328 Case Processing Jobs - Page 4

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Delivery Lead Manager Qualifications: MD Years of Experience: 13 to 18 years 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? In this role you are required to identify and assess complex problems for area of responsibility The person would create solutions in situations in which analysis requires an in-depth evaluation of variable factors Requires adherence to strategic direction set by senior management when establishing near-term goals Interaction of the individual is with senior management at a client and/or within Accenture, involving matters that may require acceptance of an alternate approach Some latitude in decision-making in involved you will act independently to determine methods and procedures on new assignments Decisions individual at this role makes have a major day to day impact on area of responsibility The person manages large - medium sized 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 Roles and Responsibilities: In this role you are required to identify and assess complex problems for area of responsibility The person would create solutions in situations in which analysis requires an in-depth evaluation of variable factors Requires adherence to strategic direction set by senior management when establishing near-term goals Interaction of the individual is with senior management at a client and/or within Accenture, involving matters that may require acceptance of an alternate approach Some latitude in decision-making in involved you will act independently to determine methods and procedures on new assignments Decisions individual at this role makes have a major day to day impact on area of responsibility The person manages large - medium sized 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 MD

Skill required: Clinical Data Services - Clinical Data Management Designation: Clinical Data Svs Associate Qualifications: BTech/Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years 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. A critical phase in clinical research that assures collection, integration and availability of data at appropriate quality and cost. It also supports the conduct, management and analysis of studies across the spectrum of clinical research as defined by the National Institutes of Health (NIH). What are we looking for? Adaptable and flexible Problem-solving skills Detail orientation Ability to establish strong client relationship Agility for quick learning Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification BTech,Bachelor of Pharmacy,Master of Pharmacy

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Performing triage and review for initial validity assessment of cases including spontaneous, health authority, Clinical Trial and literature cases. Responsible for quality management, workload management, compliance management and document management for the assigned PV projects Evaluation of the need for expedited reporting to Health Authorities / partners of a client concerned, including reporting timelines Preparation of standard reporting forms (e.g., CIOMS I / MedWatch Forms and XML files) Preparation and sending of follow?up requests Submission of ICSRs to Health Authorities and partners of a client Acts as line manager of assigned staff Manages project coordination and resource allocation within the projects Train and mentor PV department staff, as needed Ensures monthly invoices are generated and shared for all PV clients on regular/monthly basis Responsible for recruitment of new staff in PV Department Ensures all departmental CVs, job descriptions and training records are complete and up to date and as per SOPs Is involved in goal setting and annual appraisals of staff Participate in the goal-setting process and conduct annual appraisals for staff, providing constructive feedback and support to foster individual development and align team objectives with organizational goals. Ensures training compliance by PV staff at all times Represents PV department during for-cause/maintenance client audits or regulatory authority inspections Ensure compliance with internal standards and external (national and international) regulations To write/ review QA documents such as SDEAs, Working Instructions, SOPs, Working Procedures, templates, project metafiles etc. for PharmaLex Pharmacovigilance projects To organize and perform training of the above-mentioned documents Case processing including data entry and QC Case completion / documentation. Actively mentor and support new joiners by providing guidance on company processes, facilitating their integration into the team, and fostering a collaborative learning environment to enhance their professional development. Responsibilities will be assigned by the supervisor in accordance with process requirements. Performing triage and review for initial validity assessment of cases including spontaneous, health authority, Clinical Trial and literature cases. Responsible for quality management, workload management, compliance management and document management for the assigned PV projects Evaluation of the need for expedited reporting to Health Authorities / partners of a client concerned, including reporting timelines Preparation of standard reporting forms (e.g., CIOMS I / MedWatch Forms and XML files) Preparation and sending of follow?up requests Submission of ICSRs to Health Authorities and partners of a client Acts as line manager of assigned staff Manages project coordination and resource allocation within the projects Train and mentor PV department staff, as needed Ensures monthly invoices are generated and shared for all PV clients on regular/monthly basis Responsible for recruitment of new staff in PV Department Ensures all departmental CVs, job descriptions and training records are complete and up to date and as per SOPs Is involved in goal setting and annual appraisals of staff Participate in the goal-setting process and conduct annual appraisals for staff, providing constructive feedback and support to foster individual development and align team objectives with organizational goals. Ensures training compliance by PV staff at all times Represents PV department during for-cause/maintenance client audits or regulatory authority inspections Ensure compliance with internal standards and external (national and international) regulations To write/ review QA documents such as SDEAs, Working Instructions, SOPs, Working Procedures, templates, project metafiles etc. for PharmaLex Pharmacovigilance projects To organize and perform training of the above-mentioned documents Case processing including data entry and QC Case completion / documentation. Actively mentor and support new joiners by providing guidance on company processes, facilitating their integration into the team, and fostering a collaborative learning environment to enhance their professional development. Responsibilities will be assigned by the supervisor in accordance with process requirements. What Cencora offers Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements. Full time Affiliated Companies Affiliated Companies: PharmaLex India Private Limited Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The companys continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email [HIDDEN TEXT]. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned Show more Show less

JD: Title: Safety & Pharmacovigilance-I Location: Hybrid-Gurugram Experience: 1-4 yrs Skillset: 1)Experience in ICSR case processing. Spontaneous / CT/ Literature case processing experience will also be considered. Good understanding on Medical Knowledge / Terminology . 2)Databases/Tool: Argus /Aris-G / LSMV 3)Good communication. Interested one kindly apply thorugh below link. https://www.syneoshealth.com/careers/jobs/16631872-safety-and-pv-specialist-i or Navigate to Syneos Careers: Job ID: 25100771 Regards, Naveen.R

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

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

Skill required: Pharmacovigilance Services - Safety Writing Designation: Pharmacovigilance Services Sr Analyst Qualifications: Bachelor of Pharmacy Years of Experience: 5 to 8 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. What are we looking for Ability to establish strong client relationship Roles and Responsibilities: oPrepare and review Aggregate reports and any adhoc reports requested by Client.oConduct or attend and contribute, as applicable, to a kick-off meeting and regular teleconferences with the Client during the preparation of Aggregate reports.oComplete all the sections of Aggregate Reports as per Client SOPs and guidelines and as agreed during kick-off meeting.oLiaise with relevant internal and Client stakeholders for the inputs required for the Aggregate Reports.oCoordinate data cleaning process (missing data clearance and send request for stop/ resume book in of cases) prior to final listings generation.oPerform activities as lead author and prepare submission ready draft for Aggregate reports.oPerform QC of the assigned draft Aggregate reports, per scorecard agreed with Client, and provide feedback to the responsible author with the duly filled scorecard defect tracker.oReview source documentation provided by Client for completeness and accuracy.oFacilitate stakeholders review as defined by the Client.oShall address all the comments received from all the stakeholders including review comments and provide the respective final versions of the reports to the Client ready for publishing.oOn-time escalation of any delayed inputs. Qualification Bachelor of Pharmacy

About The Role Skill required: Clinical Data Services - Clinical Data Management Designation: Clinical Data 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 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.A critical phase in clinical research that assures collection, integration and availability of data at appropriate quality and cost. It also supports the conduct, management and analysis of studies across the spectrum of clinical research as defined by the National Institutes of Health (NIH). What are we looking for Ability to establish strong client relationshipAbility to handle disputesAbility to manage multiple stakeholdersAbility to meet deadlinesAbility 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 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 Services - Safety Writing Designation: Pharmacovigilance Services Sr Analyst Qualifications: Bachelor of Pharmacy Years of Experience: 5 to 8 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. What are we looking for Ability to establish strong client relationship Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy

Project Role : Business Process Architect Project Role Description : Analyze and design new business processes to create the documentation that guides the implementation of new processes and technologies. Partner with the business to define product requirements and use cases to meet process and functional requirements. Participate in user and task analysis to represent business needs. Must have skills : SAP PP Production Planning & Control Discrete Industries Good to have skills : NAMinimum 12 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Business Process Architect, you will analyze and design new business processes to create the documentation that guides the implementation of new processes and technologies. Partner with the business to define product requirements and use cases to meet process and functional requirements. Participate in user and task analysis to represent business needs. 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.- Expected to provide solutions to problems that apply across multiple teams.- Collaborate with stakeholders to identify and document business requirements.- Design and implement business processes and workflows.- Analyze existing processes and identify areas for improvement.- Develop and maintain process documentation and standard operating procedures. Professional & Technical Skills: - Must To Have Skills: Proficiency in SAP PP Production Planning & Control Discrete Industries.- Strong understanding of business process analysis and design.- Experience in defining product requirements and use cases.- Knowledge of process improvement methodologies such as Lean or Six Sigma.- Experience with process modeling tools such as ARIS or Visio. Additional Information:- The candidate should have a minimum of 12 years of experience in SAP PP Production Planning & Control Discrete Industries.- This position is based at our Chennai office.- A 15 years full time education is required. Qualification 15 years full time education

Skill required: Pharmacovigilance Services - Safety Writing Designation: Pharmacovigilance Services Sr Analyst Qualifications: Bachelor of Pharmacy Years of Experience: 5 to 8 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. What are we looking for Ability to establish strong client relationship Roles and Responsibilities: oPrepare and review Aggregate reports and any adhoc reports requested by Client.oConduct or attend and contribute, as applicable, to a kick-off meeting and regular teleconferences with the Client during the preparation of Aggregate reports.oComplete all the sections of Aggregate Reports as per Client SOPs and guidelines and as agreed during kick-off meeting.oLiaise with relevant internal and Client stakeholders for the inputs required for the Aggregate Reports.oCoordinate data cleaning process (missing data clearance and send request for stop/ resume book in of cases) prior to final listings generation.oPerform activities as lead author and prepare submission ready draft for Aggregate reports.oPerform QC of the assigned draft Aggregate reports, per scorecard agreed with Client, and provide feedback to the responsible author with the duly filled scorecard defect tracker.oReview source documentation provided by Client for completeness and accuracy.oFacilitate stakeholders review as defined by the Client.oShall address all the comments received from all the stakeholders including review comments and provide the respective final versions of the reports to the Client ready for publishing.oOn-time escalation of any delayed inputs. Qualification Bachelor of Pharmacy

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

Job Summary We are seeking an experienced professional for the role of TL-Pharmacovigilance with 6 to 9 years of experience. The ideal candidate will have expertise in Pharma Research & Development and proficiency in MS Excel. Experience in PV Case Processing and Pharmacovigilance & Safety Ops is a plus. The role involves a hybrid work model with rotational shifts. Responsibilities Oversee the pharmacovigilance activities to ensure compliance with regulatory requirements and company standards. Provide expertise in Pharma Research & Development to enhance the quality and efficiency of safety operations. Utilize MS Excel to analyze and report pharmacovigilance data accurately and efficiently. Coordinate with cross-functional teams to ensure seamless integration of safety data into the overall drug development process. Monitor and evaluate adverse event reports to identify potential safety signals and trends. Ensure timely and accurate case processing in accordance with standard operating procedures. Collaborate with global teams to harmonize pharmacovigilance practices and share best practices. Develop and implement safety monitoring plans to proactively manage potential risks. Conduct regular audits and assessments to ensure compliance with pharmacovigilance regulations. Provide training and guidance to junior staff on pharmacovigilance processes and procedures. Support the preparation of safety reports and regulatory submissions. Engage in continuous improvement initiatives to enhance pharmacovigilance operations. Maintain up-to-date knowledge of pharmacovigilance regulations and industry trends. Qualifications Demonstrate strong expertise in Pharma Research & Development with a focus on safety operations. Exhibit proficiency in MS Excel for data analysis and reporting. Possess experience in PV Case Processing and Pharmacovigilance & Safety Ops as a valuable asset. Show ability to work effectively in a hybrid work model with rotational shifts. Display excellent communication and collaboration skills to work with cross-functional teams. Have a keen eye for detail and a proactive approach to identifying and managing risks. Certifications Required Certified Pharmacovigilance Professional (CPP) or equivalent certification preferred.

Manage DNA Slim protocol, medical reviews & reporting Oversee slimming programs and supervise the team Drive team performance, event participation, and client conversions Ensure scientific planning and tracking of each clientjourney

About The Role Project Role : Tech Delivery Subject Matter Expert Project Role Description : Drive innovative practices into delivery, bring depth of expertise to a delivery engagement. Sought out as experts, enhance Accentures marketplace reputation. Bring emerging ideas to life by shaping Accenture and client strategy. Use deep technical expertise, business acumen and fluid communication skills, work directly with a client in a trusted advisor relationship to gather requirements to analyze, design and/or implement technology best practice business changes. Must have skills : Oracle Argus Good to have skills : NAMinimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Tech Delivery Subject Matter Expert, you will drive innovative practices into delivery and bring depth of expertise to various engagements. Your typical day will involve collaborating with clients to gather requirements, analyzing their needs, and implementing technology best practices. You will be sought out for your expertise, enhancing the reputation of the organization in the marketplace. By shaping strategies for both Accenture and its clients, you will bring emerging ideas to life, ensuring that the delivery of services meets the highest standards of excellence. Your role will also require you to communicate effectively, fostering trusted advisor relationships with clients to facilitate successful 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.- Mentor junior professionals to enhance their skills and knowledge.- Continuously assess and improve delivery processes to ensure efficiency and effectiveness. Professional & Technical Skills: - Must To Have Skills: Proficiency in Oracle Argus.- Good To Have Skills: Experience with data analysis and reporting tools.- Strong understanding of project management methodologies.- Ability to communicate complex technical concepts to non-technical stakeholders.- Experience in developing and implementing technology strategies. Additional Information:- The candidate should have minimum 5 years of experience in Oracle Argus.- This position is based at our Bengaluru office.- A 15 years full time education is required. Qualification 15 years full time education

About The Role Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Oracle Argus Good to have skills : NAMinimum 3 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Developer, you will engage in the design, construction, and configuration of applications tailored to fulfill specific business processes and application requirements. Your typical day will involve collaborating with team members to understand project needs, developing innovative solutions, and ensuring that applications function seamlessly to support organizational goals. You will also participate in testing and troubleshooting to enhance application performance and user experience, contributing to the overall success of the projects you are involved in. Roles & Responsibilities:- Expected to perform independently and become an SME.- Required active participation/contribution in team discussions.- Contribute in providing solutions to work related problems.- Assist in the documentation of application specifications and user guides.- Engage in continuous learning to stay updated with the latest technologies and methodologies. Professional & Technical Skills: - Must To Have Skills: Proficiency in Oracle Argus.- Strong analytical and problem-solving skills.- Experience with application development methodologies.- Familiarity with software testing and debugging processes.- Ability to work collaboratively in a team environment. Additional Information:- The candidate should have minimum 3 years of experience in Oracle Argus.- This position is based at our Bengaluru office.- A 15 years full time education is required. Qualification 15 years full time education

Job Summary We are seeking a skilled BD Analyst with 4 to 5 years of experience in Pharma Research & Development. The ideal candidate will excel in analyzing business data to support strategic decisions focusing on enhancing the efficiency and effectiveness of our R&D processes. This hybrid role offers the opportunity to work in a dynamic environment contributing to impactful projects that drive innovation in the pharmaceutical industry. Responsibilities Analyze complex business data to identify trends and insights that support strategic decision-making in Pharma R&D. Collaborate with cross-functional teams to gather and interpret data ensuring alignment with business objectives. Develop and maintain data models and reporting systems to enhance data-driven decision-making processes. Provide actionable insights and recommendations to improve R&D processes and outcomes. Ensure data accuracy and integrity by implementing robust data validation and quality control measures. Support the development of business cases for new projects and initiatives by providing detailed data analysis. Monitor and report on key performance indicators to track progress and identify areas for improvement. Utilize advanced analytical tools and techniques to extract meaningful insights from large datasets. Communicate findings and recommendations to stakeholders through clear and concise reports and presentations. Stay updated with industry trends and best practices to continuously improve data analysis methodologies. Work closely with IT teams to ensure data systems and infrastructure support business needs. Contribute to the development of data governance policies and procedures to ensure compliance and data security. Participate in training and development programs to enhance skills and knowledge in data analysis and Pharma R&D. Qualifications Possess a strong background in Pharma Research & Development with a focus on data analysis. Demonstrate proficiency in using analytical tools and software for data modeling and reporting. Exhibit excellent problem-solving skills and attention to detail in data validation and quality control. Have experience in Aggregate (PSUR) reporting and PV Case Processing is a plus. Show ability to communicate complex data insights to non-technical stakeholders effectively. Display a proactive approach to learning and staying updated with industry trends. Work effectively in a hybrid work model balancing remote and in-office responsibilities. Certifications Required Certified Business Analysis Professional (CBAP) or equivalent certification in data analysis.

Job Summary We are seeking an experienced professional for the role of TL-Pharmacovigilance with 6 to 9 years of experience. The ideal candidate will have expertise in Pharma Research & Development and proficiency in MS Excel. Experience in PV Case Processing and Pharmacovigilance & Safety Ops is a plus. The role involves a hybrid work model with rotational shifts. Responsibilities Oversee the pharmacovigilance activities to ensure compliance with regulatory requirements and company standards. Provide expertise in Pharma Research & Development to enhance the quality and efficiency of safety operations. Utilize MS Excel to analyze and report pharmacovigilance data accurately and efficiently. Coordinate with cross-functional teams to ensure seamless integration of safety data into the overall drug development process. Monitor and evaluate adverse event reports to identify potential safety signals and trends. Ensure timely and accurate case processing in accordance with standard operating procedures. Collaborate with global teams to harmonize pharmacovigilance practices and share best practices. Develop and implement safety monitoring plans to proactively manage potential risks. Conduct regular audits and assessments to ensure compliance with pharmacovigilance regulations. Provide training and guidance to junior staff on pharmacovigilance processes and procedures. Support the preparation of safety reports and regulatory submissions. Engage in continuous improvement initiatives to enhance pharmacovigilance operations. Maintain up-to-date knowledge of pharmacovigilance regulations and industry trends. Qualifications Demonstrate strong expertise in Pharma Research & Development with a focus on safety operations. Exhibit proficiency in MS Excel for data analysis and reporting. Possess experience in PV Case Processing and Pharmacovigilance & Safety Ops as a valuable asset. Show ability to work effectively in a hybrid work model with rotational shifts. Display excellent communication and collaboration skills to work with cross-functional teams. Have a keen eye for detail and a proactive approach to identifying and managing risks. Certifications Required Certified Pharmacovigilance Professional (CPP) or equivalent certification preferred.

Job Summary We are seeking an experienced professional for the role of TL-Pharmacovigilance with 6 to 9 years of experience. The ideal candidate will have expertise in Pharma Research & Development and proficiency in MS Excel. Experience in PV Case Processing and Pharmacovigilance & Safety Ops is advantageous. The role involves working in a hybrid model with rotational shifts. Responsibilities Lead pharmacovigilance activities to ensure compliance with regulatory requirements and company standards. Oversee the collection assessment and reporting of adverse event data to maintain patient safety. Provide expert guidance on pharmacovigilance processes and ensure timely case processing. Collaborate with cross-functional teams to enhance safety operations and improve efficiency. Utilize MS Excel to analyze data and generate reports for stakeholders. Monitor trends in safety data and recommend actions to mitigate potential risks. Ensure accurate documentation and maintenance of pharmacovigilance records. Develop and implement strategies to optimize pharmacovigilance workflows. Conduct training sessions to enhance team knowledge and skills in safety operations. Support the development of pharmacovigilance policies and procedures. Engage with external partners to align on safety standards and practices. Contribute to the continuous improvement of pharmacovigilance systems and tools. Participate in audits and inspections to ensure compliance with industry regulations. Qualifications Possess a strong background in Pharma Research & Development with a focus on safety. Demonstrate proficiency in MS Excel for data analysis and reporting. Experience in PV Case Processing is highly desirable. Familiarity with Pharmacovigilance & Safety Ops is a plus. Ability to work effectively in a hybrid model with rotational shifts. Strong analytical and problem-solving skills. Excellent communication and collaboration abilities. Certifications Required Certification in Pharmacovigilance or Drug Safety is preferred.

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: BSc/Bachelor of Pharmacy/Bachelor of Physiotheraphy Years of Experience: 1 to 3 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.In this role, you will be expected to create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for? Agility for quick learning Adaptable and flexible Ability 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 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 Qualifications BSc,Bachelor of Pharmacy,Bachelor of Physiotheraphy

- Title - Safety & PV Spec I - Experience - 1-2.5 years of PV, experience - Job Location -Office based at Gurgaon / HYD Hybrid - Qualification Education B.Pharm / M.Pharm / BDS / BMS / MBBS (No BSc / MSc) - ICSR Case processing -Spontaneous is mandatory - English communications skill is important - Medical Knowledge - Terminology - Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required. - Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required. - Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability. - Enters data into safety database. - Codes events, medical history, concomitant medications, and tests. - Compiles complete narrative summaries. - Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved. - Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements. - Maintains safety tracking for assigned activities. - Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required. - Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA. - Manual recoding of un-recoded product and substance terms arises from ICSRs. - Identification and management of duplicate ICSRs. - Activities related to SPOR / IDMP. - Quality review of ICSRs. - Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate. - Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process. - Fosters constructive and professional working relationships with all project team members, internal and external. - Participates in audits as required/appropriate. - Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities.

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

As a member of Safety Operations Literature team within Global Patient Safety (GPS). This position serves as a subject matter expert for individual case safety reporting both in general and specific to scientific literature. Individuals will perform quality review of work performed by the PV outsource vendor providing instruction and training as needed. This position collaborates with others outside of team to review, rectify and reconcile data. What you'll be doing Supervise quality of abstract review, article review, and individual cases processed by PV agencies through random QC of cases or through review of aggregate data. Provide training to outsource vendor for Literature review and case processing. This includes coordinating new hire training and certification and ongoing training and feedback for existing vendor staff. Process literature adverse event reports as needed as a part of a cross-functional team. Interface and collaborate with other functional partners at Baxter (eg, Regulatory Affairs, IT, Legal, Customer Service, etc) Collaborate with local and regional Patient Safety team members to facilitate the global exchange of safety information. Participate in compliance supervising related activities including CAPA and Quality Control Metrics. What you'll bring Bachelors or Masters degree in Pharmacy Minimum 2 years patient care, or equivalent experience AND minimum 1 year experience required as Safety Review Specialist or proficiency in a Global Safety Database (eg, ARISg, Argus) Knowledge of multiple therapeutic areas equivalent position Experience in pharmaceutical industry- Quality, Pharmacovigilance or Regulatory department Excellent analytical & problem-solving skills Excellent oral and written communication Collaborative interpersonal skills to cultivate a team environment Ability to work independently under deadlines and changing priorities Able to multitask and prioritize changing workload every day In-depth knowledge of worldwide and regional safety regulations

As a PV Specialist, you will be integral to our pharmacovigilance efforts, handling key tasks such as: Data Entry: Accurately input data into the PV database. Initial Assessment: Perform initial assessments of Individual Case Safety Reports (ICSRs), as applicable. Expedited Reporting Evaluation: Evaluate the necessity for expedited reporting to Health Authorities or client partners, including adherence to reporting timelines. Reporting Preparation: Prepare standard reporting forms (e.g., CIOMS I, MedWatch Forms, and XML for submission. Follow-Up Requests: Prepare and send follow-up requests to obtain additional information as necessary. ICSR Submission: Submit ICSRs to Health Authorities and client partners, ensuring compliance with regulatory requirements. Case Completion: Ensure thorough documentation and completion of cases. Quality Check: Conduct quality checks on ICSRs to maintain data integrity. Search/Retrieval: Perform the ICSR search and retrieval process from the EVWEB database and assess cases from both company and non-company sources. Case Management: Allocate and manage cases effectively within the team. Training: Provide training on the system to team members to enhance their operational capabilities. Additional Responsibilities: Undertake other tasks as assigned by the Management team. Your Profile: Experience: Minimum 1 year of case processing experience. Software Knowledge: Proficient in ARGUS and ARISG. Qualification: B.Pharm, BDS, Pharm D, or M.Pharm. Communication Skills: Excellent verbal and written communication skills. Work Environment: Willingness to work from the office in Noida.

Undertake primary medical review of cases, including medical assessment of the case for seriousness, listedness/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