1158 Pharmacovigilance Jobs - Page 5

Skill required: Clinical Data Operations - Clinical Database Testing Designation: Clinical Data Svs Associate Qualifications: Master’s in actuarial science Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world s leading biopharma companies bring their vision to life and enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. The Clinical Testing Team is dedicated to conduct through validation of all clinical trial database components ensuring that database meets quality standards while remaining cost effective. Their responsibilities include reviewing requirement specification, developing test scripts for carious testing types, performing data entry according to these scripts, executing test steps, documenting results and maintaining comprehensive records of all tested components in compliance with regulatory requirements. Design and test EDC databases, create and maintain User Acceptance Testing (UAT) procedures for EDC systems, including the creation of test plans, verification of requirements for databases, eCRFs, edit checks, extractions, and reports. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Ability to establish strong client relationship Agility for quick learning Candidates who have completed Master s or Post graduate degree in Life Science domain (Biology, Genetics, Microbiology, Biochemistry, Biotechnology, and Ecology) in 2024 & 2025 (if all semester s results are available). Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Show more Show less

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. The incumbent will perform the regulatory operations tasks of bookmarking and hyper linking for granular components (documents) of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components. Collect, collate and evaluate the scientific data gathered as part of R & D. Advise on legal and scientific restraints and requirements. Ensure the organization`s products comply with current regulations. Example; Build regulatory submission strategy, author CMC documents, and health authority packages etc. What are we looking for? Ability to meet deadlines Ability to perform under pressure Ability to work well in a team Adaptable and flexible Agility for quick learning Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Show more Show less

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. The incumbent will perform the regulatory operations tasks of bookmarking and hyper linking for granular components (documents) of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components. Collect, collate and evaluate the scientific data gathered as part of R & D. Advise on legal and scientific restraints and requirements. Ensure the organization`s products comply with current regulations. Example; Build regulatory submission strategy, author CMC documents, and health authority packages etc. What are we looking for? Ability to meet deadlines Ability to perform under pressure Ability to work well in a team Adaptable and flexible Agility for quick learning Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Show more Show less

Skill required: Clinical Data Services - Clinical Database Programming 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 and review complex edit checks, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. 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: Data Review Report Programmers: Overall experience of 4+ years in Clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry preferred. Participate in the lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders. Facilitate interaction with end user on creating specifications and working with programmers or performing the programming activities for successful delivery. Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, SAS, and JReview etc. preferred. Show more Show less

Title We are currently seeking a full-time, office-based Clinical Safety Coordinator to join our Clinical Safety department in India. This position will be focused on the handling and processing of adverse events from all sources, including clinical trials and post marketing surveillance. 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 Determine plan of action for incoming calls; Collect, process, and track incoming adverse and serious adverse events; Write safety narratives; Report on various safety data; and Collaborate with internal departments and investigative clinical research sites to ensure compliance with safety processes. Qualifications Bachelor's degree in Healthcare related field; Nursing, Pharmacy, Pharmacology, etc Clinical experience or Clinical Research, case processing and Post marketing Pharmacovigilance experience is preferred; Proficient English is required Proficient knowledge of Microsoft® Office; Broad knowledge of medical terminology; and Strong organizational and communication skills. 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 activities are growing rapidly, and we are currently seeking a full-time, office-based Data Coordinator to join our Data Management team in India, Mumbai. If you want an exciting career where you 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 Track and maintain metrics regarding the status of the data within EDC systems Clean the clinical database, which includes generating and resolving data clarifications Reconcile clinical data Assist with support activities for the Data Management department Qualifications Bachelor’s degree in life science/ pharmacy/ health related field with strong attention to detail and working knowledge of Excel and Word; Minimum 1-2 years of clinical data management experience Knowledge of medical terminology and Clinical Research is preferred; and Good knowledge about the Clinical Databases (Medidata RAVE 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.

Project Role: Pharmacovigilance Tester Work Experience: 2+ years Work location: Noida, Hyderabad and Bangalore Mode of work: Hybrid Job Summary: The Argus/IVP Tester is responsible for ensuring the seamless integration, accuracy, and performance of safety data management systems, particularly in relation to Oracle Argus and IVP (Intake Validation Platform). The role involves designing, executing, and maintaining test cases and scenarios that validate data migration, transformation, and interface functionality between Argus and IVP. The tester will also work closely with cross-functional teams, including developers, business analysts, and project stakeholders, to identify and resolve defects, ensure compliance with regulatory requirements, and maintain high-quality deliverables. Essential Functions: 1. Test Planning and Design o Develop and document detailed test plans, test scenarios, and scripts for Argus and IVP data migration, transformation, and interface testing. o Create validation test protocols (VTPL) and user acceptance test (UAT) plans for system changes and updates. o Collaborate with business analysts to understand functional requirements and identify testing needs. 2. Test Execution o Perform end-to-end testing of data migration between Argus and IVP, ensuring accuracy and traceability of data transformations. o Execute test cases for system functionality, data validation, and interface integration across multiple environments. o Identify, log, and track defects to resolution while maintaining detailed documentation of testing outcomes. 3. Documentation and Reporting o Author and maintain standard operating procedures (SOPs), user functional requirement specifications (UFRS), and test execution summaries. o Generate and present comprehensive test reports, including defect analysis, risk assessments, and overall test coverage metrics. 4. Regulatory and Compliance o Ensure all testing activities comply with relevant regulatory standards, such as GxP and FDA 21 CFR Part 11. o Assist in preparing system validation documentation and support audits by providing testing artifacts and evidence. 5. Collaboration and Communication o Work closely with the development and tools teams to suggest design updates and improvements for system performance and usability. o Support change management processes, including Argus configuration changes and IVP intake modifications. o Act as a liaison between project stakeholders to align expectations and deliverables. 6. Continuous Improvement o Identify opportunities to improve testing processes, tools, and methodologies for enhanced efficiency and accuracy. o Stay updated with industry best practices, tools, and regulatory changes impacting Argus/IVP testing. . Show more Show less

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: Data governance of first level review of CP Raw materials and Recipes within a turnaround time of 72 hours Provide Security Access roles to PDP/DMS /PPM/LIMS system with due diligence 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 Provide technical support and procedural guidance to 2000+ English-speaking PDM end-users via phone calls, emails and instant messages 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, please click here. [[filter12]] Show more Show less

Job Overview Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations SOPs and internal guidelines under guidance and support of senior operation team members. Essential Functions To Prioritize and complete the assigned trainings on time. Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements. To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events(AE)/endpoint information determining initial/update status of incoming events database entry coding AE and Products, writing narratives, Literature related activities as per internal/ project timelines. Ensure to meet quality standards per project requirements. Ensure to meet productivity and delivery standards per project requirements. To ensure compliance to all project related processes and activities. Creating, maintaining and tracking cases as applicable to the project plan. Identify quality problems, if any, and bring them to the attention of a senior team member. To demonstrate problem solving capabilities. To mentor new teams members, if assigned by the Manager. Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes. 100% compliance towards all people practices and processes Perform other duties as assigned. Qualifications High School Diploma or equivalent Scientific or healthcare discipline or allied life sciences Req An Individual with a minimum of a Bachelor’s Degree in scientific or healthcare discipline or allied life sciences graduation with 1-1.5 years of relevant experience. Req Good knowledge of medical terminology. Intermediate Working knowledge of applicable Safety Database. Beginner Knowledge of applicable global, regional, local clinical research regulatory requirements. Beginner Excellent attention to detail and accuracy. Beginner Good working knowledge of Microsoft Office and web-based applications. Beginner Strong organizational skills and time management skills. Beginner Strong verbal/written communication skills. Intermediate Self-motivated and flexible. Intermediate Ability to follow instructions/guidelines, utilize initiative and work independently. Intermediate Ability to multi-task, manage competing priorities and deadlines. Beginner Ability to delegate to less experienced team members. Beginner Willingness and aptitude to learn new skills across Safety service lines. Beginner Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients. Beginner Ability to work as a Team Player, contribute and work towards achieving Team goals. Beginner Ensure quality of deliverables according to the agreed terms. Beginner Demonstration of IQVIA core values while doing daily tasks Beginner Extensive use of telephone and face-to-face communication requiring accurate perception of speech. Beginner Regular sitting for extended periods of time. Beginner May require occasional travel. Beginner Flexibility to operate in shifts. Beginner 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

Role Purpose The purpose of the role is to provide effective technical support to the process and actively resolve client issues directly or through timely escalation to meet process SLAs. Do Support process by managing transactions as per required quality standards Fielding all incoming help requests from clients via telephone and/or emails in a courteous manner Document all pertinent end user identification information, including name, department, contact information and nature of problem or issue Update own availability in the RAVE system to ensure productivity of the process Record, track, and document all queries received, problem-solving steps taken and total successful and unsuccessful resolutions Follow standard processes and procedures to resolve all client queries Resolve client queries as per the SLAs defined in the contract Access and maintain internal knowledge bases, resources and frequently asked questions to aid in and provide effective problem resolution to clients Identify and learn appropriate product details to facilitate better client interaction and troubleshooting Document and analyze call logs to spot most occurring trends to prevent future problems Maintain and update self-help documents for customers to speed up resolution time Identify red flags and escalate serious client issues to Team leader in cases of untimely resolution Ensure all product information and disclosures are given to clients before and after the call/email requests Avoids legal challenges by complying with service agreements Deliver excellent customer service through effective diagnosis and troubleshooting of client queries Provide product support and resolution to clients by performing a question diagnosis while guiding users through step-by-step solutions Assist clients with navigating around product menus and facilitate better understanding of product features Troubleshoot all client queries in a user-friendly, courteous and professional manner Maintain logs and records of all customer queries as per the standard procedures and guidelines Accurately process and record all incoming call and email using the designated tracking software Offer alternative solutions to clients (where appropriate) with the objective of retaining customers and clients business Organize ideas and effectively communicate oral messages appropriate to listeners and situations Follow up and make scheduled call backs to customers to record feedback and ensure compliance to contract /SLAs Build capability to ensure operational excellence and maintain superior customer service levels of the existing account/client Undertake product trainings to stay current with product features, changes and updates Enroll in product specific and any other trainings per client requirements/recommendations Partner with team leaders to brainstorm and identify training themes and learning issues to better serve the client Update job knowledge by participating in self learning opportunities and maintaining personal networks Deliver NoPerformance ParameterMeasure1ProcessNo. of cases resolved per day, compliance to process and quality standards, meeting process level SLAs, Pulse score, Customer feedback2Self- ManagementProductivity, efficiency, absenteeism, Training Hours, No of technical training completedMandatory Skills: Pharmacovigilance & Drug Safety(Pharma).

Job Overview Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations SOPs and internal guidelines under guidance and support of senior operation team members. Essential Functions To Prioritize and complete the assigned trainings on time. Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements. To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events(AE)/endpoint information determining initial/update status of incoming events database entry coding AE and Products, writing narratives, Literature related activities as per internal/ project timelines. Ensure to meet quality standards per project requirements. Ensure to meet productivity and delivery standards per project requirements. To ensure compliance to all project related processes and activities. Creating, maintaining and tracking cases as applicable to the project plan. Identify quality problems, if any, and bring them to the attention of a senior team member. To demonstrate problem solving capabilities. To mentor new teams members, if assigned by the Manager. Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes. 100% compliance towards all people practices and processes Perform other duties as assigned. Qualifications High School Diploma or equivalent Scientific or healthcare discipline or allied life sciences Req An Individual with a minimum of a Bachelor’s Degree in scientific or healthcare discipline or allied life sciences graduation with 1-1.5 years of relevant experience. Req Good knowledge of medical terminology. Intermediate Working knowledge of applicable Safety Database. Beginner Knowledge of applicable global, regional, local clinical research regulatory requirements. Beginner Excellent attention to detail and accuracy. Beginner Good working knowledge of Microsoft Office and web-based applications. Beginner Strong organizational skills and time management skills. Beginner Strong verbal/written communication skills. Intermediate Self-motivated and flexible. Intermediate Ability to follow instructions/guidelines, utilize initiative and work independently. Intermediate Ability to multi-task, manage competing priorities and deadlines. Beginner Ability to delegate to less experienced team members. Beginner Willingness and aptitude to learn new skills across Safety service lines. Beginner Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients. Beginner Ability to work as a Team Player, contribute and work towards achieving Team goals. Beginner Ensure quality of deliverables according to the agreed terms. Beginner Demonstration of IQVIA core values while doing daily tasks Beginner Extensive use of telephone and face-to-face communication requiring accurate perception of speech. Beginner Regular sitting for extended periods of time. Beginner May require occasional travel. Beginner Flexibility to operate in shifts. Beginner Office based Need to join as soon as possible 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

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 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 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 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.