experience). Knowledge of the drug development process. Good organizational, interpersonal, time management, and prioritization skills Excellent verbal and written communication skills, including ability to communicate effectively in English. Detail oriented and responsive to inquiries and requests. Working knowledge of Microsoft Office products.

General Summary: Provide financial analysis, modeling and research in support of potential real estate investment opportunities including acquisitions, dispositions and structured finance investments, as well as assist in the preparation of presentations to Investment Committee. Key Duties and Responsibilities: Create dynamic underwriting models in Excel with detailed property level cash flows in support of potential investment decisions; Prepare industry related research and analysis; Assist in preparation of memorandums and presentations to the Executive team; Work with various departments including legal, accounting, leasing, and property management to aggregate, interpret, and share information used to communicate both externally and internally for potential investments; Provide other support to the Investments team as needed. Job Specifications: BA/BS in finance, economics, accounting or related field, with up to six years of commercial real estate, corporate finance, or investment banking experience. Experience with Argus a must. Strong experience modeling real estate transactions with an in depth understanding of real estate fundamentals. Ability to understand and analyze financial statements (GAAP), leases, and related documents for purposes of forecasting, underwriting, and analyzing tenant credit quality. Organized and task oriented, able to work in a fast-paced, team-oriented environment with multiple deadlines, and adapt readily to changing priorities. Ability to convey technical information orally and in written correspondence, reports and presentations in a clear and concise manner. Highly skilled in Microsoft Excel and PowerPoint.

Medical Coding is the process of converting Verbal Descriptions into numeric or alpha numeric by using ICD 10-CM, CPT && HCPCS. As per HIPAA rules healthcare providers need efficient Medical Coders. Qualification & Specifications : MBBS,BDS,BHMS,BAMS,BSMS,PHARMACYB.Sc/M.Sc (Life Sciences / Biology / Bio Chemistry / Micro Biology / Nursing / Bio Technology), B.P.T, B.E BIOMEDIAL, B.Tech (Biotechnology/Bio Chemistry). 2020 -2024 passed out Skills Required: * Candidates should have Good Communication & Analytical Skills and should be Good at Medical Terminology (Physiology & Anatomy). Role: To review US medical records Initial file review for identifying merits Subjective review and analysis to identify instances of negligence, factors contributing to it To review surgical procedures, pre and post-surgical care, nursing home negligence To prepare medical submissions To prepare the medical malpractice case Regards Kowshika 7200652461

Urgent Walk in For M.Pharmacy fresher who are specialized in quality assurance only Eligible Developing and Implementing QA Systems and Procedures: Knowledge of quality assurance systems, and procedures creating SOPs (Standard Operating Procedures) Required Candidate profile Strong knowledge of cGMP and relevant regulatory requirements: This includes understanding manufacturing processes, quality control procedures, and validation requirements.

Company Description PrimeVigilance (part of Ergomed Group) is 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 becoming one of the global leaders in its fields. 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. Job Description The Financial Project Analyst has wide ranging responsibilities of PFA related duties. Work with Project Management Team to accurately forecast future units and revenue. Manage the financial health of our projects, working closely with the project to team to accurate record all financial data, report financial data clearly to the Project team. Monitor the total project cash positions. Responsible for all the financial aspects of assigned projects Ongoing maintenance of the financial and operational data within the companies’ management information structure Creation and distribution of scheduled reports Complete month end responsibilities including revenue recognition and forecasts, variance analysis, profitability analysis, and any other reporting needs as required Support Proposals & Contracts and Project Directors on the development of financial analysis for proposals Work closely with the Project Manager to provide on-going financial resource planning, management and analysis Supports the overall health of assigned projects Perform ad hoc financial analyses as requested by Project Managers and/or Department Heads Qualifications BA/BS degree in Business, Accounting, Finance, or equivalent education and experience. Demonstated relevant finance or accounting experience, project accounting/analysis a plus Pharmaceutical or CRO experience is preferable Strong proficiency in English Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) is essential Proficiency with accounting software packages Experience with Oracle Finance is preferred Knowledge in financial modelling techniques Excellent analytical skills Additional Information 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. Show more Show less

Job Title - Life Sciences- Clinical Management Level : 9,11 Location: HYD, BLR, GGN, MUM; Must have skills: Working knowledge of clinical data management platforms such as Medidata/ RAVE, Veeva Clinical suite Good to have skills: Preferably worked with R&D functions such as Laboratory functions (R&D and Quality Check labs), clinical operations and development, decentralized clinical trials Job Summary: MBA from a Tier 1 institute or rich relevant industry experience 6+ years of progressive business and/or consulting experience; at least 1 year of experience in Life Sciences industry is mandatory Management consulting and general business consulting experience is a must Familiarity with assets OR tools in business consulting (R&D), such as issue trees, implementation frameworks, diagnosis tools like client questionnaire and analysis, operating model, business process mapping, and so on. Preferably worked with R&D functions such as Laboratory functions (R&D and Quality Check labs), clinical operations and development, decentralized clinical trials, pharmacovigilance, regulatory, quality management system, in capacity of a business analyst or management consultant. Working knowledge of clinical data management platforms such as Medidata/ RAVE, Veeva Clinical suite, pharmacovigilance databases ArisG & ARGUS databases, Regulatory Information Management Systems (Veeva RIM), lab informatics is desirable Roles & Responsibilities: Together, let’s deliver more effective, affordable, personalized patient outcomes. In this practice, you’ll help drive our Life Sciences clients’ strategy and business planning efforts, with the following initiatives: Support delivery of small to medium-size teams to deliver management consulting projects for global clients. Responsibilities may include strategy, implementation, process design and change management for specific modules Support efforts global sales team to identify and win potential opportunities within the practice. Provide industry expertise in various sub-segments of the LS industry Develop assets and methodologies, point-of-view, research or white papers for use by the team and larger community. Acquire skills that have utility across industry groups. Support on strategies and operating models focused on some business units and assess likely competitive responses. Also, assess implementation readiness and points of greatest impact. Co-lead proposals, business development efforts and coordinate with other colleagues to create consensus-driven deliverables. Execute a transformational change plan aligned with client’s business strategy and context for change. Engage stakeholders in the change journey and build commitment for change. Acquire skills that have utility across industry groups. Professional & Technical Skills: Bring your best skills forward to excel in the role: Industry expertise with a global top pharmaceutical, medical devices or biotechnology firm Familiarity or expertise with assets or tools in business consulting such as issue trees, implementation frameworks, diagnosis tools like client questionnaire and analysis, operating model, business process mapping, and so on Good functional and domain knowledge with relevant experience in the same area Make presentations wherever required to a known audience or client on functional aspects of his or her domain Should have worked with multi-functional teams and cross-functional stakeholders Ability to solve complex business problems and deliver client delight Strong writing skills to build point of views on current industry trends Strong program management skills Good analytical and problem-solving skills with an aptitude to learn quickly Good communication, interpersonal and presentation skills Additional Information: What’s in it for you? An opportunity to work on transformative projects with key G2000 clients Potential to co-create with leaders in strategy, industry experts, enterprise function practitioners and, business intelligence professionals to shape and recommend innovative solutions that leverage emerging technologies. Ability to embed responsible business into everything—from how you service your clients to how you operate as a responsible professional. Personalized training modules to develop your strategy & consulting acumen to grow your skills, industry knowledge and capabilities Opportunity to thrive in a culture that is committed to accelerate equality for all. Engage in boundaryless collaboration across the entire organization. About Accenture: Accenture is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions — underpinned by the world’s largest delivery network — Accenture works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With 569,000 people serving clients in more than 120 countries, Accenture drives innovation to improve the way the world works and lives. Visit us at www.accenture.com About Accenture Strategy & Consulting: Accenture Strategy shapes our clients’ future, combining deep business insight with the understanding of how technology will impact industry and business models. Our focus on issues such as digital disruption, redefining competitiveness, operating and business models as well as the workforce of the future helps our clients find future value and growth in a digital world. Today, digital is changing the way organizations engage with their employees, business partners, customers and communities. This is our unique differentiator. To bring this global perspective to our clients, Accenture Strategy's services include those provided by our Capability Network – a distributed management consulting organization that provides management consulting and strategy expertise across the client lifecycle. Our Capability Network teams complement our in-country teams to deliver cutting-edge expertise and measurable value to clients all around the world. For more information visit https://www.accenture.com/us-en/Careers/capability-network Accenture Capability Network | Accenture in One Word At the heart of every great change is a great human. If you have ideas, ingenuity and a passion for making a difference, come and be a part of our team. About Our Company | Accenture Experience: 3+ years of progressive business and/or consulting experience; at least 1 year of experience in Life Sciences industry is mandatory Educational Qualification: MBA from a Tier 1 institute or rich relevant industry experience Show more Show less

About the Company Qinecsa is a trusted, global partners bringing together best-in-class technology and scientific expertise to connect life science companies, public health, and regulatory sectors to the right safety solutions. we take pride in being the leading specialist pharmacovigilance provider, offering unparalleled expertise in PV services, technology, and consulting to cater to the unique needs of small, medium, and large pharmaceutical companies Location: India Job Type: Full-Time Job Description: We are seeking a Consulting Technology Project Manager to manage client implementation projects for our Pharmacovigilance SaaS solutions. The ideal candidate will be a dynamic client facing services professional with extensive project management experience in the life science technology domain. This is a strategic role requiring deep project management expertise, pharmaceutical domain knowledge, and excellent leadership skills. Key Responsibilities: Lead end-to-end project management of client software implementations, upgrades, and integrations. Develop and manage project plans, including timelines, budgets, and resource demand, and author project initiation documents. Coordinate cross-functional, global teams to ensure successful project delivery. Serve as the primary point of contact for senior client stakeholders, ensuring clear communication and strong relationship management. Ensure the accuracy, reliability, and performance of all project deliverables. Monitor project progress and performance, identifying and mitigating risks and issues as they arise. Facilitate regular project status meetings and provide updates to stakeholders. Actively manage project scope and costs, ensuring any changes are documented and approved through formal change control processes. Develop and maintain comprehensive project documentation, including project initiation documents, risk management plans, and post-project reviews. Ensure all projects comply with industry regulations, particularly those related to pharmacovigilance and data privacy (e.g. GxP, GDPR). Coordinate and manage interactions with third-party vendors, consultants, and partners to ensure successful delivery and integration of external components or services. Support continuous improvement of project management processes, tools, and best practices within the organization. Mentor and guide junior project managers and team members, fostering a collaborative and high-performance team environment. Characteristics: Well-organized self-starter with attention to detail. Excellent client facing communication and problem-solving skills. Strong written, communication, and interpersonal skills. A desire to learn about our proprietary products Essential Experience and Qualifications: Bachelor's or Master's degree in Computer Science, Information Technology, Project Management, or a related field. 8+ years of experience in project management, with at least 5 years in a senior or lead role delivering software solutions to pharmaceutical or life sciences clients. Proven experience managing pharmacovigilance, clinical, or regulatory technology projects. Knowledge of pharmacovigilance workflows and regulatory standards (e.g., ICH E2E, GVP Modules, FDA, EMA). Expertise in project management methodologies (e.g., Agile, Scrum, Waterfall). Proficiency in project management tools (e.g., Microsoft Project, Jira, SmartSheet). Preferred Experience and Qualifications: Familiarity with signal detection, case management, and safety databases (e.g., Argus, ARISg). Familiarity with cloud-based solutions and big data technologies. Technical background with experience in software development or IT infrastructure. Knowledge of regulatory requirements and industry standards for technology solutions. Certification in project management (e.g., PMP, PRINCE2). What We Offer: Competitive salary Opportunity to work with a dynamic and innovative team and world-class clients. Professional development and growth opportunities. A collaborative and inclusive work environment. Work from home with limited travel. How to Apply: Interested candidates are invited to submit their resume and cover letter to roopa.shree@qinecsa.com Show more Show less

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

Description Safety Physician - ICSR Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Performs medical review of adverse events reported for investigational and marketed products Maintains familiarity with MedDRA, WHO-DRL, and safety databases such as ARGUS. Works closely with Safety and Pharmacovigilance (SPVG) colleagues to ensure appropriate medical interpretation and consistency are applied to adverse event case assessment Ensures regulatory and SOP compliance with respect to evaluation, reporting and surveillance of clinical and post-marketing safety information Identifies, communicates and effectively manages potential safety issues Interacts with client’s safety/medical personnel as appropriate Stays abreast of clinical and drug development information relevant to contracted programs Provides medical review and interpretation for aggregate safety reports (e.g. annual safety reports, PSURs, PADERs) Maintains medical and pharmacovigilance expertise through appropriate internal or external continued medical education Assists as a mentor and trainer for other internal safety staff including case processing staff Responsible for performing activities that are in compliance with applicable Corporate and D Departmental Policies, Standard Operating Procedures, Work Instructions and any project specific Operating Guidelines Performing other duties as assigned by management. Qualifications The incumbent should possess M.D., MBBS, D.O. Completed an accredited residency; Minimum of one to two (1 to 2) years of experience in clinical practice Minimum of one year of experience in the pharmaceutical, biotechnology, or device industry working in pharmacovigilance/epidemiology preferred Knowledge of global pharmacovigilance regulations and processes Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace), safety databases, and internet. Excellent verbal and written communication skills (proficient in English) as well as in the language required for case processing Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform and influence Ability to travel as necessary (up to 10%) Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Show more Show less

Roles and Responsibility Conduct thorough medical reviews of patient records, including diagnoses, treatments, and test results. Analyze medical information to identify trends, patterns, and areas for improvement. Collaborate with healthcare professionals to develop and implement effective treatment plans. Maintain accurate and up-to-date records of patient information and review findings. Participate in quality improvement initiatives to enhance the quality of medical care. Develop and maintain knowledge of medical terminology, regulations, and standards. Job Requirements Strong understanding of medical terminology, anatomy, and physiology. Excellent analytical, communication, and problem-solving skills. Ability to work effectively in a fast-paced environment with multiple priorities. Proficiency in using electronic health records systems and other healthcare software. Strong attention to detail and ability to maintain confidentiality. Ability to work collaboratively as part of a multidisciplinary team.

The key purpose of this role is to support Pharmacovigilance Operations PV Ops - ICSR Management in the following activities: ICSR Management Argus Configuration for new Programs/Studies ICSR processing Case Processing Coding Conventions Local Operating Companies (LOC) Interactions Functional Vendor Oversight: New Market Authorisation Withdrawal of Market Authorisation PAC awareness Clinical Trial/Program Interactions for: Study/Program Set up Study/ Program Maintenance Study/ Program Close out Argus Configuration for Submissions to destinations including Regulatory authorities Partners Clinical Research Organisations (CROs) LOCs Clinical Operations/CROs The position holder is responsible for the above elements in alignment with GSK standards and regulatory timelines whilst driving the implementation of robust processes for successful PV operations activities, including vendor oversight. Key Responsibilities Contribute to all aspects of case handling activities from case receipt to expedited reporting and collaborate with stakeholders (ie, the Safety Evaluation and Risk Management (SERM) group, local operating companies (LOCs) Application Development, Configuration and clinical operations/sciences) to ensure that documentation and processes are in place to achieve successful recording and reporting of safety data during the life cycle of a clinical trial and marketed product. Work across a complex matrix environment to drive high-quality delivery of case management activities that comply with internal standards and external regulatory requirements; where problems or issues are identified, facilitate investigation into root cause and create corrective/preventative actions (CAPAs) Escalate identified problems or issues to the appropriate Management Personnel with PV Operations Generate new ideas and proposals for global implementation; contribute to advancement of PV Operations methodology and processes. Ensures third parties/vendors develop and implement robust processes to support quality-driven organization. Demonstrate GSK values Supervise a team of up to 10 scientific staff (Global/ local) responsible for supporting ICSR Management activities. Manage team to ensure appropriate prioritisation and time management, in line with business needs Build external relationships with key stakeholders and senior leaders Provides project management and case processing oversight to ensures timely submission of expedite reports to Regulatory authorities, License Partners and CRO. Provides support and guidance to the ICSR Management Leads and team members to ensure compliance with global regulations and adherence to GSK SOPs Resolve issues and concerns within the ICSR Management team and escalate to ICSR Management Director, where resolution is not possible or there is impact across PV OPS Ensure that all ICSR Management activities are appropriately resourced and escalates any resourcing issues Provide workload forecasts and work with ICSR Management Director to strategically plan, in line with business goals Develop the team, identify training requirements and work with training team to establish required training plan for individuals as required Provide workload forecasts to PV Ops Directors and work with Director to strategically plan, in line with business goals Enhance matrix management across PV Ops, ensuring successful connections with PV Ops sub teams Education Requirements Degree in life sciences or medically related field or previous experience equating to educational requirements. Job Related Experience Knowledge of GSK products and business structure Project management experience Ability to map processes and author written standards Knowledge and experience with pharmacovigilance systems knowledge of GCP and GVP requirements and reporting of adverse events with a general understanding of world-wide requirements for PV Technical understanding of safety processes including regulatory interpretation, SOP/GUIs, Systems/data base conventions Direct experience working with outsourced providers

Job OverviewaApply knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents. Essential Functions Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements (SLA). Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required. Conduct/Lead ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review. Act as Signal Management Lead on post-marketing and clinical trial projects. Set-up, implement, organize (including documentation) and lead safety management teams. Set-up and update products' signaling strategies. Author and/or QC review all types of signal management deliverables. Lead/ conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks . Responsible for full documentation and tracking of signals. In a PV support role, lead/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents. Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory affairs Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed. Participate in internal and external audits and inspections, as required. Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics. Read, acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Serve as the interface between the global project lead and the working team conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members. Provide mentorship and training to less experienced resources. Provide regular reports to overall project manager and department management on project metrics, SOW changes, client requests or concerns participate in project review meetings with management communicate and document project issues to project team members and department management in a timely manner. Ensure Good Documentation Practices (GDP). Support and/or contribute to technology / innovation activities. Qualifications Bachelor's Degree In a Scientific or Healthcare discipline Req 2 - 3 years relevant work experience. Pref Equivalent combination of education, training and experience. Req Excellent knowledge of Lifecycle Safety services and processes. Intermediate willingness and aptitude to learn new skills across Lifecycle Safety service lines. Advanced In depth knowledge and understanding of applicable global, regional, local regulatory requirements. Intermediate i.e. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and International Conference of Harmonization (ICH) guidelines, SOPs. Intermediate Proven ability to meet strict deadlines. Advanced manage competing priorities and ability to be flexible and receptive to changing demands. Intermediate Excellent organizational skills and time management skills. Intermediate Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint). Intermediate Good knowledge of medical terminology. Intermediate Proven ability to follow instructions/guidelines, work independently and on own initiative. Intermediate Excellent attention to detail and accuracy maintaining consistently high quality standards. Advanced Excellent written/verbal communication and report writing skills. Intermediate Sound judgment. Intermediate independent thinking and decision making skills. Intermediate Self-motivated and flexible. Advanced Ability to establish and maintain effective working relationships with coworkers, managers and clients. Intermediate Effective mentoring and coaching skills. Intermediate Good understanding of operational metrics, productivity and initiatives. Intermediate Demonstrate effective project management and leadership skills. Intermediate IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com Show more Show less

Clinical Operations Manager POSITION PURPOSE The COM 2 is a regional role that provides expertise across a ll aspects of clinical site management and/ or study management for assigned Phase I - IV studies. The COM 2 operates in line with Good Clinical Practices (ICH-GCP), applicable regulatory and legal requirements and Bayer s standard operating procedures. The COM 2 may be assigned work packages in areas of study start-up, site management and study management on a regional level. Either one or a combination of these work packages may be allocated to the position holder according to expertise, skill set and capacity requirements in a flexible way. The COM 2 must acquire knowledge and adequate training for work packages assigned and become proficient in independently executing assigned responsibilities. A work package is any combination of the individual responsibilities listed below. Work packages are not fixed, can be allocated per study, and distributed within the team. Allocation and distribution of responsibilities must adhere to Bayer s standard operating procedures, including any requirements for independent review and oversight. ROLE AND RESPONSIBILITIES STUDY MANAGEMENT Lead and oversee all operational aspects of site management on a regional or study level from protocol feasibility to study archive. Serve as the representative for site management on the core study team. Contribute to the development of the protocol, study overview, monitoring strategy and Risk Based Quality Management with regards to monitoring and operational aspects. Responsible and accountable for developing the monitoring plan and the study-specific training plan. Key contributor in the development of recruitment and retention strategies and tools. Act as key study contact for assigned countries. Responsible for overall deliverables regarding timelines, budget, and quality in assigned countries. Ensure participating country commitment aligns with study commitments. Provide the information required to effectively monitor and manage study activities, ensuring all relevant IT systems are updated with precise and current data. Oversee monitoring activities and ensure sponsor oversight through monitoring report review and co-monitoring visits. SITE MANAGEMENT Act as primary contact for investigational sites. Verify site qualification, ensure the Investigator, and site staff meet all aspects of study delivery and commitments from site selection through close out. Train the Investigator and site staff on study protocol, relevant systems and operational aspects of study conduct. Monitor trial conduct in compliance with the study protocol, ICH-GCP and applicable regulatory requirements on time and quality. Ensure completeness of the Investigator Site File. Prepare and conduct onsite and/or remote monitoring activities according to monitoring plan, including complete reporting and follow up. CLINICAL CUSTOMER ENGAGEMENT Cultivate and sustain customer relations with clinical trial sites, ensure effective communication, drive fit for purpose processes and work towards enhancing overall site satisfaction and engagement. Establish and develop strong professional relationships with clinical investigators to expand/ maintain clinical research partnership opportunities. Cross functional collaboration to ensure alignment of priorities and deliver the portfolio. Influence and challenge internal and external factors to improve clinical research delivery. STUDY START-UP Lead study start-up activities in collaboration with local team. Provide input on site activation strategy. Collect and perform quality review of essential documents on country level such as IRB/IEC approvals, financial disclosure, CVs/medical licenses, etc. Compile and submit submission dossier (country dependent). Obtain any required approvals for relevant site documents (e.g., informed consent, financial disclosures). Prepare and distribute site start up documentation including Investigator Site File. Ensure timely filing of study documents at country and site level in Trial Master File (TMF). Ensure awareness of related local regulations and support maintenance of country intelligence. Provide study status monitoring and systems support (e.g. act as technical expert) Coordinate site and vendor payments. QUALITY Proactively identify and communicate issues, taking appropriate action to prevent the recurrence of identified deviations. Ensure timely and comprehensive resolution of issues that may affectcompliance or the quality of study related activities or data. Maintain corrective action and preventative action plans (CAPAs) at country level. Contribute to the preparation, conduct, and follow-up of Site Audits and Regulatory Inspections to ensure a successful outcome. Oversee completeness of country/site level eTMF and conduct QC for accuracy, completeness, and adherence to ICH/GCP and Bayer QSDs. OTHER Participate in expert working groups, project standard teams, and similar initatives. Contribute to global process improvement efforts. Share knowledge and experience with a coaching mindset Maintain therapeutic and technical expertise to enable discussions with investigators and site personnel. KEY WORKING RELATIONS: Internal: Locally and regionally with other COM 2s, medical affairs, pharmacovigilance, regulatory affairs, legal and other functions. Globally with study team members, QA & Inspection management. External: With site personnel, third party vendors, health authorities, IRB/EC, and inspectors, thought leaders including steering committee members, national leaders and/or other committees. WHO YOU ARE: Healthcare related Bachelor s Degree or equivalent with minimum 4 years of monitoring and site management experience. Or have a combination of education and minimum 8 years of monitoring and site management experience. Other qualifications: Fundamental project management skills Awareness & understanding of cultural and regional differences Communication, oral presentation & interpersonal skills Decision making Issue resolution Planning and organization, time management, prioritization Thrives in ambiguous and collaborative environments and embraces change Effective written and verbal English communication skills Willingness to travel to sites, study meetings, local and international level Ever feel burnt out by bureaucracy? Us too. That s why we re changing the way we work for higher productivity, faster innovation, and better results. We call it Dynamic Shared Ownership (DSO). Learn more about what DSO will mean for you in your new role here Bayer does not charge any fees whatsoever for recruitment process. Please do not entertain such demand for payment by any individuals / entities in connection with recruitment with any Bayer Group entity(ies) worldwide under any pretext. Please don t rely upon any unsolicited email from email addresses not ending with domain name bayer.com or job advertisements referring you to an email address that does not end with bayer.com . Location: India : Karnataka : Bangalore || India : Maharashtra : Thane Division: Pharmaceuticals Reference Code: 848115 Contact Us + 022-25311234