417 Ich-Gcp Guidelines Jobs - Page 11

Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do :Experience working in Client On-boarding, Account Maintenance, Customer Identification Program (CIP) and Know Your Customer (KYC) processes.Conducting PEPs (Politically Exposed Persons) screening and adverse media checksProven analytical skills, problem solving ability, and a control mentality paired with meticulous attention to detail.Aptitude for building relationships and ability to communicate complex issues to a wide array of internal clients with differing levels of product experience.Self-motivated and proactive team player who takes ownership and accountability & has strong organizational skills as well as the ability to effectively manage competing priorities.Flexible and able to work well under pressure, manage high volumes, and collaborate with a global team while maintaining a positive attitude.Proficiency using the Microsoft Office Suite in particular Excel, PowerPoint and Microsoft Word.Business and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding and/or maintaining a business / customer relationship. This includes driving customer identification, customer due diligence & enhanced due diligence. What are we looking for Know Your Customer (KYC) Operations:Educated to Degree LevelFamiliar with a wide range of external data sources and third-party systems to be covered as a part of the due diligence process.Relevant financial service experience, ideally within risk, compliance or financial crime.A good understanding of effective risk managementExperience of working with high-risk client groupsKnowledge of the regulatory environment is highly desirableStrong analytical ability and attention to detail and strong research skills and experience with the Internet and on-line research systemsDetail oriented, with the ability to work independently and multi-task effectivelyExcellent written and verbal communication skillsFlexible to work in rotation shifts, time management, and ability to prioritize and work effectively to tight deadlines 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 Qualification Any Graduation

Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do :Experience working in Client On-boarding, Account Maintenance, Customer Identification Program (CIP) and Know Your Customer (KYC) processes.Conducting PEPs (Politically Exposed Persons) screening and adverse media checksProven analytical skills, problem solving ability, and a control mentality paired with meticulous attention to detail.Aptitude for building relationships and ability to communicate complex issues to a wide array of internal clients with differing levels of product experience.Self-motivated and proactive team player who takes ownership and accountability & has strong organizational skills as well as the ability to effectively manage competing priorities.Flexible and able to work well under pressure, manage high volumes, and collaborate with a global team while maintaining a positive attitude.Proficiency using the Microsoft Office Suite in particular Excel, PowerPoint and Microsoft Word.Looking for someone with KYC experience along with ECDD/OCDD knowledgeBusiness and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding and/or maintaining a business / customer relationship. This includes driving customer identification, customer due diligence & enhanced due diligence. What are we looking for Know Your Customer (KYC) Operations:Educated to Degree LevelFamiliar with a wide range of external data sources and third-party systems to be covered as a part of the due diligence process.Relevant financial service experience, ideally within risk, compliance or financial crime.A good understanding of effective risk managementExperience of working with high-risk client groupsKnowledge of the regulatory environment is highly desirableStrong analytical ability and attention to detail and strong research skills and experience with the Internet and on-line research systemsDetail oriented, with the ability to work independently and multi-task effectivelyExcellent written and verbal communication skillsFlexible to work in rotation shifts, time management, and ability to prioritize and work effectively to tight deadlines 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 Qualification Any Graduation

Role & responsibilities: Issue of Study Documents, SOPs, Work Instructions, Method Procedures, Test Procedures, Forms, Manuals & Logbooks. Archival and Retrieval of study documents & General Documents. Maintenance of Sops work instructions, Forms, Manuals, Bincards, Logbooks and general documents indexes. Maintenance of studies archival list with third party (WIMS). Obsoletion of Sops, work instructions, Forms & general data scanned & Ture copy certification. X-Ray evaluations year wise verified. Screening failures & Validity completed documents are arranged & scanned, verified true copy certification. Agreements, vendors, consultants due dates verification and maintenance of indexes. All department Sops review dates also maintained ii year wise. Maintenance of all employee training records with hard copy and scan copies. Maintenance of study documents, general documents and sent to archival for third party WIMS. Updating indexes of archival racks for identifying study and general documents. Maintenance of all left employee training records with hard copy and scan copies verified and done by true copy certification. Maintenance and archival of Calibrations, Qualification and Method Validations general files along with updated index labels. All other activities assigned by department head as per requirements. Preferred candidate profile: Interested and suitable applicants can mail their updated CV to hr@qpsbioserve.com. Note: We are looking for candidate who are willing to join on immediately.

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: Bachelor of Pharmacy Years of Experience: 0 to 1 years Language - Ability: English - Advanced About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.In this role, you will be expected to 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 In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy

Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Specialist Qualifications: BE/BTech/MCA Years of Experience: 7 to 11 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.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.In this role, you will be expected to develop clinical trial reports using SAS/ J-review / Congnos / SQL / PLSQL as per the study requirement. What are we looking for SAS ClinicalOracle Procedural Language Extensions to SQL (PLSQL)Python (Programming Language)R ProgrammingClinical Database ProgrammingAdaptable and flexibleAbility to perform under pressureProblem-solving skillsAgility for quick learningAbility to establish strong client relationship Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualification BE,BTech,MCA

Lilavati Medical Center is looking for Clinical Associate - Radiology to join our dynamic team and embark on a rewarding career journey Perform and interpret diagnostic imaging procedures, including X-rays, MRI, CT scans, and ultrasounds. Provide expert consultation to other physicians regarding radiologic findings. Ensure high-quality imaging and patient safety. Stay updated with advancements in radiology technology and techniques. Participate in multidisciplinary team meetings to discuss patient care plans. Conduct research and contribute to radiology publications. MD/DNB (Radiology) with post graduate experience from a reputed Hospital.

www.inductivequotient.com Director Clinical Data Management About Us: Inductive Quotient was founded by statisticians and technology industry experts with over 20 years of experience Inductive quotient aims to transform businesses and processes with its advanced digitization capabilities. With advanced AI and Machine Learning techniques we are helping Life Sciences industry to create a better healthcare system, and our Data Science capabilities helps organizations to create breakthrough solutions to transform businesses and drive sales growth. Website: www.inductivequotient.com Position: Clinical Data Management Director Requirement: Immediate Joiner Location: Hyderabad Mode: Work from office. Job description: We are seeking an experienced Director, Clinical Data Management with over 13 years of progressive experience in clinical data management within a CRO environment. The ideal candidate will lead the clinical data management team, oversee complex clinical trials, and ensure the delivery of high-quality, compliant data to support clinical development programs. Key Responsibilities: Provide strategic leadership and oversight to the clinical data management (CDM) team across multiple therapeutic areas and complex clinical trials. Develop and implement data management plans, standards, and procedures to ensure data quality, accuracy, and integrity. Collaborate closely with Clinical Operations, Biostatistics, Medical Writing, and Regulatory teams to support clinical trial planning and execution. Ensure compliance with ICH-GCP, FDA, EMA, and other regulatory requirements governing clinical data management. Mentor, develop, and lead a team of data managers and coordinators, fostering a culture of continuous learning and professional development. Review and approve key data management deliverables such as Data Management Plans (DMP), CRF designs, data validation specifications, and study reports. Support audits and inspections conducted by regulatory authorities and clients. Act as a key point of contact for clients on data management-related matters, ensuring excellent customer service and communication. Contribute to business development activities, including proposal writing and client presentations. Lead the development and execution of data strategy to align with overall clinical development objectives and timelines. Oversee the integration of new technologies, such as AI and machine learning tools, to enhance data quality and efficiency. Establish and maintain key performance indicators (KPIs) and metrics to monitor the effectiveness and productivity of the data management function. Collaborate with IT and software development teams to customize and optimize clinical data systems and tools. Ensure timely resolution of data queries and discrepancies to minimize delays in database lock and study close-out. Drive data governance and data privacy initiatives to comply with GDPR, HIPAA, and other data protection regulations. Lead cross-functional risk assessments and implement mitigation strategies related to clinical data integrity. Represent the clinical data management function in leadership meetings and contribute to strategic planning. Support training programs for new hires and provide continuous education to the CDM team to keep pace with industry trends. Participate in post-study data review and contribute to the publication of clinical trial results. Document lessons learned and best practices to improve future studies. Manage timelines, budgets, and resource allocation for the clinical data management department. Drive process improvements and implement industry best practices and innovative technologies in data capture, validation, and reporting. Oversee vendor selection, management, and performance evaluation for external data management services and EDC providers. Qualifications: Bachelors degree in Life Sciences, Pharmacy, or a related field; advanced degree preferred. Minimum of 13 years of clinical data management experience in a CRO or pharmaceutical setting. Proven leadership experience managing large teams and multiple projects simultaneously. Proficiency with EDC systems (e.g., Medidata Rave, Veeva, Oracle Clinical, Trial Master) and clinical data management tools. Deep knowledge of clinical trial processes, CDISC standards, and regulatory requirements (ICH-GCP, FDA, EMA). Strong project management skills, including budgeting and resource planning. Excellent communication, interpersonal, and client management skills. Ability to work effectively in a fast-paced, dynamic environment and drive cross-functional collaboration. Experience with risk-based monitoring and data quality initiatives is a plus. Maintain up-to-date knowledge of industry standards and regulatory requirements. Excellent organizational skills and ability to manage multiple projects simultaneously. Why Inductive Quotient? We are team a of 75 + talented and passionate professionals with strong statistical and analytical background combined with required study expertise. We IQians take lots of pride in our culture that enables open and creative thinking, deeply valuing our employees and their contributions towards our organization success.

We are a company dedicated to the audit and certification of national and international standards of quality and sustainability in products and processes.. We have an interdisciplinary team of professionals specialized in each industry and sector, committed to providing the highest quality service in a personalized way, generating long-term relationships with our clients and the community.. Our wide service offer, our extensive network of producers, processors and traders, our presence in fairs and seminars in different countries and our growing internationalization, make LETIS a link to the world.. Brief Job Description:. Audit preparation. Audit report preparation. Responding to technical queries.. Sending Audit Packs to Certifying office within stated timeline. Submission of Updated Audit Logs. Technical accuracy as per guidelines of audits packs. Client Satisfaction. Sociable with good market recognition and understanding. Technical Knowledge on the food sector audited. Presentable with the right mix of authority and convincing capability. Analytical capability and prompt decision making capability. Qualifications:. Essential:. Graduate/ Post Graduate in careers related to Agronomy Engineering or registered Rural Administration Technician, etc.;. To have knowledge and skills in organic production and handling techniques. At least 2 years of experience as an organic inspector in another Certifying Body (preferably in NOP regulations). Intermediate-advanced level of English (B2-C1). Desirable:. Food industry work experience with knowledge/ experience in auditing food safety management systems. with good Communication Skills , pleasing personality and proficient in computer usage. Please note it is mandatory to attach an audit log of audits conducted during your career, as well as professional references.. Show more Show less

Ideal candidate will prepare error-free DMF submissions to regulatory authorities. Manage amendments and annual reports, address regulatory queries, ensure compliance in development/validation, assess impurities. Required Candidate profile Please apply only if your qualifications match the requirements.

Role & responsibilities Review and submission of ANDA 505 (J) application for US market. CMC writing, Query management, Labeling, RIMS, Drug Listing, Pre-and Post-Approval Changes (Life cycle management) and Publishing as per USFDA/EU. Proficient in cross functional team communication with internal and external stakeholders. Functional experience in end to end project management and handling team Preferred candidate profile Candidate must have experience in Regulatory filling and product life cycle management for in EU & US markets Perks and benefits 20lpa to 30 lpa

Paytm is India's leading mobile payments and financial services distribution company. Pioneer of the mobile QR payments revolution in India, Paytm builds technologies that help small businesses with payments and commerce. Paytm’s mission is to serve half a billion Indians and bring them to the mainstream economy with the help of technology. About the team Oil & Gas This team is directly responsible for growth of Oil and Gas offline transactions & users at Paytm. About the role Team Leader To work with the business to understand and manage Programs being run for the Clients/Brands. And for accelerating the core growth metrics focusing on sales & distribution. Provides guidance and instruction to a working group about a project or portfolio of projects. These leaders are responsible for monitoring the efforts of the team members and getting the work done effectively and efficiently with the proper utilization of resources. Skills that will help you succeed in this role: 2+ yrs. of experience in Distribution sales in fintech, Banking/ Sales, EDC Sales. Develop plans and strategies for developing business and achieving the company's sales goals. Create a culture of success and ongoing business and goal achievement. Manage the sales teams and resources to deliver growth. Hire and build a new team to support our growing needs and future projects. Define optimal sales force structure. Define and coordinate sales training programs that enable staff to achieve their potential and support company sales objectives. Manage customer expectations and contribute to a high level of customer satisfaction. Define sales processes that drive desired sales outcomes and identify improvements. Going to the Merchant and educating him/her about the benefits of the Swipe machine (EDC) converting them and managing their accounts. Exceptional communication, presentation skills and relationship building skills. Ability to aggressively manage the successful execution of a sales strategy. Ability to work independently and collaboratively in a team environment. Qualifications: Bachelor's degree in business, marketing, or a related field (MBA preferred). Should have a strong understanding of the local language. Self-motivated and goal-oriented, with a demonstrated ability to work independently and as part of a team. Willingness to travel as needed to meet with clients and attend industry events.

We are looking for a highly skilled and experienced Receivable Executive to join our team at Equitas Small Finance Bank. Roles and Responsibility Manage and oversee the receivables process to ensure timely payments and minimize bad debts. Develop and implement effective strategies to improve receivables management. Collaborate with cross-functional teams to resolve customer complaints and issues. Analyze and report on receivables performance metrics to senior management. Identify and mitigate risks associated with receivables operations. Ensure compliance with regulatory requirements and internal policies. Job Requirements Strong knowledge of financial regulations and laws governing the BFSI industry. Excellent communication and interpersonal skills for working with customers and stakeholders. Ability to analyze data and provide insights to inform business decisions. Strong problem-solving and analytical skills to resolve complex issues. Experience with accounting software and systems is desirable. Ability to work in a fast-paced environment and meet deadlines.

We are looking for a highly skilled and experienced Receivable Executive to join our team at Equitas Small Finance Bank. Roles and Responsibility Manage and oversee the receivables process to ensure timely payments and minimize bad debts. Develop and implement effective strategies to improve receivables management. Collaborate with cross-functional teams to resolve customer complaints and issues. Analyze and report on receivables performance metrics to senior management. Identify and mitigate risks associated with receivables operations. Ensure compliance with regulatory requirements and internal policies. Job Requirements Strong knowledge of financial regulations and laws governing the BFSI industry. Excellent communication and interpersonal skills for working with customers and stakeholders. Ability to analyze data and provide insights to inform business decisions. Proficiency in using accounting software and systems for managing receivables. Strong problem-solving skills to resolve complex customer issues. Experience in managing and leading a team to achieve business objectives.

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

Paytm is India's leading mobile payments and financial services distribution company. Pioneer of the mobile QR payments revolution in India, Paytm builds technologies that help small businesses with payments and commerce. Paytm’s mission is to serve half a billion Indians and bring them to the mainstream economy with the help of technology. About the team Oil & Gas This team is directly responsible for growth of Oil and Gas offline transactions & users at Paytm. About the role Team Leader To work with the business to understand and manage Programs being run for the Clients/Brands. And for accelerating the core growth metrics focusing on sales & distribution. Provides guidance and instruction to a working group about a project or portfolio of projects. These leaders are responsible for monitoring the efforts of the team members and getting the work done effectively and efficiently with the proper utilization of resources. Skills that will help you succeed in this role: 2+ yrs. of experience in Distribution sales in fintech, Banking/ Sales, EDC Sales. Develop plans and strategies for developing business and achieving the company's sales goals. Create a culture of success and ongoing business and goal achievement. Manage the sales teams and resources to deliver growth. Hire and build a new team to support our growing needs and future projects. Define optimal sales force structure. Define and coordinate sales training programs that enable staff to achieve their potential and support company sales objectives. Manage customer expectations and contribute to a high level of customer satisfaction. Define sales processes that drive desired sales outcomes and identify improvements. Going to the Merchant and educating him/her about the benefits of the Swipe machine (EDC) converting them and managing their accounts. Exceptional communication, presentation skills and relationship building skills. Ability to aggressively manage the successful execution of a sales strategy. Ability to work independently and collaboratively in a team environment. Qualifications: Bachelor's degree in business, marketing, or a related field (MBA preferred). Should have a strong understanding of the local language. Self-motivated and goal-oriented, with a demonstrated ability to work independently and as part of a team. Willingness to travel as needed to meet with clients and attend industry events.

for Risk & Compliance New Associate Position Title:Risk & Compliance New Associate CL -13 Location: Bengaluru Employment Type: Full Time Must have skills : Risk & Compliance Good to have skills : Compliance About CF/S&C Corporate Functions include Human Resources, Finance, Legal, Marketing Communications, and Workplace Solutionsthat power Accenture's people across industries and functions to keep our business leading in the New. Join the heart and soul of Accenture, partnering with our extraordinary people to bring innovation into every organization. Combining unmatched experience and specialized skills across more than 40 industries, the company offers Strategy and Consulting, Song (Interactive), Technology and Operations servicesall powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. With net revenues of $64 billion for 2023, their 774,000+ employees deliver on the promise of technology and human ingenuity every day, serving clients in more than 49 countries and over 200 cities. Job Summary : The Risk & Compliance Manager is responsible for identifying, assessing, and mitigating potential organizational risks. They develop and implement risk management plans and ensure the organization complies with relevant laws, regulations, and internal policies. Roles & Responsibilities: Good Communication skills Candidate should have good excel skills. Adaptable and flexible Maintain and update compliance calendar, trackers, periodical reports, and repositories. Knowledge of labour Laws Strong analytical and problem-solving skills. Attention to detail and ability to work independently. Familiarity with regulatory requirements and compliance standards. Monitor and report on compliance issues and risks. Job Qualification: Additional Information: - The ideal candidate will possess a strong educational background in Law or a related field, along with good knowledge and experience in relevant country compliance. This position is based at our Bengaluru office. Qualification Experience: Minimum 1 - 2 year(s) of experience is required Educational Qualification: LLB

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Specialist Qualifications: MBBS/MD Years of Experience: 3 to 5 years Language - Ability: English(International) - Proficient About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Performs Medical Assessment activities related to drug safety Pharmacovigilance for the Individual Case Safety Reports- Responsible to perform Medical Review of ICSRs according to the client SOPs/Manuals- Prioritizes the cases according to Regulatory clock date, Seriousness criteria and ensure the cases are completed according to the timelines mentioned in client SOP- Performs review of all applicable Medical Review Fields and ensures accuracy - Plan, organize and manage daily work to meet the service level timelines and deliverables- Review MedDRA coding of reported terms in Cases, suggest additional events to be added wherever necessary - Causality assessment of serious cases and relevant non-serious cases with Company Remarks wherever applicable- Performs labelling of events of applicable cases- Provides Medical Expertise to case processing team whenever required- Provides training/mentoring to the team members wherever applicableCreate 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 Understanding of PharmacovigialnceExperience in Medical Review of ICSRsMedical Review Roles and Responsibilities: - Responsible to perform Medical Review of ICSRs according to the client SOPs/Manuals- Prioritizes the cases according to Regulatory clock date, Seriousness criteria and ensure the cases are completed according to the timelines mentioned in client SOP- Performs review of all applicable Medical Review Fields and ensures accuracy - Plan, organize and manage daily work to meet the service level timelines and deliverables- Review MedDRA coding of reported terms in Cases, suggest additional events to be added wherever necessary - Causality assessment of serious cases and relevant non-serious cases with Company Remarks wherever applicable- Performs labelling of events of applicable cases- Provides Medical Expertise to case processing team whenever required- Provides training/mentoring to the team members wherever applicable Qualification MBBS,MD

Roles and Responsibilities Responsible for Analytical Method Validation. Responsible for HPLC/GC instrument handling. Responsible for Daily review of Analytical balance and Daily Temperature monitoring. Responsible to follow analytical procedures and generate online raw data. Responsible for Stability Studies and Analysis. Responsible to operate and analyze of raw materials, In Process, cleaning samples, samples for vendor qualification, Stability samples, standard and Finish product Samples and instrumental method (HPLC / UPLC / GC) and to perform analysis of process validation. Responsible for Daily verification of analytical balance and daily temperature monitoring. Online entry in logbooks of instrument, column, working standard, chemical inventory whenever use. Responsible for in process data review in night shift. Finished product sample receive, entry taken in register and maintain daily status. Responsible to follow all the Standard operating procedures, to give Instructions for housekeeping, cleaning and maintaining the laboratory area. Responsible to follow all the analytical procedures and generates online raw data, Chromatograms, calculation sheets and charts with reviewer signature. Responsible to control and maintain records like protocols, Specification, Standard test procedure, Analytical work record, Standard operation procedure, In- process analysis records, usage log books and status labels during day to day Analysis. Responsible to perform calibration and maintain its records. Responsible to Prepare and maintain record of finished product. Responsible to maintain record of chemicals, glass wares and other lab items of department. Responsible for cleaning, maintenance, and daily calibration of specified instruments. Responsible to maintain records and qualification of primary standards, reference standards and working standards. Responsible for reporting to senior if any abnormality observed during analysis and perform for the out of specification and to investigate the OOS (Out of specification) or OOT (Out of trend)if found and Responsible for maintaining QMS related documents. Responsible to follow various EHS (Environment Health and safety) guideline and use appropriate PPEs (Personal protective equipments) . . Desired Candidate Profile Candidate Should be from Pharma background Candidate Should have excellent knowledge of ICH Guidelines Prefer Who can work in a shift and willing to relocate in Navsari, Gujarat Candidate should have Work Accuracy.

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for Affiliate Team AssociateAffiliate Team Associate 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 Qualification Bachelor of Pharmacy,Master of Pharmacy

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 Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for 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 Qualification BSc,Bachelor of Pharmacy

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy Years of Experience: 1 to 3 years Language - Ability: English(International) - Advanced About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do 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.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.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. What are we looking for 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.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. 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 Qualification Bachelor of Pharmacy

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Sr Analyst Qualifications: Bachelor of Pharmacy Years of Experience: 5 to 8 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.In this role, you will be expected to 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 Ability to establish strong client relationshipAbility to work well in a teamCollaboration and interpersonal skills Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy

Skill required: Record to Report - Account Reconciliations Designation: New Associate Qualifications: BCom Years of Experience: 0 - 1 Years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Finance Operations vertical and will be helping us in determining financial outcomes by collecting operational data/reports, whilst conducting analysis and reconciling transactions. The Record to Report team helps clients and organizations in their operational efficiency and balance sheet integrity, cuts time to close and safeguards compliance with regulatory requirements. The areas where this team's expertise lies is in posting journal entries, preparing balance sheet reconciliations, reviewing entries and reconciliations, preparing cash forecasting statement, supporting month end closing, preparing reports and supports in audits. A type of general ledger account which contains a summary of sub-ledger accounts. Because the reconciliation account only provides a summary, no transactions are directly posted to the account. What are we looking for Account Reconciliations Adaptable and flexible Product Costing and Inventory 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 Qualification BCom

SUMMARY SAR & SAR-like Patient Safety Physician Job Description Responsible for compiling PBRERs with a focus on medical aspects and safety sections of products, and analyzing safety trends, including source data analysis based on queries Assisting in identifying, analyzing, and drawing conclusions from safety data for cumulative trends Collaborating with Therapeutic Head to identify signals and address product safety concerns Engaging with Therapeutic Area colleagues for enhanced understanding and development Measurable Goals Ensuring 100% compliance with timely completion of all client and Cognizant required trainings Achieving 100% compliance with work allocation plan, including case closure based on agreed timelines and quality benchmarks Non - Measurable Attributes Self - motivated Goal-oriented Interdepartmental collaboration Personal grooming and etiquette Punctuality Team player and process-oriented Competencies Proficient in delivering presentations Effective at collaborating across different cultures Strong preference for structured and process-driven tasks Committed to completing training and documentation on time Experience Relevant educational background and experience in patient safety or related field Required Skills Strong presentation and communication skills Effective intercultural work capabilities Commitment to timely completion of tasks and documentation Analytical and problem-solving skills Collaboration and teamwork abilities Requirements Requirements: Relevant educational background and experience in patient safety or related field Strong presentation and communication skills Effective intercultural work capabilities Commitment to timely completion of tasks and documentation Analytical and problem-solving skills Collaboration and teamwork abilities

Title Our global activities are growing rapidly, and we are currently seeking a full-time, office-based Clinical Database Programmer to join our Core Labs team in Mumbai, India. This position will work in 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 programmer 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 Develop, program, validate and maintain clinical trial databases according to company standards; Maintain and prepare data models such as electronic CRFs and program editing checks; Act as primary programmer contact to the data management team for assigned studies, supplying all necessary technical support, and ensuring quality of the programming and adherence to company standards. Qualifications A minimum of a Bachelor's degree is required (preferably in a math or information science field); Flexibility and ability to manage multiple priorities simultaneously; Excellent verbal and written communication skills; ability to work in a team environment with data managers, data coordinators, statisticians, and programmers; Meticulous attention to detail. Familiarity with programming languages such as C# and SQL 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.