1172 Pharmacovigilance Jobs - Page 6

Title Due to our continued growth, we are in need of qualified and focused individuals, like yourself. This is a vital role with our Clinical Safety team whose success relies upon your finely tuned skills and background. If you are ready to make a difference, you must be able to accomplish these tasks: Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Implementation of routine system configuration including product, study and license in Argus and Argus J; Assist with creating reports using Oracle Business Intelligence reporting tool; Resolve safety database-related issues; Prepare/Execute User Acceptance Testing (UAT) of safety system changes; Assist in Argus Database Training for new users, as applicable; Generate outputs from the global safety system in support of periodic safety reports (e.g. DSUR, PSUR and PBRER) ; Assist in the development of system support related process, SOPs, Work Instructions and manuals and Support Inspection and Audits. Qualifications Bachelor’s Degree in scientific discipline or Business Informatics or similar area with 1-2 years of directly related experience; Preferred Qualifications: Work experience in CRO/biotech/pharmaceutical industry. Experience in Study configurations in Safety Systems. Experience with Safety Database preferably Argus and Argus J. Experience in SQL. Experience in reporting and analytic platforms such as OBIEE. Strong client service orientation. Strong consultative problem-solving skills. Ability to combine technical problem-solving skills with discernment to resolve best business solution. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Title Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Clinical Data Coder to join our Clinical Coding & Support team in Mumbai, India. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous coding, pharmacy, or nursing expertise and can develop and grow your career even further, then this is the opportunity for you! Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Perform accurate coding of medical terms and medications utilizing industry-wide standards as well as company standards; Coordinate the assignment of appropriate dictionaries for meeting study requirements; and Develop and maintain coding guidelines Qualifications Bachelor Degree in Nursing, or more advanced clinical degree; Experience with using MedDRA and WHO Drug dictionaries; and Experience working with clinical trials or within the pharmaceutical environment is preferred. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Title We are currently seeking an full time office based Experienced Study Start up Submissions Coordinator to join our Clinical Operations team in India Mumbai. This role is a vital part of the team to accomplish tasks and projects that are instrumental to the company’s success. If you are interested in an exciting career where you can use your expertise and develop and grow your career even further, then this is the opportunity for you. Our culture is of expertise, and we empower our teams to employ their unique talents and experience to take an assertive approach to research, problem solving, and ultimately supporting our business partners. At Medpace, our employees embody our values and our approach to serving our clients. They work hard, understand our high expectations, and rise to the challenge. In return they are rewarded with interesting projects, career advancement, and recognition and exposure to our international footprint. These are just a few reasons why talented individuals join the Medpace team. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Perform required activities within the country that lead to activation of investigative sites in all phases of clinical trials; Prepare, review, and submit to Regulatory Agencies; Communicate with global study teams and personnel on study progress; Ability to effectively identify risks to site activations and mitigate as necessary; Provide expertise and guidance to global study teams in ethics and regulatory submissions; Review and finalize essential documents required for site activation; Act as a main contact for Ethical and Regulatory submission-related activities; Direct contact with investigative sites during the study start up and activation process; Ensure submissions comply with applicable regulations and guidance documents; Advise sponsors on changing regulations and compliance requirements; and Track submissions and ensure timely filing of documents. Qualifications Bachelor's degree in the science field or equivalent combination of education and experience; At least 4 years of relevant working experience at a CRO, Pharmaceutical Company, or an investigative site; Excellent organization and communication skills; Knowledge of Microsoft® Office, ICH - GCP guidelines and regulatory guidelines; Hands-on experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies; including formulating responses to queries; and Good command in English. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Title Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based IRT Validator to join our Randomization and Study Product Management team in Mumbai, India. This position plays a key role in the clinical trial management process at Medpace. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Creation of test plans; Execution of test plans and creation of validation packages; Review of validation packages created by other team members; Review requirement specification documents provided by internal clients; Validation of new projects and changes to existing projects; Qualifications Bachelor’s degree in Math, Computer Science, or related field required; Demonstrated ability to complete validation tasks within defined time frames and to appropriate quality levels; Fluent in English. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Title Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Data Review Associate in Mumbai, India to join our Global Clinical Coding & Support team. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous nursing expertise and can develop and grow your career even further, then this is the opportunity for you! Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Comprehensive manual review of clinical data collected in trials Development of clinical review guidelines for specific therapeutic areas Interface with Data Management team to assure query resolution Seeking specialization in following therapeutic areas: Oncology Hematology Infectious Disease Endocrinology Metabolic disorders Qualifications Bachelor’s Degree in Nursing / Medicine, or more advanced clinical degree Professional / or Post-Qualification Nursing experience, preferably in Oncology and Hematology background General knowledge of clinical trial processes and/or experience working with clinical data Experience with using MedDRA and WHO Drug dictionaries will be a plus. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Title Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based SAS Programmer to join our Biostatistics team in India, Mumbai. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Write SAS programs for use in creating analysis datasets, tables, listings, and figures Using SAS, program, validate and maintain mapped database Program edit checks for external data Coordinate communication and issues with Data Management regarding database specifications and data transfers Qualifications Bachelor / Master’s Degree in math, Statistics, health informatics, data science, computer science, or life sciences field SAS Ceritifcation SAS knowledge required and 1 to 2 years' experience is preferred Good English written/communication skills is required People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Title We are currently seeking a full-time, office-based Study Start up Submissions Coordinator to join our Clinical Operations team in Mumbai, India office. This role is a vital part of the team to accomplish tasks and projects that are instrumental to the company’s success. If you are interested in an exciting career where you can use your expertise and develop and grow your career even further, then this is the opportunity for you. Our culture is of expertise, and we empower our teams to employ their unique talents and experience to take an assertive approach to research, problem solving, and ultimately supporting our business partners. At Medpace, our employees embody our values and our approach to serving our clients. They work hard, understand our high expectations, and rise to the challenge. In return they are rewarded with interesting projects, career advancement, and recognition and exposure to our international footprint. These are just a few reasons why talented individuals join the Medpace team. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Perform required activities within the country that lead to activation of investigative sites in all phases of clinical trials; Prepare, review, and submit to Regulatory Agencies; Communicate with global study teams and personnel on study progress; Ability to effectively identify risks to site activations and mitigate as necessary; Provide expertise and guidance to global study teams in ethics and regulatory submissions; Review and finalize essential documents required for site activation; Act as a main contact for Ethical and Regulatory submission-related activities; Direct contact with investigative sites during the study start up and activation process; Ensure submissions comply with applicable regulations and guidance documents; Advise sponsors on changing regulations and compliance requirements; and Track submissions and ensure timely filing of documents. Qualifications Bachelor's degree in the science field or equivalent combination of education and experience; At least one year of relevant working experience at a CRO, Pharmaceutical Company, or an investigative site; Excellent organization and communication skills; Knowledge of Microsoft® Office, ICH - GCP guidelines and regulatory guidelines; Hands-on experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies; including formulating responses to queries; and Good command in English. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Roles and Responsibilities Provide clinical pharmacology services, including drug therapy monitoring, adverse event reporting, and medication management. Conduct research studies related to clinical pharmacology and pharmacovigilance. Develop and implement educational programs for healthcare professionals on clinical pharmacology principles. Collaborate with multidisciplinary teams to ensure effective patient care. Stay up-to-date with latest developments in clinical pharmacology through continuous learning.

In this role you will be responsible for: The coder reads the documentation to understand the patient's diagnoses assigned - Transforming of healthcare diagnosis, procedures, medical services, and equipment into universal medical alphanumeric codes - Creating uniform vocabulary for describing the causes of injury, illness & death is the role of medical coders - Medical coding allows for Uniform documentation between medical facilities - The main task of a medical coders is to review clinical statements and assign standard codes of the role include: - 0 -1 Year of experience in any Healthcare BPO - University degree or equivalent that required 3+ years of formal studies in Life science/BPT/Pharm/Nursing - Good knowledge in human Anatomy/Physiology - 1+ year(s) of experience using a computer with Windows PC applications that required you to use a keyboard, navigate screens, and learn new software tools - Ability to work scheduled shifts from Monday-Friday 7:30 AM to 5:30 PM IST and the shift timings can be changed as per client requirements. Flexibility to accommodate overtime and work on weekend"™s basis business requirement. Ability to communicate (oral/written) effectively in English to exchange information with our client. Must be a CPC-A Certified and working from office mandatory

In this Role you will be Responsible For The coder reads the documentation to understand the patient's diagnoses assigned Transforming of healthcare diagnosis, procedures, medical services, and equipment into universal medical alphanumeric codes Creating uniform vocabulary for describing the causes of injury, illness & death is the role of medical coders Medical coding allows for Uniform documentation between medical facilities The main task of a medical coders is to review clinical statements and assign standard Codes of the role include 3+ Year of experience in any Healthcare BPO _ ED PROFEE & FACILITY / CPC CERTIFIED Highlights documentation deficiency / Play SME role for freshers Good knowledge in EM outpatient coding and multispecialty + Procedure codes 1+ year(s) of experience using a computer with Windows PC applications that required you to use a keyboard, navigate screens, and learn new software tools Ability to work scheduled shifts from Monday-Friday 7:30 AM to 5:30 PM IST and the shift timings can be changed as per client requirements. Flexibility to accommodate overtime and work on weekend"™s basis business requirement. Ability to communicate (oral/written) effectively in English to exchange information with our client

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Min 5 yrs of experience in Data Acquisition domain. Expertise in Handling Non-CRF activities, able to work autonomously on the non-CRF data strategy. In-depth understanding of Data Management conventions, data standards, Processes and Drug development Process. Experience with Study convention including non-CRF collection data standards, Processes, Knowledge sharing and best practices on assigned studies. Influence Study Team to adhere non-CRF guidance, processes and negotiate contingency plans to mitigate delays of deliverables.

Job Description As a Therapy Business Manager you will be responsible for developing and implementing all sales strategies in the assigned market. Further you will drive primary and secondary sales, ensure brand presence in the assigned market and manage the distributor network to achieve desired sales/business objectives. Roles and Responsibilities in detail Business Generation & Development Achieve monthly, quarterly, half yearly and yearly sales target by promoting company’s product ethically to customers as per the business plan Having science-based discussion with doctors and chemists for promotion of product in clinic and at chemist place Organizing Camps (CME) as per the division strategy and customer needs To plan and conduct merchandising and sampling activity as per Division strategy. Facilitate the process of successful new product / products launch in the territory by undertaking correct identification and targeting customers for the new product, meet them at pre-determined intervals, effective in clinic / trade promotion and share feedback with the company Execute the customer management plan to ensure that all the customers are covered as per the plan and meet minimum KPIs as follows: a. 100% coverage of Doctors. b. Customer Call average as per the customer management plan of the division / therapy. c. Market intelligence collection, retailer level inventory management calls as per the product profile and marketing strategy of the therapy / division. Prescription audit for Abbott brands and other competitors’ brands To create and update customer list having specified number of doctors / chemist (Trade) as per the therapy / product requirement and maintain the same in physical / electronic format. Identifying potential town and appointing distributor and customers (trade) in line with business philosophy Brand Management Ensuring the visibility of Abbott brands on retailers’ outlet as a part of brand promotion strategy To carry out activities across trade and clinics for brand visibility To plan and attend Retail meets, Market Blitz etc. for sales growth Generate POBs for Abbott brands as per the business plan Recommend appointment of a party as a distributor after evaluating its commercial standing, credit worthiness and personal assets. Ensure that stock and sales statements have been sent by the distributors on due dates Ensure that the claims of the distributors are settled by company within specified time limits Responsibilities You are manager of the company in your territory and will be authorized to build company’s reputation in your territory. You will be responsible for practicing and leading other junior team members of the company by setting personal example of excellence in: 1. Lead and execute strict adherence to Abbott Code of Business conduct 2. Set examples on implementation of the code of business conduct, FCPA , Pharmacovigilance to ensure compliance 3. Conformation to all financial and administration systems, compliance to statutory and regulatory norms of the company and laws of the land 4. Demonstrate and promote professional behavior in line with Abbott Values of Pioneering, Achieving, Caring and Enduring 5. Ensure high level of customer service and manage any difficult customer situations. 6. Ensure compliance with internal and external guidelines and ensure minimal comments in audits and other inspections 7. Ensure transactions and orders are processed with a high level of accuracy and commitment in order to satisfy customer needs 8. Manage attrition of customer and resource bases 9. Division and business strategy will be shared with you on time to time base which you will have to execute to the fullest 10. To attend and participate in Strategy meetings, briefing sessions, doctors meets, workshops, training programmes and any other programmes undertaken by the company to equip you or activities for performance of your job or promote the sales of product of the company or to improve company image. 11. Ensure adherence to EHS policies, procedures, rules and regulations. Attend all required EHS trainings as applicable. Wear safety gears (e.g. Helmet) while riding on two-wheeler. Report any EHS incidents and/or near misses (unsafe acts and conditions) promptly to supervision. Forward any opportunities to improve the EHS program to supervision. Authorized Signatory Show more Show less

Additional Locations India-Chandigarh; Job ID R0000031635 Category Medical Sciences ABOUT THIS ROLE Key Accountabilities : Technology Support Under supervision, conduct set-up and support activities associated with the Parexel safety database (and associated systems) including but not limited to new study set-up - Periodic report configuration and generation with oracle Analytics. Ad-hoc report configuration and generation with oracle Analytics. Expedited report rule configuration with oracle Analytics. End-user support. Provide support in the planning and delivery of the handover of the safety database from client to Parexel were contracted to take over the pharmacovigilance tasks for client projects. Provide support in the planning and delivery of the handover of safety data from Parexel to client at the end of study/project as contracted. Adhere to standard operating procedures and controlled documents that pertain to safety technology. Organizational Representation Interface with other Parexel groups (such as TQM, QA, IT) to ensure that database, hardware, network, security, quality, integration, support and project services associated with maintained systems are adequate and sufficiently managed. Support colleagues when working with external auditors and inspectors during the examination of safety technology. Issue Management Under supervision, collaborate with Parexel IT, vendor, Parexel Safety Services staff, and clients for the proper analysis, resolution, and closure of issues for supported systems. Team Support Provide support to new staff in the systems and activities necessary for the fulfillment of their job responsibilities. Change Management Under supervision, support change management in accordance with the Software Development Life Cycle. Under supervision, support execution of tasks for software updates, change requests and application support for the supported applications. Under supervision, support the implementation of technology solutions for Safety Services for the purposes of business process optimization and improvement. Ensure adherence to regulations concerning computer system validation, 21 CFR Part 11 compliance, procedures, and quality standards. Skills: Good interpersonal, verbal, and written communication skills. Client focused approach to work. Good analytical and problem-solving skills. Good organizational and customer service skills. Willingness to work in a matrix environment and to value the importance of teamwork. Provide support to a team working through problem management. Under supervision, take ownership of core tasks related to the support and maintenance of safety technologies. Basic System Administration and application support skills within pharmacovigilance. safety technology, including at least one of: safety databases, gateway / E2B, report development, signal detection. Basic skills in using standard scripting languages e.g., SQL. Knowledge of industry standard Service Desk Tools. Basic technical writing capability. Knowledge of standard SDLC processes including change management. Knowledge of Agile methodology. A flexible attitude with respect to work assignments and new learning. Under supervision, complete multiple and varied tasks with enthusiasm and prioritize workload. Knowledge of system validation and change management. Basic knowledge of computer system regulations and guidance in the pharmaceutical industry including: 21 CFR Part 11, EMA Annex 11, GAMP. Basic knowledge of Pharmacovigilance roles, standards and practices. Basic knowledge of GVP and GCP. Education: Bachelor’s degree in engineering/computer science, master's or equivalent preferred.

Senior Auditor, Quality Assurance- Hybrid 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 Senior Auditor Quality Assurance to join our diverse and dynamic team. As a Senior Auditor Quality Assurance at ICON, you will play a pivotal role in ensuring the quality and compliance of clinical trials, interpreting regulatory requirements, and contributing to the advancement of in Native treatments and therapies. Job Location: Bangalore (Remote Based) Responsibilities and Qualifications: Manage complex Quality Issues to include supporting Root Cause Analysis, Impact Assessment and appropriate Corrective Action and Preventive Action (CAPA) Plans. Respond to audit findings and support audit responses to assess compliance with corporate policies, industry standards, and applicable regulations. Lead/Support regulatory Inspection hosting Lead/Support Sponsor Audit Hosting Independently conducts the following activities as assigned by Quality & Compliance (Q&C) management Manage Quality Issues Lead Quality Issue Investigations Supports Operations in Root Cause Analysis and CAPA Plan preparation. Support Effectiveness Check development and outcomes. Assist with the implementation and maintenance of an effective Quality Management System/ Quality Assurance program within the relevant Quality & Compliance (Q&C) team. Perform departmental and ICON staff training regarding ICON’s quality system, Q&C tasks and processes, applicable standards, and regulations. Mentor new or developing Q&C staff as assigned. Support business development activities and Q&C initiatives as needed. Host regulatory inspections of the site/ICON/Sponsor as Lead Host or Co-host Host Sponsor audit ICON as Lead Host or Co-host What you will have: 5 years’ experience working in a clinical, regulatory, pharmacovigilance, or quality environment within CRO/ pharmaceutical / healthcare industry. Advanced knowledge of GCP (Good Clinical Practice) Excellent organizational skills. Must possess a technical knowledge that is applicable to clinical drug development. An undergraduate degree, its international equivalent in the sciences, technology, auditing, etc. from an accredited institution or sufficient previous experience in auditing is required Excellent knowledge of MS Office (including Microsoft Word, PowerPoint and Excel). Critical thinker that sees the "big picture" (e.g. overall themes, trends, goals), generates innovative ideas and solutions to problems and makes recommendations in the face of complexity, conflicting pressures and ambiguous circumstances. Professional communicator, able to gain and maintain a trusted relationship while delivering difficult messages Team worker, able to listen to others but also influence in order to see the wider picture and achieve a vision Read, write and speak fluent English. What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Performing triage and review for initial validity assessment of cases including spontaneous, health authority, Clinical Trial and literature cases. Data entry into PV database Initial ICSR assessment, if applicable Evaluation of the need for expedited reporting to Health Authorities / partners of a client concerned, including reporting timelines Preparation of standard reporting forms (e.g., CIOMS I / MedWatch Forms and XML files) Preparation and sending of follow‐up requests Submission of ICSRs to Health Authorities and partners of a client Case completion / documentation Conduct quality checks of Individual Case Safety Reports (ICSRs) and ensure quality assurance in accordance with project requirements, maintaining compliance with industry standards and best practices to enhance the integrity and reliability of safety data. The ICSR search/retrieval process from the EVWEB database and company/non-company assessment for cases. Allocation and cases workload management Providing training of the system to the respective team members. Actively mentor and support new joiners by providing guidance on company processes, facilitating their integration into the team, and fostering a collaborative learning environment to enhance their professional development. Responsibilities will be assigned by the supervisor in accordance with process requirements. . The ICSR search/retrieval process from the EVWEB database and company/non-company assessment for cases. Allocation and cases workload management Providing training of the system to the respective team members. Actively mentor and support new joiners by providing guidance on company processes, facilitating their integration into the team, and fostering a collaborative learning environment to enhance their professional development. Responsibilities will be assigned by the supervisor in accordance with process requirements. What Cencora offers Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements. Full time Affiliated Companies Affiliated Companies: PharmaLex India Private Limited Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

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 Safety Scientist to join our diverse and dynamic team. As a Safety Scientist at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of inNvative treatments and therapies. What You Will Be Doing Conducting safety surveillance activities for assigned projects, including the review and interpretation of safety data. Partnership with cross-functional teams to ensure the safety of study participants and compliance with regulatory requirements. Contributing to the development and implementation of safety management plans and risk minimization strategies. Participating in safety review meetings and providing expert input on safety-related matters. Contributing to the preparation of safety-related documents for regulatory submissions and responses to regulatory queries. Oversees operational activities as the functional PV team lead. Assist project teams in client meetings when pharmacovigilance, safety surveillance, risk management which require expert knowledge beyond the expertise of Drug Safety Associates are discussed Support literature search and review projects by: Authoring literature search and review plans for routine pharmacovigilance, local literature, aggregate safety analysis, EMA Medical Literature Monitoring Defining search parameters (string terms) Conducting literature search and review as per project-specific plan Under the Guidance of a Director, Pharmacovigilance specialized services and/or Senior Principal/ Principal safety scientist, the safety scientist is responsible for: Aggregate safety report generation Coordinate aggregate safety report generation, including data collection, data and document querying, coordination of internal and external reviews, and interfacing with the Client and Safety Writers. Generate and maintain aggregate safety report plans including generation of data specifications and literature search requirements. Author where necessary or review aggregate safety report drafts, including Sponsor authored drafts where ICON is legal representative Safety surveillance activities Coordinate and document the signal detection strategy Draft required plans and forms Manage and organize the source data Participate in development and generation of the data assessment visuals and tables in ICON visualization tool. Review interval and cumulative data as per safety surveillance plan Document and track all signal management activities Generate and / or Review signal detection reports, signal validation reports and signal assessment reports Organizes and coordinates internal and external meetings regarding signal management, including drafting of minutes Draft safety section of product reference documents (e.g. IB/ reference safety information, CCDS/CCSI, local labeling). Review of safety sections of a protocol, Review safety listings, review of ICSRs Generation of development risk management plans (dRMP), risk management plans (RMP), and risk evaluation and mitigation strategies (REMS) Coordinate risk management document generation, including data collection, data and document querying, coordination of internal and external reviews, and interfacing with the Client and Safety Writers. Track initial RMP filing and subsequent updates Support risk management SMEs on appropriate strategy and design of risk management activities and risk minimization measures. Perform implementation, tracking and communication of risk management commitments including risk minimization measures Contribute to generation and maintenance of: Pharmacovigilance system master files (PSMF) and associated project plans. Pharmacovigilance agreements and associated project plans Other activities: Assist with the maintenance of key performance indicators (KPIs) and compliance metrics. Assist in preparation of audits and inspections. Participate in ICON initiatives for the implementation and integration of new or enhanced: Process development or maintenance (SOPs, WPs, templates, best practices) Systems, databases and tools Development and/or delivery of training courses on pharmacovigilance related topics to ICON Your profile Bachelor's degree in life sciences, pharmacy, or related field; advanced degree preferred. Solid experience in pharmacovigilance or drug safety within the pharmaceutical or clinical research industry. Strong understanding of pharmacovigilance principles, regulations, and guidelines. Excellent analytical and critical thinking skills, with the ability to interpret complex medical data. Effective communication skills, with the ability to cooperate effectively with cross-functional teams. Detail-oriented and able to work effectively in a fast-paced environment with changing priorities. 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

Skill required: Clinical Data Services - Clinical EDC Build Designation: Clinical Data Svs Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 3 to 5 years Language - Ability: English(International) - Expert About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects. You will be expected to develop clinical study databases by building electronic case report forms and program edit checks as per specifications. Support any updates or changes to the study database (e.g. Protocol amendments) through the change control process. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship Roles and Responsibilities: Clinical Database Developers: Overall experience of 4+ years with exposure to EDC platforms like Medidata RAVE EDC, Inform, Oracle Clinical, Veeva etc. preferred. Extensive experience in database design, edit check programming, custom function programming and unit testing. Experienced in various modules such as IVRS/RWS integration and Lab administration. Medidata RAVE study builder certified preferred. Show more Show less

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. Essential Functions Provide statistical programming and validation for life sciences-related projects including clinical trial datasets and tables, listings, and figures. Access and convert data to SAS datasets and other file types from database management system and PC file formats (e.g., Microsoft Excel, text files). Work with external vendors to develop and/or monitor the content and structure of SAS datasets and other files. Work closely with statisticians and other statistical programmers to generate and validate outputs to ensure accuracy and ensure the quality and soundness of statistical programming algorithms. Provide input to specifications of tabulation and analysis datasets, validation plans, and other related documents Other duties as assigned. Necessary Skills And Abilities In-depth knowledge of statistical programming. Excellent communication and interpersonal skills, with the ability to work collaboratively in cross functional teams and with external partners. Ability to program in SAS and/or R preferred. Educational Requirements Bachelor’s degree in Statistics, Computer Science, Mathematics, or a related discipline, or a combination of other education with 1+ years of relevant work experience. Experience Requirements Experience with CDISC data structures, such as SDTM and ADaM. We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.*** Show more Show less

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

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: BSc/Bachelor of Pharmacy Years of Experience: 0 to 1 years Language - Ability: English(International) - Proficient About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases. Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for? Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines. Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Show more Show less

Skill required: Pharmacovigilance Services - Safety Writing Designation: Pharmacovigilance Services Specialist Qualifications: Bachelor of Pharmacy Years of Experience: 7 to 11 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? Prepare and review PSUR/ PBRER/DSUR/PADER/ Addendum Statement/Addendum to clinical overview/US IND reports/ Aggregate finding safety reports/Local reports/ Cumulative Review/Health Authority requests / Health Authority assessment reports as per the applicable procedural documents on the project. Perform scheduling of reports, and author, peer review, publishing, tracking and management activities of assigned reports. Perform request for inputs activity for the reports (based on the RFI [request for information] and as per the applicable process and SOPs). Send the case closure request and request for Line Listings/Summary Tabulations, as applicable. Initiate, organize, and lead the strategy meeting for evaluation of safety topic/request. Prepare meeting minutes and distribute final minutes with all invitees. Review the information received from contributors and obtain any missing information. Draft aggregate report using clients’ templates including analysis of safety, clinical and other global line function data. Summarize literature information for applicable reports. Perform peer review of the draft report. Share the draft for quality review. Address the comments from the peer reviewer, quality reviewer and incorporated into the report. Share the draft report with client (or external) stakeholders for review (as applicable). Incorporate and address the comments from stakeholders into the draft report and seek clarification where applicable. Schedule meetings with project safety physicians to resolve report related queries and prepare submission ready draft report. Perform final peer review of draft reports and provide feedback with the duly filled defect tracker. Share the final draft along with the QC scorecard results to client (as applicable). Obtain Client/ESP signature/approvals for the finalized report. Complete and finalize report according to the procedural document requirements. Ensure compliance of finalized report with applicable process and SOPs. Obtain signature/approval for the finalized reports as defined in procedural document What are we looking for? Ability to establish strong client relationship Roles and Responsibilities: Prepare/compile the final report and confirm that document is complete, including it contains all the applicable annexes as needed and instructed by client, and then submit the finalized report to client. Notify client (regulatory team) that the final report has been submitted to client and confirm all prepared submission documents are uploaded into client environment. Archive AR-related information in dedicated folders on client shared drives or other electronic repositories (as agreed in the procedural document). Perform HA submission tracking of applicable Aggregate Reports Capture quality data for metrics reporting. Responsible for knowledge sharing, coaching, review and providing feedback of reports processed by the Mentees. Complete all trainings assigned by internal and client on their LMS within due date. Notify critical and major deviations (referred as Quality Issues) within one business days and minor deviations- three business days to Accenture Quality Management team. Organize, action, and archive the communication received at and sent from AR mailbox appropriately. Share/forward product/document type relevant emails to the appropriate user/owner as required and ensure closure. Management of Accenture personal assigned to the AR function. Oversight on the AR mailbox management Ensure team’s delivery of reports within agreed timelines with SLAs and KPIs. Liaising with client or any issue mitigation and troubleshooting. Ensure the retention. Ensure training and mentoring of new associates and documentation of the same. Address any quality related issues and implementation of quality improvement initiatives for the team. Show more Show less

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: BSc/Bachelor of Pharmacy Years of Experience: 0 to 1 years Language - Ability: English(International) - Proficient About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases. Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for? Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines. Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Show more Show less

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: BSc/Bachelor of Pharmacy Years of Experience: 0 to 1 years Language - Ability: English(International) - Proficient About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases. Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for? Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines. Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Show more Show less

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Established in 1806 as a small soap and candle business in New York City, Colgate-Palmolive is now a truly global company with products sold in over 200 countries and territories under such internationally recognized brand names as Colgate, Palmolive, Softsoap, Irish Spring, Protex, Sorriso, Kolynos, elmex, Tom's of Maine, Sanex, Ajax, Axion, Soupline, Haci Sakir, Suavitel, PCA SKIN, EltaMD, Filorga and Hello as well as Hill's Science Diet and Hill's Prescription Diet. Colgate-Palmolive is a leading consumer products company that serves hundreds of millions of consumers worldwide with brands and products across four core businesses – Oral Care, Personal Care, Home Care and Pet Nutrition. We are committed to offering products that make lives healthier and more enjoyable, and programs that enrich communities around the world. Every day millions of people trust our products to care for themselves and the ones they love. Our goal is to use our technology to create products that will continue to improve the quality of life for our consumers wherever they live. A career at Colgate-Palmolive is an excellent opportunity if you seek a global experience, constant challenge, and development opportunities in an environment that respects work/life effectiveness. Job Title: Research Trainee - GS&S Travel Required?: No Travel Date: Jun 10, 2025 No Relocation Assistance Offered Job Number #167436 - Mumbai, Maharashtra, India Who We Are Colgate-Palmolive Company is a global consumer products company operating in over 200 countries specializing in Oral Care, Personal Care, Home Care, Skin Care, and Pet Nutrition. Our products are trusted in more households than any other brand in the world, making us a household name! Join Colgate-Palmolive, a caring, innovative growth company reimagining a healthier future for people, their pets, and our planet. Guided by our core values—Caring, Inclusive, and Courageous—we foster a culture that inspires our people to achieve common goals. Together, let's build a brighter, healthier future for all. What are we looking for: We are looking for smart, dynamic candidates to join us as trainees who will work in our India Global technology center (GTC) based in Mumbai. It will be a learning & growth opportunity for them to learn about many aspects of Product Lifecycle Management. We are the guardians of Colgate’s Proprietary data in the form of its raw materials and recipes. Data governance of master data of Colgate raw materials and recipes is our primary responsibility. All activity related to assigning correct master data to raw materials and recipes post proper review, assigning access after due diligence of each user’s background and supporting allied functions of the group like PDM data Cleansing and System testing would be a part of the regular activities. Along with this administrative role, every Scientist in India GTech is expected to be an integral part of EHS & Quality standards that ensures Safety & Quality of our products and working environment. This team works on strong partnerships with cross categories within India GTech & other GTechs & plants. The tenure for a trainee is proposed to 2 years from the date of joining. What you’ll need Post graduate in Pure sciences (Chemistry ,Biology)/ Pharmacy/ Technology (Cosmetics) with strong fundamental knowledge in basic chemistry and fair to good exposure to SAP database management / system administration activities and concepts Working knowledge of Microsoft Office or Google Suite proficiency (i.e, Sheets, Slides, Docs) Strong aptitude for computer systems What you will do: 1.Data governance of first level review of CP Raw materials and Recipes within a turnaround time of 72 hours 2. Provide Security Access roles to PDP/DMS /PPM/LIMS system with due diligence 3. Route Human Use Protocols (HUP) through SAP-DMS to the correct reviewers; support the process in Veeva as Admin. Route Adverse Event (AE) for all HUP studies to Pharmacovigilance team who will then perform an evaluation 4. Provide technical support and procedural guidance to 2000+ English-speaking PDM end-users via phone calls, emails and instant messages 5. Support Team in PDM Cleansing / Ancillary activities like Obsoleting recipes and Searches What you will learn: Core expertise on principles that govern data regarding our raw materials and recipes Elements of due diligence while providing access to SAP system users Functional Linkages - you will get an overview of how different departments are integrated into overall R&D eg: Analytical, R&I, Microbiology and implementation & support teams. Operational Excellence - Build on technical expertise, expanding it in complementary directions. Use technical expertise and creativity to proactively identify potential problems and address them using appropriate resources in discussion with team leads. You will also learn to integrate yourself into a high-performing team focused on balancing both execution and innovation. You will be coached for success on technical and soft skills. We will evaluate your progress periodically and ensure scheduled training sessions for your continued success during your traineeship at Colgate. Quality and Safety principles: At Colgate we strive for excellence in everything we do, Quality and safety is not far away. These principles are not only important for our trusted brands but also to our workplaces. You will be exposed to specific training on Q & S, to assure your trust while working in a safe environment where quality is paramount. Compensation and Benefits Salary Range $ - $ USD Pay is determined based on experience, qualifications, and location. Salaried employees may also be eligible for discretionary bonuses, profit-sharing, and long-term incentives for Executive-level roles. Benefits: Salaried employees enjoy a comprehensive benefits package, including medical, dental, vision, basic life insurance, paid parental leave, disability coverage, and participation in the 401(k) retirement plan with company matching contributions subject to eligibility requirements. Additional benefits include a minimum of 15 vacation/PTO days (hourly employees receive a minimum of 120 hours) and 13 paid holidays (vacation days are prorated based on the employee's hire date within the calendar year). Paid sick leave is adjusted based on role and location in accordance with local laws. Detailed information regarding paid sick leave entitlements will be provided to employees upon hiring and may be subject to adjustments based on changes in legislation or company policies. Our Commitment to Inclusion Our journey begins with our people—developing strong talent with diverse backgrounds and perspectives to best serve our consumers around the world and fostering an inclusive environment where everyone feels a true sense of belonging. We are dedicated to ensuring that each individual can be their authentic self, is treated with respect, and is empowered by leadership to contribute meaningfully to our business. Equal Opportunity Employer Colgate is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, ethnicity, age, disability, marital status, veteran status (United States positions), or any other characteristic protected by law. Reasonable accommodation during the application process is available for persons with disabilities. Please complete this request form should you require accommodation. For additional Colgate terms and conditions #LI-[[filter12]]