417 Ich-Gcp Guidelines Jobs - Page 3

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

We are seeking a talented individual to join our Insurance Operations team at Marsh. This role will be based in Mumbai. This is a hybrid role that has a requirement of working at least three days a week in the office. Senior Manager Insurance Operations (Grade E) Were seeking a Senior Manager Insurance Operations who is prepared to manage a team responsible for complex and varied insurance tasks. This role is critical in fostering a culture of excellence, ensuring operational efficiency, and driving the performance of multiple teams. The ideal candidate will possess a strong background in the insurance sector or related industries, with a proven ability to manage diverse teams working with teammates across geographical boundaries and implement best practices that align with our organizational goals. This is an opportunity to put your stamp on an operations team that is evolving to meet the needs of a growing business We will count on you to: Operational Excellence Foster a collaborative team environment by promoting strong relationships and open communication between team members and colleagues in other countries, ensuring a cohesive and inclusive atmosphere across all locations. Lead and mentor a team of Team Managers, ensuring they effectively oversee their respective teams of 15 colleagues each. Play a key role in building and transitioning functional capabilities to the service center, ensuring that all colleagues are aligned with the organizations culture and services. Identify and address knowledge gaps within teams, conducting regular training refreshers and evaluations to ensure retention of critical learnings. Develop and implement strategies to maintain service level agreements (SLAs) while maintaining high-quality standards for all processes. Partner with leaders in Operations and Underwriting to deliver consistent and high-quality work products and results. Identify and adapt industry best practices and adapt them to meet our specific needs driving continuous improvement. Analyze current processes to identify problem areas and develop preventive measures to enhance operational effectiveness. Determine the most effective methods and channels to address various training needs across teams, ensuring alignment with organizational objectives. Ensure adherence to performance metrics and compliance with training requirements, including conducting monthly evaluations and assessments. Ensure that all statutory regulations and company procedures are followed to protect customers, colleagues, and the business interests of the company. Maintain a clear understanding of regulatory requirements and proactively ensure compliance with the regulatory and risk framework. Monitor and assess risks appropriately, recognizing the impact of actions on compliance and operational integrity. Timely highlight process challenges and operational issues, facilitating effective communication between teams and senior leadership. Provide regular updates on team performance, process improvements, and compliance status to senior management. People Management/ Development Lead the recruitment and selection process for team members, ensuring alignment with organizational values and culture. Serve as a mentor to new hires, facilitating their integration into the team. Develop and implement training programs for Team Leaders and Operations Managers, focusing on leadership skills, operational excellence, and team dynamics. Provide ongoing coaching to enhance their capabilities and performance. Conduct regular performance evaluations and provide constructive feedback to team leaders, fostering a culture of continuous improvement and accountability. Identify high-potential employees and create development plans to prepare them for future leadership roles. What you need to have: Bachelors Degree or equivalent education and work experience. Strong proficiency is both spoken and written English. Excellent computer skills and proficient MS Office (Excel, Word, PowerPoint, Outlook, MS Teams) A minimum of 10-12 years of experience in team leadership, preferably within the insurance industry or a related field. Proven experience managing multiple teams and driving performance in a fast-paced environment. Strong analytical and problem-solving skills, with a focus on process improvement and operational efficiency. Excellent communication and interpersonal skills, with the ability to engage and motivate diverse teams. A solid understanding of compliance, regulatory requirements, and risk management principles. Ability to work collaboratively with senior leaders and stakeholders to achieve strategic objectives while fostering a sense of unity and teamwork among international teams. Willingness to work in 2.30PM to 11.30PM or 6:30 PM to 3:30 AM shift What makes you stand out: Insurance certification from The Institutes, USA. Post-Graduation/Certificate Courses in Insurance. Prior experience with insurance processes.

About The Role 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 Drug saftey 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

About The Role 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 Good Communication Skills Roles and Responsibilities: 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 Qualification Any Graduation

About The Role Skill required: Com.Bkg- Commercial Real Estate - Real Estate Due Diligence Designation: Banking Advisory Senior Analyst Qualifications: BCom Years of Experience: 5 to 8 years Language - Ability: English(Domestic) - Intermediate 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 We help clients address quality and productivity issues, keep pace with customer expectations, navigate regulatory and operational pressures and ensure business sustainability by transforming their banking operations into an agile, resilient operating model.The Corporate banking /Wholesale banking team is responsible for helping clients and organizations processes trade finance transactions by providing superior service delivery to trade customers whilst safeguarding the bank from risks associated with this business.Identify and assess, prevent and mitigate and account to provide reasonable measures to adapt before executing an agreement in relation to the real estate and immovable property. Valuation of commercial real estate using software like Argus, extracting key information from lease agreements (including amendments) and rent rolls. What are we looking for Ability to handle disputesAbility to meet deadlinesAbility to perform under pressureAbility to work well in a teamAdaptable and flexible 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 BCom

About The Role 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 Drug Safety AssociateDrug Safety 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: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance New Associate Qualifications: Any Graduation Years of Experience: 0 to 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 Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model powered by data, intelligent technologies and talentLooking 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 Communication SkillsIn 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 shiftsStrong coping, emotional resilience, and stress-management skillsExcellent comprehension and communication Ability to perform duties objectively, devoid of inherent biases or personal beliefs, in the best interest of client policies Strong attention to detail Comfort synthesizing and analyzing information from multiple streams Strong critical thinking and decision-making skills Qualification Any Graduation

About The Role Skill required: AML fraud mgmt. Financial Crime & Fraud Management Designation: Regulatory Compliance Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years What would you do? The Risk & Controls Analyst will be a key member of the Client s Operations Team, supporting the day-to-day management of the First Line of Defense risk management framework and related activities.This role involves working collaboratively across the bank to identify, assess, monitor, and mitigate operational risks.Strategize, architect, Analyse, design, implement and contribute to engagements involving tools and processes associated with the prevention (or management ) of fraud What are we looking for? Written and verbal communicationBanking, Financial Services4+ year of BFSI experience with atleast 3 years in AML Name / Transaction Screening operations and 1 year as QC Perform detailed data gathering and analyse the gathered dataResponsible for conducting Name / PEP / Adverse media / Enforcement / Payment screening against WatchlistsCompliance with regulations and attainment of client specific processing requirements Perform quality checks on completed analyst/senior analyst filesProvide SME guidance to AnalystsEstablish and maintain excellent working relationships with stakeholders at all levelsFraud Risk ManagementSanctions ScreeningEducated to Degree LevelMinimum of 3 years experience of working with KYC / AML screening teamMinimum of 1 years experience as a Checker is preferredRelevant financial service experience, ideally within risk, compliance or financial crime.Knowledge or experience of working with commercial or investment banking is desirableAbility to research, making use of the Internet and on-line systemsKnowledge of the regulatory environment is highly desirableExcellent written and verbal communication skillsDrive, Determination and Passion to succeedStrong Attention to detail & an analytical insightDetail oriented, with the ability to work independently and multi-task effectivelyFlexible to work in rotational 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

About The Role Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : SAP HCM Payroll Good to have skills : NAMinimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your typical day will involve collaborating with various teams to ensure that project goals are met, facilitating discussions to address challenges, and guiding your team through the development process. You will also be responsible for maintaining communication with stakeholders to provide updates and gather feedback, ensuring that the applications align with business needs and objectives. Your role will require a balance of technical expertise and leadership skills to drive successful project outcomes. Roles & Responsibilities:- Expected to be an SME.- Collaborate and manage the team to perform.- Responsible for team decisions.- Engage with multiple teams and contribute on key decisions.- Provide solutions to problems for their immediate team and across multiple teams.- Facilitate training and development opportunities for team members to enhance their skills.- Monitor project progress and implement necessary adjustments to meet deadlines. Professional & Technical Skills: - Must To Have Skills: Proficiency in SAP HCM Payroll.- Strong understanding of payroll processing and compliance regulations.- Experience with SAP HCM modules and integration with other systems.- Ability to analyze and troubleshoot payroll-related issues effectively.- Familiarity with data management and reporting tools within SAP. Additional Information:- The candidate should have minimum 5 years of experience in SAP HCM Payroll.- This position is based at our Bengaluru office.- A 15 years full time education is required. Qualification 15 years full time education

We are seeking a highly organized and detail-oriented Clinical Trial Coordinator (Fresher) to join our dynamic clinical research team. In this role, you will play a crucial part in ensuring the successful execution of our clinical trials from start to finish. You will collaborate with a multidisciplinary team of researchers, investigators, and study personnel to coordinate all aspects of clinical trial operations. Key Responsibilities: Study Coordination: Coordinate the day-to-day activities of assigned clinical trials, ensuring adherence to protocols, timelines, and regulatory requirements. Site Management: Assist in site selection, initiation, monitoring, and close-out activities. Documentation: Maintain accurate and complete study records, including case report forms, source documents, and regulatory binders. Communication: Facilitate effective communication between study sites, sponsors, investigators, and internal team members. Data Management: Ensure timely and accurate data collection, entry, and query resolution. Regulatory Compliance: Ensure compliance with all applicable regulations, guidelines, and standard operating procedures. Patient Recruitment: Support patient recruitment and retention efforts. Training: Provide training and support to study staff on study protocols and procedures. Quality Assurance: Participate in quality control activities and internal audits. Qualifications and Skills: Education: Bachelor's degree in life sciences, nursing, or a related field. Experience: Fresher or recent graduate with a strong interest in clinical research. Knowledge: Basic understanding of clinical research principles and Good Clinical Practice (GCP). Skills: Excellent organizational, communication, and interpersonal skills.

Job Title: Biostatistical Programmer (SDTM & ADaM) Experience: 5+ years Employment Type: Full-time Location: Hyderabad/Bangalore/Delhi/remote Industry: Pharmaceuticals / Clinical Research / CRO Functional Area: Biostatistics / Programming / Clinical Data Management About the Role We are seeking a skilled Biostatistical Programmer with 57 years of experience and strong expertise in CDISC standards (SDTM & ADaM) . This role involves developing, validating, and maintaining datasets and statistical outputs to support clinical trial submissions. You will work closely with biostatisticians, data managers, and clinical teams to ensure high-quality deliverables aligned with global regulatory requirements. Key Responsibilities Develop, validate, and maintain SDTM and ADaM datasets in compliance with CDISC standards and regulatory guidelines (FDA, PMDA, EMA). Program and validate tables, listings, and figures (TLFs) for clinical study reports and regulatory submissions. Ensure programming deliverables meet quality, timeline, and compliance standards. Collaborate with statisticians and clinical teams to translate analysis specifications into efficient programming solutions. Perform data quality checks and resolve issues in coordination with data management. Contribute to standardization efforts including macros, libraries, SOPs, and best practices. Support ad-hoc requests , exploratory analyses, and regulatory audits. Required Skills & Qualifications Bachelor’s/Master’s degree in Biostatistics, Computer Science, Life Sciences , or related field. Strong programming skills in SAS (Base SAS, SAS/STAT, SAS/Macro) , Python , and R . Hands-on experience with SDTM and ADaM dataset creation and validation . Solid understanding of CDISC standards and regulatory submission requirements. Knowledge of clinical trial processes , ICH-GCP guidelines , and statistical concepts. Strong problem-solving , attention to detail, and documentation skills. Experience with Cloud environments like AWS and Azure . Good to Have (Optional) Experience with Define.xml , Pinnacle 21 , and e-submission tools . Exposure to Life Sciences , Pharma/Clinical Research , or CRO settings . Familiarity with safety and efficacy analysis in clinical trials. How to Apply Interested candidates can apply directly through Naukri or send their updated resume to shyamala.gunde@excelra.com

Job Description Pharma Regulatory Affairs Manager Location: Pune, Maharashtra Department: Regulatory Affairs Reports To: Head – Regulatory Affairs / Senior Leadership Job Overview We are seeking a highly skilled and experienced Pharma Regulatory Affairs Manager to ensure compliance with global regulatory requirements and to support the successful development, approval, and commercialization of pharmaceutical products. The ideal candidate will bring deep expertise in regulatory affairs, strong leadership in navigating complex regulatory landscapes, and the ability to collaborate effectively with internal teams and regulatory authorities. Key Responsibilities Develop and implement regulatory strategies to ensure compliance with international and regional regulations . Prepare, review, and submit regulatory documents in line with global requirements (US, EU, and emerging markets). Liaise with regulatory authorities to address queries and obtain timely approvals. Monitor evolving regulatory guidelines and industry trends , assessing their impact on product development and commercialization. Partner with R&D, Quality, Clinical, and Legal teams to provide regulatory insights throughout the product lifecycle. Support documentation for clinical trials , including protocols, investigator brochures, and informed consent forms. Conduct risk assessments and provide recommendations for safety reporting and compliance obligations. Participate in audits and inspections , driving corrective and preventive actions as needed. Provide regulatory training and guidance to internal stakeholders to enhance compliance awareness. Qualifications & Requirements Education: Bachelor’s degree in Pharmacy or a related scientific field (Master’s preferred). Experience: 7 - 8 years in pharmaceutical regulatory affairs within a global organization. Strong knowledge of FDA regulations (21 CFR Part 11), ICH guidelines, EMA, and regional market requirements . Demonstrated success in regulatory submissions leading to product approvals. Proven project management skills , with the ability to manage multiple projects in a dynamic environment. Excellent written and verbal communication skills for engaging internal teams and external authorities. Strong analytical, problem-solving, and decision-making abilities. Proficiency in regulatory information management systems and related tools.

Regulatory affairs professional with experience in managing product listings for different markets and ensuring full compliance with all regulations. Proven track record of collaborating with renowned global cosmetic brands to navigate and meet regulatory requirements across multiple regions, including the USA, Canada, Australia, New Zealand and Middle East. Proficient in cosmetic regulations, including several regulations and versed with interpreting and applying recent regulatory updates. Highly skilled in managing compliance with state-specific regulations. Adept at leading cross-functional teams to support regulatory submissions and ensure product compliance, driving efficiency and market access. Ensure compliance with local and international cosmetic regulations, including ingredient restrictions, labeling, and claims. Ensure compliance with local and international cosmetic regulations, including ingredient restrictions, labeling, and claims. Stay updated with regulatory changes and proactively implement necessary product or process changes.

Role & responsibilities End-to-end project coordination for the assigned clients with effective client interface, communication, and time delivery of the projects. Ensuring work in compliance to SOPs, processes, and requirement of Management. Feasibility, proposal development, follow-up, and finalizing of the project contract for the BE projects for the assigned clients. Coordinate & facilitate sponsor visits during in-process and retrospective study monitoring. Act as a management designee in double-blinded studies if assigned. Coordination among internal team to ensure timely delivery of projects. Publishing a project schedule to the team with appropriate tracking of milestones. Facilitate inventory management of biological samples, investigational products, and documents to have proper track. Managing the CSR schedules and dispatch call. Managing and coordinating the clinical data entry team with the CDS team for CDISC datasets. Contributing to overall project objectives. Interpersonal relationship with the study team. Communicating the projects goals throughout the organization. BCSO calls for BA/BE centre capacity utilization. Coordinating IEC and IP/Plasma sample storage calls. Preferred candidate profile The candidate should have minimum 7+ years of experience in BA/BE Project management. Good in written and verbal communication. Good in presentation skills

1. Execute validation of analytical methods as per ICH guidelines 2. Method Verification 3. Method Transfer 4. Instrument Handling (HPLC,UV-Visible Spectrophotometer) 5. Documentation & Compliance 6. Audit Readiness & Regulatory Support Perks and benefits Bachelor's Accommodation and Travelling facility

Job Overview Provide medical safety expertise, directly and indirectly, to Sponsors of drugs, devices, and combination products, in the post marketing period. Summary Of Responsibilities Undertake primary medical review of cases, including medical assessment of the case for seriousness, listed/labeling, causality, adverse event coding and narrative review. Update and document daily case data, case-feedback in appropriate trackers/tools to facilitate tracking and workflow management. Assume complete responsibility for all assigned deliverables in line with expected quality, compliance, and productivity SLAs and KPIs. Provide training and guidance to the case processing team on medical aspects of case processing. Performs secondary medical review (QC role) and retrospective review of cases reviewed (QA role), as required for measuring quality of deliverables, identifying error trends, training needs and areas of improvement. Performs aggregate medical review and signal detection/analysis activities, as required. Enhances existing client relationships whenever possible. Creates, maintains, and assumes accountability for a culture of high customer service. Participates in process improvement activities across Company. And all other duties as needed or assigned. Qualifications (Minimum Required) Bachelors degree in medical science or MD or DO or equivalent degree. Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Language Skills: Speaking: English at ILR level 3+ or higher. Writing / Reading: English at ILR level 4+ or higher. Experience (Minimum Required) Working knowledge of medical sciences, diagnosis and therapeutics including drug treatments and procedures. Knowledge and understanding of regulatory requirements for Clinical Research. Knowledge and understanding of ICH-GCP guidelines. Preferred Qualifications Include Good understanding of regulatory requirements relating to Pharmacovigilance. Up to 2 years pharmaceutical industry experience, including pharmacovigilance (case processing, medical review) and/or clinical research. 1 to 2 years of clinicial practice experience. Physical Demands/Work Environment Office or home-based environment, as requested by the line manager. Learn more about our EEO & Accommodations request here. Show more Show less

Role & responsibilities Experience in operation and trouble shooting of process in plant. Isolation and purification of different organic compound using column chromatographic and crystallization techniques. Optimize the process parameters, what-if studies, holding studies etc. for scale up. Investigation of OOS/OOT and stability related issues. Handled various reagents like NaH, NaBH4, Br2, BHA, n-BuLi,TMSCl, TFA,PPA, Raney Nickel, Pd/carbon & also hazardous chemicals like POCl3, SOCl2 etc. Reactions performed like Hydrogenation,Brominaion,Oxidation,Reduction and condensation. Handling of Moisture sensitive reactions. Study and understand the project requirements, identifying and collection of suitable literature. Support lab manager to prepare weekly technical reports and other project related technical documents (impurity profile tables,Plant batch data,developmental reports) Executing assigned reactions of project. • Looking after the Safety equipments management and maintaining it as per regulatory requirement in R&D lab. • Study the MSDS of each chemical using in every new project and make arrangement of Safety equipments accordingly. Handled HPLC system of Agilent technologies Ezichrome (A.04.07) and version Open Lab cds2.4 • Good in Thin layer chromatography & Column chromatography. Preferred candidate profile Perks and benefits

Roles and Responsibilities Develop new APIs through organic synthesis, method development, and optimization. Conduct literature reviews to stay updated on latest research trends and technologies. Ensure compliance with GMP guidelines during API manufacturing processes. Collaborate with cross-functional teams for product development, scale-up, and commercialization. Perform impurity analysis using techniques like NMR, DSC, etc. Desired Candidate Profile MS/M.Sc(Science) degree in Chemistry or Ph.D/Doctorate in Chemical Sciences from a recognized university. Strong expertise in areas such as API synthesis, organic chemistry, method development/validation/transfer/methodology. 9-14 years of experience in Research & Development (R&D) or related field. Key Responsibilities Literature Review & Route Identification Perform comprehensive literature and patent searches (SciFinder, Reaxys, PubChem, etc.). Identify and evaluate synthetic routes for APIs, intermediates, and impurities. Synthetic Research & Development Plan and perform multi-step organic synthesis experiments. Develop and optimize cost-effective and robust synthetic processes. Work on impurity profiling and synthesis of known/unknown impurities (including nitrosamines/nitroamines). Process Optimization & Scale-Up Support Optimize reaction parameters for higher yield, purity, and reproducibility. Support process development, kilo-lab trials, and technology transfer. Address scale-up challenges in collaboration with process R&D teams. Analytical Collaboration Interpret analytical data (HPLC, LC-MS, NMR, IR) for structure confirmation. Work with Analytical R&D to characterize intermediates, APIs, and impurities. Documentation & Compliance Maintain accurate lab notebooks, experiment records, and reports. Prepare technical documents for DMFs, ANDAs, and regulatory submissions. Ensure GLP, GMP, EHS, and data integrity compliance. Teamwork & Leadership (For Sr. Executive Level) Independently lead assigned projects with minimal supervision. Mentor and guide junior chemists/trainees in lab activities. Provide technical support for regulatory/customer queries.

About The Role Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Associate Qualifications: BE/BTech 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.The Clinical Database Management team is committed to developing and maintaining databases for clinical trials, which includes creating Case Report Forms (CRFs) and developing Edit and Validation Checks using programming skills like C# and PL/SQL. They also support data integration from various external sources such as labs and Interactive Response Technology (IRT). The team ensures compliance with regulatory standards and guidelines, maintaining high levels of data quality and security. Additionally, they continuously seek to improve database processes and tools by leveraging the latest technologies and best practices to enhance efficiency and accuracyDevelop clinical study databases by building electronic case report forms and program edit checks as per specifications. Support any updates or changes to the study database (e.g. Protocol amendments) through the change control process. What are we looking for Clinical Database ProgrammingClinical Data ManagementSAS ClinicalAdaptable and flexibleAbility to perform under pressureProblem-solving skillsAbility to establish strong client relationshipAgility for quick learningOracle Procedural Language Extensions to SQL (PLSQL)Structured Query Language (SQL)C, C++, C# Programming SkillsExperience in writing programs using Javascript 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 BE,BTech

About The Role Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Associate Qualifications: BE/BTech 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.The Clinical Database Management team is committed to developing and maintaining databases for clinical trials, which includes creating Case Report Forms (CRFs) and developing Edit and Validation Checks using programming skills like C# and PL/SQL. They also support data integration from various external sources such as labs and Interactive Response Technology (IRT). The team ensures compliance with regulatory standards and guidelines, maintaining high levels of data quality and security. Additionally, they continuously seek to improve database processes and tools by leveraging the latest technologies and best practices to enhance efficiency and accuracyDevelop clinical study databases by building electronic case report forms and program edit checks as per specifications. Support any updates or changes to the study database (e.g. Protocol amendments) through the change control process. What are we looking for Clinical Database ProgrammingClinical Data ManagementSAS ClinicalAdaptable and flexibleAbility to perform under pressureProblem-solving skillsAbility to establish strong client relationshipAgility for quick learningOracle Procedural Language Extensions to SQL (PLSQL)Structured Query Language (SQL)C, C++, C# Programming SkillsExperience in writing programs using Javascript 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 BE,BTech

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

About The Role Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years What would you do? Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model powered by data, intelligent technologies and talentLooking for someone with AML and Fraud mgmt experience.Understand & implement laws, and regulations designed to stop the practice of generating income through illegal actions during transfer of funds. Anti Money Laundering law covers limited number of transactions and criminal behaviors to prevent terrorist financing and money laundering and compliance programs, including know-your-customer (KYC) rules. Strong coping, emotional resilience, and stress-management skills Excellent comprehension and communication Ability to perform duties objectively, devoid of inherent biases or personal beliefs, in the best interest of client policies Strong attention to detail Comfort synthesizing and analyzing information from multiple streams Strong critical thinking and decision-making skillsLooking 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. 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? Ability to work well in a teamIn 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 This includes driving customer identification, customer due diligence & enhanced due diligence. 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. 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 Any Graduation

About The Role Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years What would you do? Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model powered by data, intelligent technologies and talentLooking for someone with AML and Fraud mgmt experience.Understand & implement laws, and regulations designed to stop the practice of generating income through illegal actions during transfer of funds. Anti Money Laundering law covers limited number of transactions and criminal behaviors to prevent terrorist financing and money laundering and compliance programs, including know-your-customer (KYC) rules. Strong coping, emotional resilience, and stress-management skills Excellent comprehension and communication Ability to perform duties objectively, devoid of inherent biases or personal beliefs, in the best interest of client policies Strong attention to detail Comfort synthesizing and analyzing information from multiple streams Strong critical thinking and decision-making skillsLooking 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. 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? Ability to work well in a teamIn 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 This includes driving customer identification, customer due diligence & enhanced due diligence. 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. 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

Maintaining Quality Systems Ensuring cGMP compliance Prepare Batch Manufacturing Records Process Validation and Cleaning Validation Dossier Preparation and New Drug Applications Document Quality Risk activities Required Candidate profile Experience in GMP, ICH Q series and pharmaceutical quality systems Strong in documentation, audit preparedness and regulatory compliance

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: Bachelor of Pharmacy/Bachelor of Physiotheraphy/BSc. Nursing Years of Experience: 0 to 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 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 Adaptable and flexibleAgility for quick learningAbility to work well in a team 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,Bachelor of Physiotheraphy,BSc. Nursing