241 Ich Jobs - Page 2

Job Description: Active involvement in CAPA management activities within the team. Preferably must have faced Internal /Client audit. Working knowledge of the global pharmaceutical/pharmacovigilance regulations (ICH/ Good Pharmacovigilance modules) is preferable. Knowledge of TrackWise shall be an added advantage. Interpersonal and professional skills to interact at all levels including senior executives, contractors, and colleagues. Contribute to Global PV CAPA & Deviation Management implementation and documentation by completing all required processes as assigned. Audit & Inspection CAPA Management: 1. Collaborate with company departments/teams internal and external to provide oversight and ensure proper development of CAPAs from internal quality audits and support regulatory inspections, as assigned by respective stakeholders. 2. Support the Company Main Contact (CMC) responsible for the development of responses to Audit, Regulatory Inspection or Process Deviation observations. 3. Set up and coordinate the required meetings on behalf of the CMC in order to expedite the CAPA preparation and closure process. 4. Perform the role of Assigned to Finding Owner within the eQCMS in order to support the CMC and Assigned to CAPA Owner. 5. Ensure timely and effective closure of assigned Global PV CAPAs in collaboration with the CMC, Finding and CAPA Owners. 6. Contribute to Global PV CAPA Management implementation and documentation by completing all required processes - Obtain evidence of CAPA completion. Track and monitor CAPAs with assigned stakeholders. Ensure CAPA effectiveness checks, where applicable. Deviation Management: Support the Department Manager/ Designee in planning, executing and managing deviation and its associated CAPAs through eQCMS; monitor due dates and related extensions. Set up & coordinate the required meetings with concerned Otsuka stakeholders in order to expedite creation of Deviation & its related CAPAs. Collaborate with Department Manager/Designee regarding deviation related activities, including eQCMS access. Coordinate and manage effective entry/ follow ups of PV related deviations. Support the Department manager/ Designee in reviewing the deviations and its related CAPAs. Perform the role of Originator &/or Assigned To within eQCMS. Ensure timely & effective closure of deviations & its associated CAPAs. Contribute to Global PV Deviations Management implementation and documentation by completing all required processes - Obtain evidence for Deviation completion. Track and monitor Deviations and its associated CAPAs with assigned stakeholders. Ensure CAPA effectiveness checks, where applicable. Utilize company systems as provided access/training to, including but not limited to, the following: eQCMS (i.e. TrackWise etc.) SOP system(s) SharePoint Communications (e.g. Outlook, Teams).

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

Role & responsibilities - Preparing Dossiers for registration of products in various ROW markets - Knowledge of CTD format is mandatory Preferred profile Qualification: B. Pharm and M. Pharm Experience: 2 years Salary: 20,000 to 40,000 per month Health insurance Accidental insurance Annual bonus

: Established in 1991, Matrix (www.matrixcomsec.com) is a leader in Security and Telecom solutions for modern businesses and enterprises. Matrix has launched cutting-edge products like Video Surveillance Systems - Video Management Software, Network Video Recorder, and IP Camera, Access Control and Time-Attendance Systems as well as Telecom Solutions such as Unified Communications, IP-PBX, Universal Gateways, VoIP and GSM Gateways, and Communication Endpoints. These solutions are feature-rich, reliable, and conform to international standards. Having global footprints in Asia, Europe, North America, South America, and Africa through an extensive network of more than 2,500 channel partners, Matrix ensures that the products serve the needs of its customers faster and longer. We aspire to be the world leader in innovative telecom and security solutions by offering cutting-edge, high-performance telecom and security solutions to business customers. Roles and Responsibilities : Maintain client relations to build excellent reputation for service and produce repeat business. Interact regularly with top ten accounts related to weekly selling, deliveries and stock availability. Maintaining contact with existing clients to ensure that they are satisfied with their services Building relationships with existing clients to ensure repeat business and new business opportunities Managing existing customer accounts by ensuring that existing customers remain satisfied with company products and services. Developing and implementing effective account plans to retain existing customers. Identifying customer needs and communicating how company products and services fulfill those needs. Suggesting innovative ways to increase sales and enhance clients' experience. KRA's: Sales from regular SI's Number of SI's build How to get constant business from SI's Skills Required: Ability to increase customer engagement. Knowledge of customer relations management software and MS Office. Outstanding communication and negotiation skills. Analytical and time management skills.

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

Job Description Candidate should the exposure for handling the Bottle packing line. Should have the work experience in Regulatory plant. Faced the USFDA, MHRA,TGA inspection. Good Communication skill. Having the SAP knowledge. Work Experience 3 to 05 years' Experience. Education Graduation in Pharmacy Competencies

Analysts engage in risk, compliance, and financial crimes projects to serve Promontory clients within the banking and finance industry – helping them meet and exceed regulatory expectations. Analysts are expected to positively contribute to Promontory’s success in a variety of areas, including BSA, anti-money laundering surveillance and reporting assistance, OFAC sanctions compliance, and other areas relevant to today’s heightened regulatory climate. Analysts must possess excellent writing, research, analytical, and critical thinking skills, and other applicable experience that leads to success in the role, such as strong work ethic and natural curiosity. Analysts must be able to judiciously analyze, assess, and write clearly and concisely. The nature of this work requires individuals to be flexible, learn new skills, work within time constraints, and meet uncompromising quality requirements and production expectations while working closely with others in a dynamic team environment. Apply logic and strong reasoning skills to conduct research for case analysis. Use sound decision-making skills to make recommendations based on research results. Compose comprehensive supporting narratives Interpret and apply project policies and procedures to direct work. Maintain high work product quality as outlined by each project specifications. Ensure work adheres to defined engagement policies and procedures Manage work efficiently to meet production goals and project deliverables. Contribute to developing individual and project goals and execute on tactical strategies for goal attainment. Required education Bachelor's Degree Preferred education Master's Degree Required technical and professional expertise 1+ year prior AML experience REQUIRED. Compliance experience at a financial institution is STRONGLY PREFERRED. Retail banking experience is PREFERRED. The ability to work independently, take initiative, and able to adapt to change. Ability to quickly understand and maintain current know3ledge of banking regulations, concepts, and issues. Quickly learn new applications and client systems to conduct research. Exercise sound judgment and observe the highest degree of confidentiality. Adept at multi-tasking and meeting deadlines in high-pressure environment. Results oriented team player with strong initiative and flexibility. Strong analytical and problem-solving abilities. Superior writing skills with the ability to convey ideas clearly and succinctly. Exemplary customer service towards both internal and external parties.

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

Characterization of marketed product wrt market requirements Knowledge of ICH stability conditions and compilation of analytical data Preparation of documents like PDR, stability protocol, development report writing FDR/PDR Required Candidate profile Candidate should perform literature search Looking candidates for PDR (Formulation & Development ) Dept. Candidate should have experience in solid oral dosage (Regulated Market- USA/EU/ South Africa)

Study Start Up Specialist POSITION PURPOSE: Study Start Up Specialist is responsible for country study start up (SSU) activities and performing quality review of essential documents. The SSU Specialist is responsible for overseeing and leading SSU activities in collaboration with country team members (CLM and CRA) with the objective to improve site activation and maximize patient recruitment time. The SSU Specialist is responsible for the start-up of clinical trial activities in their assigned country/countries to achieve greenlight for selected sites. Specialist also performs quality review of essential documents at start up and during the lifecycle of the study, ensuring adherence to ICH-GCP guidelines, local requirements and Bayer QSDs. ROLE AND RESPONSIBILITIES: Interact with site and study personnel to collect country specific documents such as IRB/IEC approvals, financial disclosure, CVs/medical licenses, etc. and review for accuracy, completeness and adherence to ICH/GCP and Bayer QSDs Perform quality review of country and site level essential documents following a risk-based approach, issue queries, and communicate outcome to identified users at key milestones and during the course of the study Prepare and submit regulatory and IRB/IEC documentation as required per country requirements and Bayer QSDs during the course of the study Preparation, tracking, and distribution of site start up documentation including Investigator Site File Obtain any required approvals for relevant site document (e.g. informed consent, financial disclosures) to ensure start up timelines are met Manage oversight, in collaboration with CLM, of country and site start up activities and eTMF quality using Vault Clinical reports and dashboards Monitor internal start up KPIs across studies and identify and communicate trends Support start up process improvement implementation In collaboration with CRA, maintain and ensure accuracy of site information in Vault Assist with audits/inspections of relevant start up activities and/or eTMF Attend and actively participate in team meetings by providing site greenlight projections and timelines Provide input on site activation strategy Ensure awareness of related local regulations and support maintenance of country intelligence in Veeva WHO YOU ARE: The incumbent should have a Bachelor s degree (or equivalent experience) and minimum of 2 years of experience in clinical development including start up/ regulatory process experience Understanding of ICH-GCP essential documentation and familiarity with country specific clinical trial regulations Demonstrated ability to quality review documents and identify discrepancies/inconsistencies preferred Ability to embrace Veeva Clinical Vault system and associated functionality Strong written and verbal English communication skills Flexibility to adapt to changing business needs and priorities Demonstrated organization skills and attention to detail Strong service orientation Ability to work independently and manage multiple tasks and priorities Ever feel burnt out by bureaucracy? Us too. That s why we re changing the way we work for higher productivity, faster innovation, and better results. We call it Dynamic Shared Ownership (DSO). Learn more about what DSO will mean for you in your new role here Bayer does not charge any fees whatsoever for recruitment process. Please do not entertain such demand for payment by any individuals / entities in connection with recruitment with any Bayer Group entity(ies) worldwide under any pretext. Please don t rely upon any unsolicited email from email addresses not ending with domain name bayer.com or job advertisements referring you to an email address that does not end with bayer.com . Bayer is an equal opportunity employer that strongly values fairness and respect at work. We welcome applications from all individuals, regardless of race, religion, gender, age, physical characteristics, disability, sexual orientation etc.

*Greetings From You & I Consulting ! You & I Consulting has always been in the spotlight for getting placed in 64+ MNC's PAN India. *Hurry Do Not Miss This Opportunity To Work For Global Giant MNC. We are hiring for the below locations under Medical Reviewer Role!! *Open Locations :- * Pune/ / Chennai / Mumbai *Mode Of Interview - Virtual *Mode Of Work :- Work From Office * CTC Upto - 10 To 24Lpa *Call Now our HR Specialist:- @ puja - 8250242229 (call or whts app) or email your CV to puja@careersuni.com PFB Job Insights for Medical Reviewer Role!! Author a CCC for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: Review and respond to any queries/comments from the Case Owner, which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database. Detail any requests for changes to the case, including the narrative. Skills required:- Computer Literate (good knowledge of MS Office) Sound understanding of the Drug Safety and Regulatory process Good problem solving and decision-making skills Capability to lead by motivation and example Ability to prioritize schedule and organize Excellent interpersonal and communication skills * * *Call Now our HR Specialist:- @ puja - 8250242229 (call or whts app) email your CV to puja@careersuni.com ***Note we also have open positions for the below skills :- * * *Call Now our HR Specialist for more details:- @ puja - 8250242229 (call or whts app) email your CV to puja@careersuni.com *Aggregate Reporting / Clinical Data Management / Clinical SAS / SQL Programmer / EDC Programmer / Medical Monitor / HEOR Health Economist Role / SAS + R / Statistical Programmer / Study Data Manager *Though We Try and Answer The Calls Immediately, but Due to Heavy Call Flow The Below Numbers Might Be Busy At Times. In case you find the number busy, please whatsapp your details to us in the below format: - Name- Mobile number - Mail - Qualification - Total work experience - Current Organization- Location - Last CTC Expected CTC:- *Interested candidates can even refer their friends or relatives provided the criteria *FOR interview Call Now our HR Specialist:- @ puja - 8250242229 (call or whts app) email your CV to puja@careersuni.com

Role & responsibilities Regulatory Strategies & Submissions: Develop & implement regulatory strategies for new/generic product registrations in compliance with relevant regulations and the business needs. Preparing and submitting regulatory documents like Drug Master Files (DMFs) and marketing authorization applications (MAAs) to regulatory bodies. Preparation and Compilation of dossiers in CTD & eCTD. Collaborating with cross-functional teams to address regulatory queries in a timely manner. Responsible for end-to-end filing of New products (Actives / Fixed Dose Combinations / Nutritional supplements etc.) in CDSCO (Central Drugs Standard Control Organization), FSSAI, State FDA and other regulatory bodies. Filing application of ND/SND/FDC/Import Registration/Import license etc. on SUGAM portal. Track and interpret evolving regulatory requirements and assess their impact on ongoing projects. Collaborate with marketing and business development to support go-to-market strategies, portfolio expansion. Compliance & Change Control: Ensuring that manufacturing processes meet all relevant regulations and guidelines. Assessing and managing the regulatory impact of changes to manufacturing processes. Review of technical documents, Change controls Gap analysis for variation filing and maintaining product Life cycle. Collaborating with cross-functional teams, such as R&D, QA, and manufacturing, to ensure regulatory compliance. Audits and Inspections: Preparing for and supporting regulatory audits and inspections across various contract manufacturing sites. Ensuring that corrective actions are implemented in a timely manner with respect to Audit findings and that any necessary documentation is updated in a systematic manner. Others: Staying up-to-date with current FDA / FSAAI regulatory requirements and guidelines for APIs and Finished formulations. Provide regulatory support to QA-AC for IPC/CDTL/CDL testing Providing regulatory support for new product development. Key Result Areas: Manage proactive and professional delivery of results for the regulatory activities of all the products to support the business goals Ensure a high scientific standard and quality for all regulatory documents Monitoring and ensuring that both API manufacturing and Finished formulations production adhere to all applicable regulations. Preferred candidate profile B-Pharma or M-Pharma Minimum of 8 to10 years of experience in regulatory affairs in pharmaceutical industry, With at least 3 to 4 years in a managerial role. Strong understanding of pharma regulatory framework. Excellent communication and multi-tasking skills Location Mumbai HO / Regular visits to various Contract Manufacturing sites Department Regulatory Affairs

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: Provider Network - Life Sciences Regulatory Operations Designation: Health Operations 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 Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsCoordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for Any graduate with some Health care experienceAny graduate with some Health care experience 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

Watson Pharma Private Limited. is looking for Medical Writing Associate to join our dynamic team and embark on a rewarding career journey Processing requisition and other business forms, checking account balances, and approving purchases. Advising other departments on best practices related to fiscal procedures. Managing account records, issuing invoices, and handling payments. Collaborating with internal departments to reconcile any accounting discrepancies. Analyzing financial data and assisting with audits, reviews, and tax preparations. Updating financial spreadsheets and reports with the latest available data. Preparation of operating budgets, financial statements, and reports. Reviewing existing financial policies and procedures to ensure regulatory compliance. Providing assistance with payroll administration. Keeping records and documenting financial processe

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years About Accenture 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 incumbent will perform the regulatory operations tasks of bookmarking and hyper linking for granular components (documents) of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components.Collect, collate and evaluate the scientific data gathered as part of R & D. Advise on legal and scientific restraints and requirements. Ensure the organization`s products comply with current regulations. Example; Build regulatory submission strategy, author CMC documents, and health authority packages etc. What are we looking for Ability to meet deadlinesAbility to perform under pressureAbility to work well in a teamAdaptable and flexibleAgility for quick learning Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Master 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

Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Specialist Qualifications: BE 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.Develop and review complex edit checks, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. What are we looking for Generative AI, LLM (Large Language Model), Python skills along with OOPS concept. Understands framework and have understanding on agentic AI building. 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

Need to have good understanding of the D & C Act, CDSCO Guidance for Industry, ICH Regulations and NDPS Acts. - Strategize, submit and Obtain approvals from CDSCO i.e. FORM 11, CT 17, CT 04, CT 21, CT 18, Form 10, MD 5, MD 6, MD 17, MD 15, Dual NOC in timely manner. - Strategize, submit and obtain approvals from State FDA i.e. Test license, Manufacturing license, Export/Domestic License, COPP, FSC, Loan License, WHO GMP, State GMP/GLP. - Strategize, submit and obtain approvals from CBN i.e. Export Authorizations and Import Authorizations. - Additionally, must have knowledge about FSSAI registration and licenses. - Ensure that regulatory strategies are implemented, timely review and alignment with CFTs including R & D, Quality Unit, Manufacturing, Supply Chain, Marketing team -Work Closely with R & D, Quality Unit, Manufacturing, Supply Chain & Logistics in providing regulatory inputs during product development to clearly communicate the regulatory requirements for securing the necessary licenses/approvals in India and for global submissions. - Well versed about the Online portal i.e. Sugam, NSWS, IDML, IFP, Unified CBN and FOSCOS portal. - He/She should be able to handle the queries raised by the aforesaid government department. -Need to possess good communication.

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 : OneTrust Privacy Management 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. You will be responsible for overseeing the application development process and ensuring successful project delivery. 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- Lead the application development process- Ensure timely project delivery- Provide guidance and mentorship to team members Professional & Technical Skills: - Must To Have Skills: Proficiency in OneTrust Privacy Management- Strong understanding of data privacy regulations- Experience in implementing privacy management solutions- Knowledge of data protection laws and compliance requirements- Hands-on experience in configuring privacy management tools Additional Information:- The candidate should have a minimum of 5 years of experience in OneTrust Privacy Management- This position is based at our Bengaluru office- A 15 years full-time education is required Qualification 15 years full time education

Stedman Pharmaceuticals is looking for a dynamic and experienced candidate for the Quality Control (QC) department with hands-on experience in Analytical Method Validation for various dosage forms. Resume to hrd@stedmanpharma.com / 9786920463

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

Job Area: Finance & Accounting Group, Finance & Accounting Group > Global Accounting Ops Center General Summary: Job Overview The EMEA Payroll Staff will support the Qualcomm EMEA Payroll function, its processes, and internal or external relationships with General Accounting, Human Resources, Legal, Benefits, Employee Relations, Stock Programs, IT, Tax Auditors, ADP, and other related entities. This position will be responsible for developing, implementing, and maintaining processes that will contribute to efficient payroll processing for 5,000+ employees across multiple EMEA countries. This position will report to the Payroll Manager, located in Hyderabad, and will be responsible for coaching and guiding junior team members. The ideal candidate for this position is a people manager with 12+ years of experience, including a minimum of 3+ years in people management. We are looking for an individual with demonstrated experience in multi-country accurate and timely payroll processes who can effectively communicate with a global team. Responsibilities Own the operations of EMEA payroll for countries such as the UK, Ireland, France, Sweden, Netherlands, etc. This may include directly managing the EMEA payroll teams processing of monthly payroll, including ESPP and RSU stock reporting, benefits, tax, and social insurance requirements and reporting Timely review and first approval of multiple monthly payrolls for the accuracy, completeness and compliance Ensure compliance in operational controls around critical payroll processes such as new hires, terminations, and one-time payments Collaborate closely with the global payroll team and payroll partners on payroll processing, department initiatives, and projects Analyze payroll processes and controls, identify opportunities for improvement, and ensure global process consistency where applicable Liaise with external auditors and manage payroll-related audits Perform other special projects and analyses as directed by management Keep an eye on payroll KPIs and lead from front to improve them Minimum Qualifications Bachelors degree or equivalent foundation degree Certified Payroll Professional certification- good to have 10-12 years of total EMEA country payroll experience Demonstrable experience of mentoring junior team members Experience working in a multinational organization Expert skills with ADP Global View and Workday Excellent understanding of payroll systems, data workflows, and root cause analysis Current knowledge of applicable tax, social security, and other compliance requirements across multiple EMEA countries Fluent in spoken and written English Knowledge of taxable and non-taxable earnings and expenses; payroll tax laws and complex employee benefit programs impacting payroll Proven experience in designing and implementing processes, controls, and systems Solid understanding of equity-related transactions (RSU, ESPP gain) Ability to handle multiple tasks, set priorities, and meet deadlines in a high-volume, fast-paced environment High degree of accuracy, attention to detail & strong Excel and numerical skills Strong knowledge of payroll accounting and reconciliations Outstanding written and oral communication, organizational, and leadership skills Preferred Qualifications Masters degree in accounting Proficiency in French or any other European language Hands-on payroll knowledge of France, Sweden, and UK payrolls Any payroll certification is a plus End-to-end project experience with ADP Global View implementation Exposure or experience in mergers and acquisitions Minimum Qualifications: Bachelor's degree. 6+ years of Finance, Accounting, or related work experience.*Completed advanced degrees in a relevant field may be substituted for up to two years (Masters = one year, Doctorate = two years) of work experience. Job Overview The EMEA Payroll Staff will support the Qualcomm EMEA Payroll function, its processes, and internal or external relationships with General Accounting, Human Resources, Legal, Benefits, Employee Relations, Stock Programs, IT, Tax Auditors, ADP, and other related entities. This position will be responsible for developing, implementing, and maintaining processes that will contribute to efficient payroll processing for 5,000+ employees across multiple EMEA countries. This position will report to the Payroll Manager, located in Hyderabad, and will be responsible for coaching and guiding junior team members. The ideal candidate for this position is a people manager with 12+ years of experience, including a minimum of 3+ years in people management. We are looking for an individual with demonstrated experience in multi-country accurate and timely payroll processes who can effectively communicate with a global team. Responsibilities Own the operations of EMEA payroll for countries such as the UK, Ireland, France, Sweden, Netherlands, etc. This may include directly managing the EMEA payroll teams processing of monthly payroll, including ESPP and RSU stock reporting, benefits, tax, and social insurance requirements and reporting Timely review and first approval of multiple monthly payrolls for the accuracy, completeness and compliance Ensure compliance in operational controls around critical payroll processes such as new hires, terminations, and one-time payments Collaborate closely with the global payroll team and payroll partners on payroll processing, department initiatives, and projects Analyze payroll processes and controls, identify opportunities for improvement, and ensure global process consistency where applicable Liaise with external auditors and manage payroll-related audits Perform other special projects and analyses as directed by management Keep an eye on payroll KPIs and lead from front to improve them Minimum Qualifications Bachelors degree or equivalent foundation degree Certified Payroll Professional certification- good to have 10-12 years of total EMEA country payroll experience Demonstrable experience of mentoring junior team members Experience working in a multinational organization Expert skills with ADP Global View and Workday Excellent understanding of payroll systems, data workflows, and root cause analysis Current knowledge of applicable tax, social security, and other compliance requirements across multiple EMEA countries Fluent in spoken and written English Knowledge of taxable and non-taxable earnings and expenses; payroll tax laws and complex employee benefit programs impacting payroll Proven experience in designing and implementing processes, controls, and systems Solid understanding of equity-related transactions (RSU, ESPP gain) Ability to handle multiple tasks, set priorities, and meet deadlines in a high-volume, fast-paced environment High degree of accuracy, attention to detail & strong Excel and numerical skills Strong knowledge of payroll accounting and reconciliations Outstanding written and oral communication, organizational, and leadership skills Preferred Qualifications Masters degree in accounting Proficiency in French or any other European language Hands-on payroll knowledge of France, Sweden, and UK payrolls Any payroll certification is a plus End-to-end project experience with ADP Global View implementation Exposure or experience in mergers and acquisitions Applicants Qualcomm is an equal opportunity employer. If you are an individual with a disability and need an accommodation during the application/hiring process, rest assured that Qualcomm is committed to providing an accessible process. You may e-mail or call Qualcomm's toll-free number found . Qualcomm expects its employees to abide by all applicable policies and procedures, including but not limited to security and other requirements regarding protection of Company confidential information and other confidential and/or proprietary information, to the extent those requirements are permissible under applicable law. To all Staffing and Recruiting Agencies Please do not forward resumes to our jobs alias, Qualcomm employees or any other company location. Qualcomm is not responsible for any fees related to unsolicited resumes/applications. If you would like more information about this role, please contact .