Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: 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 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. MICC experience and ready to work in any shiftIn 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. MICC experience and ready to work in any shift What are we looking for? Adaptable and flexible Ability to perform under pressure Written and verbal communicationMICC experience and ready to work in any shift 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 Bachelor of Pharmacy,Master of Pharmacy

Skill required: Pharmacovigilance Services - Medical Affairs Designation: Pharmacovigilance Services Specialist Qualifications: MBBS Years of Experience: 2 to 4 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 Medical Affairs, you will have to design, develop and deliver business solutions related to the medical affairs group of pharmaceutical companies, including thought leadership development, medical publications, education and information, medical grants, advisory boards and advocacy, regulatory review and approval of pharmaceutical drugs and perform publishing and quality control tasks on submission components. What are we looking for? Adaptable and flexible Agility for quick learning Ability to work well in a team 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 Qualifications MBBS

Skill required: Clinical Data Services - Clinical EDC Build Designation: Clinical Data Svs Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 3 to 5 years Language - Ability: English(International) - Expert What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.You will be expected to develop clinical study databases by building electronic case report forms and program edit checks as per specifications. Support any updates or changes to the study database (e.g. Protocol amendments) through the change control process. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship Roles and Responsibilities: Clinical Database Developers:Overall experience of 4+ years with exposure to EDC platforms like Medidata RAVE EDC, Inform, Oracle Clinical, Veeva etc. preferred.Extensive experience in database design, edit check programming, custom function programming and unit testing.Experienced in various modules such as IVRS/RWS integration and Lab administration. Medidata RAVE study builder certified preferred.

Skill required: Clinical Data Services - Clinical EDC Build Designation: Clinical Data Svs Sr Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 5 to 8 years Language - Ability: English(International) - Expert What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.You will be expected to develop clinical study databases by building electronic case report forms and program edit checks as per specifications. Support any updates or changes to the study database (e.g. Protocol amendments) through the change control process. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship Roles and Responsibilities: Overall experience of 4+ years with exposure to EDC platforms like Medidata RAVE EDC, Inform, Oracle Clinical, Veeva etc. preferred.Extensive experience in database design, edit check programming, custom function programming and unit testing.Experienced in various modules such as IVRS/RWS integration and Lab administration. Medidata RAVE study builder certified preferred.

Skill required: Clinical Data Services - Clinical EDC Build Designation: Clinical Data Svs Specialist Qualifications: BSc/Master of Pharmacy Years of Experience: 7 to 11 years Language - Ability: English(International) - Expert What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.You will be expected to develop clinical study databases by building electronic case report forms and program edit checks as per specifications. Support any updates or changes to the study database (e.g. Protocol amendments) through the change control process. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship Roles and Responsibilities: Data Review Report Programmers:Overall experience of 4+ years in Clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry preferred.Participate in the lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders.Facilitate interaction with end user on creating specifications and working with programmers or performing the programming activities for successful delivery.Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, SAS, and JReview etc. preferred.

Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Sr Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 5 to 8 years Language - Ability: English(International) - Expert What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.You will be expected to develop and review complex edit checks, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship Roles and Responsibilities: Data Review Report Programmers:Overall experience of 4+ years in Clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry preferred.Participate in the lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support.Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders.Facilitate interaction with end user on creating specifications and working with programmers or performing the programming activities for successful delivery.Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, SAS, and JReview etc. preferred.

Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Sr Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 5 to 8 years Language - Ability: English(International) - Expert What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.You will be expected to develop and review complex edit checks, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship Roles and Responsibilities: Data Review Report Programmers:Overall experience of 4+ years in Clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry preferred.Participate in the lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support.Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders.Facilitate interaction with end user on creating specifications and working with programmers or performing the programming activities for successful delivery.Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, SAS, and JReview etc. preferred.

Entity :- Accenture Strategy & Consulting Team :- Global Network Data & AI Practice :- Life Sciences Title :- Ind&Func AI Decision Science Manager Job Location :- Delhi, Gurgaon, Mumbai, Bangalore About S&C - Global Network :- Accenture GN's Data & AI (AI Hub India) practice helps our clients grow their business in entirely new ways. Analytics enables our clients to achieve high performance through insights from data - insights that inform better decisions and strengthen customer relationships. From strategy to execution, Accenture works with organizations to develop analytic capabilities - from accessing and reporting on data to predictive modeling to outperform the competition. WHAT'S IN IT FOR YOU? An opportunity to work on high-visibility projects with top Pharma clients around the globe. Potential to Co-create with leaders in strategy, industry experts, enterprise function practitioners, and business intelligence professionals to shape and recommend innovative solutions that leverage emerging technologies. Ability to embed responsible business into everything"from how you service your clients to how you operate as a responsible professional. Personalized training modules to develop your strategy & consulting acumen to grow your skills, industry knowledge, and capabilities. Opportunity to thrive in a culture that is committed to accelerating equality for all. Engage in boundaryless collaboration across the entire organization. Qualifications What you would do in this role Support delivery of small to medium-sized teams to deliver consulting projects for global clients. Responsibilities may include strategy, implementation, process design, and change management for specific modules. Manage daily operations within the team, guide & counsel the team members towards driving the Solution delivery to the Client. Participating in client discussions, developing new industry Point of View (PoV), re-usable assets (tools) Translate complex analytical findings into clear and concise reports and presentations for various stakeholders, including clinicians, executives, and patients (depending on the role). Provide Subject matter expertise in various sub-segments of the LS industry. Develop assets and methodologies, point-of-view, research, or white papers for use by the team and the larger community. Acquire new skills that have utility across industry groups. Support strategies and operating models focused on some business units and assess likely competitive responses. Also, assess implementation readiness and points of greatest impact. Co-lead proposals, and business development efforts and coordinate with other colleagues to create consensus-driven deliverables. Execute a transformational change plan aligned with the clients business strategy and context for change. Engage stakeholders in the change journey and build commitment to change. Make presentations wherever required to a known audience or client on functional aspects of his or her domain. Who are we looking for? Proven experience (10 + years) in working on Life Sciences/Pharma/Healthcare projects and delivering successful outcomes. Familiarity with assets OR tools in business consulting (R&D), such as issue trees, implementation frameworks, diagnosis tools like client questionnaire and analysis, operating model, business process mapping, and so on. Preferably worked with R&D functions such as Laboratory functions (R&D and Quality Check labs), clinical operations and development, decentralized clinical trials, pharmacovigilance, regulatory, quality management system, in capacity of a business analyst or management consultant. Working knowledge of clinical data management platforms such as Medidata/ RAVE, Veeva Clinical suite, pharmacovigilance databases ArisG & ARGUS databases, Regulatory Information Management Systems (Veeva RIM), lab informatics is desirable Leverage ones hands-on experience of working across one or more of these areas such as real-world evidence data, R&D clinical data, and digital marketing data. Familiarity with assets OR tools in business consulting (R&D), such as issue trees, implementation frameworks, diagnosis tools like client questionnaire and analysis, operating model, business process mapping, and so on. Preferably worked with R&D functions such as Laboratory functions (R&D and Quality Check labs), clinical operations and development, decentralized clinical trials, pharmacovigilance, regulatory, quality management system, in capacity of a business analyst or management consultant. Working knowledge of clinical data management platforms such as Medidata/ RAVE, Veeva Clinical suite, pharmacovigilance databases ArisG & ARGUS databases, Regulatory Information Management Systems (Veeva RIM), lab informatics is desirable Excellent analytical and problem-solving skills, with a data-driven mindset. Proficient in Excel, MS Word, PowerPoint, etc. Ability to solve complex business problems and deliver client delight. Strong writing skills to build points of view on current industry trends. Good Client handling skills; able to demonstrate thought leadership & problem-solving skills.

Entity :- Accenture Strategy & Consulting Team :- Global Network Data & AI Practice :- Life Sciences Title :- Ind&Func AI Decision Science Manager Job Location :- Delhi, Gurgaon, Mumbai, Bangalore About S&C - Global Network :- Accenture GN's Data & AI (AI Hub India) practice helps our clients grow their business in entirely new ways. Analytics enables our clients to achieve high performance through insights from data - insights that inform better decisions and strengthen customer relationships. From strategy to execution, Accenture works with organizations to develop analytic capabilities - from accessing and reporting on data to predictive modeling to outperform the competition. WHAT'S IN IT FOR YOU? An opportunity to work on high-visibility projects with top Pharma clients around the globe. Potential to Co-create with leaders in strategy, industry experts, enterprise function practitioners, and business intelligence professionals to shape and recommend innovative solutions that leverage emerging technologies. Ability to embed responsible business into everything"from how you service your clients to how you operate as a responsible professional. Personalized training modules to develop your strategy & consulting acumen to grow your skills, industry knowledge, and capabilities. Opportunity to thrive in a culture that is committed to accelerating equality for all. Engage in boundaryless collaboration across the entire organization. Qualifications What you would do in this role Support delivery of small to medium-sized teams to deliver consulting projects for global clients. Responsibilities may include strategy, implementation, process design, and change management for specific modules. Manage daily operations within the team, guide & counsel the team members towards driving the Solution delivery to the Client. Participating in client discussions, developing new industry Point of View (PoV), re-usable assets (tools) Translate complex analytical findings into clear and concise reports and presentations for various stakeholders, including clinicians, executives, and patients (depending on the role). Provide Subject matter expertise in various sub-segments of the LS industry. Develop assets and methodologies, point-of-view, research, or white papers for use by the team and the larger community. Acquire new skills that have utility across industry groups. Support strategies and operating models focused on some business units and assess likely competitive responses. Also, assess implementation readiness and points of greatest impact. Co-lead proposals, and business development efforts and coordinate with other colleagues to create consensus-driven deliverables. Execute a transformational change plan aligned with the clients business strategy and context for change. Engage stakeholders in the change journey and build commitment to change. Make presentations wherever required to a known audience or client on functional aspects of his or her domain. Who are we looking for? Proven experience (10 + years) in working on Life Sciences/Pharma/Healthcare projects and delivering successful outcomes. Familiarity with assets OR tools in business consulting (R&D), such as issue trees, implementation frameworks, diagnosis tools like client questionnaire and analysis, operating model, business process mapping, and so on. Preferably worked with R&D functions such as Laboratory functions (R&D and Quality Check labs), clinical operations and development, decentralized clinical trials, pharmacovigilance, regulatory, quality management system, in capacity of a business analyst or management consultant. Working knowledge of clinical data management platforms such as Medidata/ RAVE, Veeva Clinical suite, pharmacovigilance databases ArisG & ARGUS databases, Regulatory Information Management Systems (Veeva RIM), lab informatics is desirable Leverage ones hands-on experience of working across one or more of these areas such as real-world evidence data, R&D clinical data, and digital marketing data. Familiarity with assets OR tools in business consulting (R&D), such as issue trees, implementation frameworks, diagnosis tools like client questionnaire and analysis, operating model, business process mapping, and so on. Preferably worked with R&D functions such as Laboratory functions (R&D and Quality Check labs), clinical operations and development, decentralized clinical trials, pharmacovigilance, regulatory, quality management system, in capacity of a business analyst or management consultant. Working knowledge of clinical data management platforms such as Medidata/ RAVE, Veeva Clinical suite, pharmacovigilance databases ArisG & ARGUS databases, Regulatory Information Management Systems (Veeva RIM), lab informatics is desirable Excellent analytical and problem-solving skills, with a data-driven mindset. Proficient in Excel, MS Word, PowerPoint, etc. Ability to solve complex business problems and deliver client delight. Strong writing skills to build points of view on current industry trends. Good Client handling skills; able to demonstrate thought leadership & problem-solving skills. Accenture is an equal opportunities employer and welcomes applications from all sections of society and does not discriminate on grounds of race, religion or belief, ethnic or national origin, disability, age, citizenship, marital, domestic or civil partnership status, sexual orientation, gender identity, or any other basis as protected by applicable law.

Skill required: Com.Bkg- Commercial Real Estate - Real Estate Due Diligence Designation: Banking Advisory Associate Qualifications: BCom Years of Experience: 1 to 3 years What would you do? We help clients address quality and productivity issues, keep pace with customer expectations, navigate regulatory and operational pressures and ensure business sustainability by transforming their banking operations into an agile, resilient operating model.The Corporate banking /Wholesale banking team is responsible for helping clients and organizations processes trade finance transactions by providing superior service delivery to trade customers whilst safeguarding the bank from risks associated with this business.Identify and assess, prevent and mitigate and account to provide reasonable measures to adapt before executing an agreement in relation to the real estate and immovable property. Valuation of commercial real estate using software like Argus, extracting key information from lease agreements (including amendments) and rent rolls. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship 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 BCom

Skill required: Com.Bkg- Commercial Real Estate - Real Estate Due Diligence Designation: Banking Advisory Analyst Qualifications: BCom Years of Experience: 3 to 5 years What would you do? We help clients address quality and productivity issues, keep pace with customer expectations, navigate regulatory and operational pressures and ensure business sustainability by transforming their banking operations into an agile, resilient operating model.The Corporate banking /Wholesale banking team is responsible for helping clients and organizations processes trade finance transactions by providing superior service delivery to trade customers whilst safeguarding the bank from risks associated with this business.Identify and assess, prevent and mitigate and account to provide reasonable measures to adapt before executing an agreement in relation to the real estate and immovable property. Valuation of commercial real estate using software like Argus, extracting key information from lease agreements (including amendments) and rent rolls. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualifications BCom

Project Role : Program/Project Management Lead Project Role Description : Manage overall delivery of a program or project to achieve business outcomes. Define project scope and monitor execution of deliverables. Communicate across multiple stakeholders to manage expectations, issues and outcomes. Must have skills : Pharmacovigilance & Drug Safety Surveillance Good to have skills : NA Minimum 12 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Program/Project Management Lead, you will oversee the delivery of programs or projects to achieve business objectives. You will define project scope, monitor execution, and communicate with stakeholders to manage expectations and outcomes effectively. Roles & Responsibilities: Involve monitoring and assessing the risks and benefits of medicines to patients, so it's vital for anyone working in this profession that the information they work on is accurate. Candidates will need to be thorough and precise in their work, paying attention to detail, as jobs in the pharmacovigilance sector require a responsible attitude. Incorrect information can have serious health and safety consequences. 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. Lead project planning and execution. Ensure project scope and objectives are clearly defined. Monitor project progress and address any issues. Communicate effectively with stakeholders to manage expectations. Professional & Technical Skills: -Observational skills as well as attention to detail-Analytical and problem-solving skills-Excellent communication skills, both written and verbalIT skills-Team working skills-Mathematical skills Project management and planning skills Ability to work in a fast-paced environment Additional Information: The candidate should have a minimum of 12 years of experience in Pharmacovigilance & Drug Safety Surveillance. This position is based at our Bengaluru office. A 15 years full time education is required. Qualifications 15 years full time education

Responsible for research and authoring of scientific response documents under the direction of the Global Medical Information (GMI) team in support of global and local medical information activities. Responsible for the execution of activities as required in alignment with GMI colleagues. Achieved through a combination of product knowledge, along with editing, writing, and document management proficiency. Essential Job duties and responsibilities: 1) Conducts literature searches and reviews, and extracts/summarizes complex data from the scientific literature. 2) Generates evidence-based, accurate, current, and fair-balanced summaries of data for the creation/maintenance of scientific response documents for products in designated therapeutic area(s). 3) Adapts global scientific response documents for assigned countries. 4) Develops responses to escalated inquiries for assigned countries. 5) Develops contributions to US NDA Annual Reports. 6) Contributes to US compendia reviews. 7) Contributes to peer reviews. 8) Demonstrates resolve and urgency to accomplish tasks without direct authority or control. Participate in cross-functional project teams as needed. Ensure that assigned projects are completed on schedule. 9) Develops and maintains Therapeutic Area expertise. 10) Reviews the content created by peer writers. 11) Collaborates effectively with Global Medical Information teams to execute content plans People: 1) Maintain effective relationships with the end stakeholders (Medical scientific community) within the allocated Global business unit and product - with an end objective to develop medical information content as per requirement. 2) Interact effectively with stakeholders in medical and pharmacovigilance departments. 3) Constantly assist other medical information writers in developing knowledge and sharing expertise. Performance: Provide deliverables (scientific response documents, US NDA Annual Reports, US compendia reviews) as per agreed timelines and quality Process: 1) Act as an expert in the field of medical information writing and maintain on the regulatory requirement for countries supported. 2) Assist the assigned medical information team in conducting a comprehensive medical writing needs analysis. 3) Implement relevant elements of content plans and associated activities for the year identified for the assigned countries. 4) Work with selected vendors within the region to deliver the required deliverables as per the defined process. 5) Design an overall plan of action basis end-customers feedback & improve course content and delivery. Stakeholders: 1) Work closely with medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables. 2) Liaise with the Medical department to prepare relevant & customized deliverables.

The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process and determine the medical and scientific relevance of serious adverse event reports within the context of the product s safety profile as well as other products within the same therapeutic area. Also, this position plays a greater role as a senior technical leader and participate in matrix management activities including preparation or participation in evaluating safety issues and preparation of aggregate reports in collaboration with the Post-Marketing Safety Experts and Safety Surveillance Group and be responsible for surveillance activities for selected products. Essential Functions Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements Provide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported Perform medical safety review of the protocol, Investigative Brochure, and/or Case Report Forms (CRFs) for appropriate safety content and data capture, as applicable Provide aggregate reviews of safety information, including but not limited to clinical data, postmarketing, literature review and observational studies to maintain oversight of a product s safety profile (e.g: DSUR, RMP, PBRER, ad hoc regulatory reports etc) Ensure service delivery from productivity, compliance and quality perspective within regulatory /contracted timelines. Lead and participate in the initiatives taken for the same from team delivery perspective Provide therapeutic area/pharmacovigilance issue guidance in the context of leading/managing other safety team members in single case assessment. Ensure update of watch list, list of expectednsess, labeling list/RSIs etc for the assigned products and develop such additional capabilities within the team Lead, drive and participate in training activities, product transitions, audit preparation and knowledge exchange initiatives Review and sign off on the Project Safety Plan and Medical Monitoring Plan per medical safety scope agreed in contract, as applicable Attend project meetings, medical safety team meetings, and represent safety and clinical data review findings during client meetings, as applicable Act as Lead Safety Physician, or additional team support, and/or back up on assigned projects as applicable Provide medical escalation support for medical information and EU Qualified Persons for Pharmacovigilance projects, as applicable 24 hour medical support as required on assigned projects Maintain awareness of medical safety-regulatory industry developments Provide support and participate in signal detection efforts, e.g. strategy meetings etc. as applicable Qualifications Other A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education. Req Three (3 years) experience practicing clinical medicine after award of medical degree. Graduate, and/or Residency training can qualify for clinical practice experience Req Two (2) years of pharma experience Pref Sound knowledge of Medicine In-depth knowledge of applicable global, regional and local clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Knowledge of Pharmacovigilance- ICSR and Aggregate reports In-depth knowledge of departmental standard operating procedures (SOPs) Skill in use of multiple safety databases Adequate Computer skills, especially Microsoft word, excel & PowerPoint Good communication skills- verbal and written Ability to establish and maintain effective working relationships with managers, co-workers, investigative site staff, clients and regulatory agency representatives Ability to establish and maintain effective working relationships with coworkers, managers and clients A valid medical license, or equivalent, from the country or region in which he/she resides and works Pref

Job Description Jira Administrator About ArisGlobal (www.arisglobal.com): ArisGlobal is empowering life science organizations to deliver breakthroughs faster , accurately , and with precision. This is paramount for the passage of lifesaving medications and products VIA clinical trials, using our software and technology. As an industry leader, ArisGlobal provides our SaaS leading technology and services to 40/50 top Bio-pharmaceutical corporations, 4/5 of the most advanced global pharmaceutical companies and nine government-health authorities, including the FDA, Health Canada and the NMPA, for example, around the world. 2021 has presented simultaneous developments in the global Drug Safety and Pharmacovigilance Software Market, projecting unfaltering growth through 2027. Effectively harnessed by prominent market drivers, ArisGlobal is named a Key Player. Located in Miami, New Jersey, Budapest, Dublin, Darmstadt, Rome, Tokyo, Shanghai, Bangalore, Mysore, our global presence is clear, and we are growing faster than ever . Position Overview The Jira Admin will be responsible for the effective use and administration of Jira software across the organization. The role requires a deep understanding of Jiras functionality, configuration, and integration capabilities. The ideal candidate will be able to apply knowledge of different project management processes, design JIRA workflows with an agile mindset and support the implementation of JIRA and other applications within the Atlassian Marketplace. Required Skills and Experience Minimum of 3-5 years of experience working with Jira in a technical or administrative capacity. Proven experience configuring and administering Jira (Software, Service Management, Confluence, etc.). Strong understanding of Jira workflows, permissions, and automation rules. Experience integrating Jira with other tools (e.g., GitHub, Bitbucket, Slack). Ability to work effectively remotely in cross-functional teams. Ability to meet deadlines and produce quality work. Responsibilities Manage and configure Jira instances, including project creation, workflows, permissions, and user management. Administer Jira Software, Jira Service Management, and other Jira tools (e.g., Confluence, Bitbucket) for all teams within the organization. Customize Jira to support specific needs, including dashboards, reports, workflows, and custom fields. Work closely with stakeholders to understand project requirements and design solutions that optimize the use of Jira for project tracking and reporting. Conduct regular Jira audits and provide recommendations for performance improvements and efficient configurations. Ensure that workflows and automation rules are designed to meet the needs of the business and increase productivity. Act as the primary point of contact for Jira-related issues, providing troubleshooting support and ensuring the platform runs smoothly for users. Provide guidance and assistance on customizations, integrations, and issue resolution to team members. Develop training materials, documentation, and user guides to help employees effectively use Jira. Conduct regular training sessions, workshops, and onboarding for new users to ensure proficiency with Jira tools. Stay updated on Jira best practices and industry trends, ensuring the team is always using the latest features. Partner with cross-functional teams to ensure Jira aligns with business requirements and evolving needs. Provide ongoing consultation on Jira usage, suggesting improvements to maximize efficiency. Collaborate with IT teams to ensure Jira integrates seamlessly with other tools and systems used by the organization.

Tablets India Ltd. is looking for Marketing Executive (Medical Representative) to join our dynamic team and embark on a rewarding career journey Develop and maintain relationships with healthcare professionals and organizations Promote and sell our medical products and services to targeted customers Provide product demonstrations and education to customers Attend industry events and conferences to network and stay up to date on industry trends Maintain accurate records of sales activities and customer interactions Achieve sales targets and quotas Marketing Executive role is to promote Tablets India Ltd products to Medical professionals (doctors/ chemists etc.) and responsible for the generation of prescriptions to achieve given sales objective.

Tablets India Ltd. is looking for Marketing Executive (Medical Representative) to join our dynamic team and embark on a rewarding career journey Develop and maintain relationships with healthcare professionals and organizations Promote and sell our medical products and services to targeted customers Provide product demonstrations and education to customers Attend industry events and conferences to network and stay up to date on industry trends Maintain accurate records of sales activities and customer interactions Achieve sales targets and quotas Marketing Executive role is to promote Tablets India Ltd products to Medical professionals (doctors/ chemists etc.) and responsible for the generation of prescriptions to achieve given sales objective.

Tablets India Ltd. is looking for Marketing Executive (Medical Representative) to join our dynamic team and embark on a rewarding career journey Develop and maintain relationships with healthcare professionals and organizations Promote and sell our medical products and services to targeted customers Provide product demonstrations and education to customers Attend industry events and conferences to network and stay up to date on industry trends Maintain accurate records of sales activities and customer interactions Achieve sales targets and quotas Marketing Executive role is to promote Tablets India Ltd products to Medical professionals (doctors/ chemists etc.) and responsible for the generation of prescriptions to achieve given sales objective.

Tablets India Ltd. is looking for Marketing Executive (Medical Representative) to join our dynamic team and embark on a rewarding career journey Develop and maintain relationships with healthcare professionals and organizations Promote and sell our medical products and services to targeted customers Provide product demonstrations and education to customers Attend industry events and conferences to network and stay up to date on industry trends Maintain accurate records of sales activities and customer interactions Achieve sales targets and quotas Marketing Executive role is to promote Tablets India Ltd products to Medical professionals (doctors/ chemists etc.) and responsible for the generation of prescriptions to achieve given sales objective.

Tablets India Ltd. is looking for Marketing Executive (Medical Representative) to join our dynamic team and embark on a rewarding career journey Develop and maintain relationships with healthcare professionals and organizations Promote and sell our medical products and services to targeted customers Provide product demonstrations and education to customers Attend industry events and conferences to network and stay up to date on industry trends Maintain accurate records of sales activities and customer interactions Achieve sales targets and quotas Marketing Executive role is to promote Tablets India Ltd products to Medical professionals (doctors/ chemists etc.) and responsible for the generation of prescriptions to achieve given sales objective.

Tablets India Ltd. is looking for Marketing Executive (Medical Representative) to join our dynamic team and embark on a rewarding career journey Develop and maintain relationships with healthcare professionals and organizations Promote and sell our medical products and services to targeted customers Provide product demonstrations and education to customers Attend industry events and conferences to network and stay up to date on industry trends Maintain accurate records of sales activities and customer interactions Achieve sales targets and quotas Marketing Executive role is to promote Tablets India Ltd products to Medical professionals (doctors/ chemists etc.) and responsible for the generation of prescriptions to achieve given sales objective.

Tablets India Ltd. is looking for Marketing Executive (Medical Representative) to join our dynamic team and embark on a rewarding career journey Develop and maintain relationships with healthcare professionals and organizations Promote and sell our medical products and services to targeted customers Provide product demonstrations and education to customers Attend industry events and conferences to network and stay up to date on industry trends Maintain accurate records of sales activities and customer interactions Achieve sales targets and quotas Marketing Executive role is to promote Tablets India Ltd products to Medical professionals (doctors/ chemists etc.) and responsible for the generation of prescriptions to achieve given sales objective.

Tablets India Ltd. is looking for Marketing Executive (Medical Representative) to join our dynamic team and embark on a rewarding career journey Develop and maintain relationships with healthcare professionals and organizations Promote and sell our medical products and services to targeted customers Provide product demonstrations and education to customers Attend industry events and conferences to network and stay up to date on industry trends Maintain accurate records of sales activities and customer interactions Achieve sales targets and quotas Marketing Executive role is to promote Tablets India Ltd products to Medical professionals (doctors/ chemists etc.) and responsible for the generation of prescriptions to achieve given sales objective.

Tablets India Ltd. is looking for Marketing Executive (Medical Representative) to join our dynamic team and embark on a rewarding career journey Develop and maintain relationships with healthcare professionals and organizations Promote and sell our medical products and services to targeted customers Provide product demonstrations and education to customers Attend industry events and conferences to network and stay up to date on industry trends Maintain accurate records of sales activities and customer interactions Achieve sales targets and quotas Marketing Executive role is to promote Tablets India Ltd products to Medical professionals (doctors/ chemists etc.) and responsible for the generation of prescriptions to achieve given sales objective.

Tablets India Ltd. is looking for Marketing Executive (Medical Representative) to join our dynamic team and embark on a rewarding career journey Develop and maintain relationships with healthcare professionals and organizations Promote and sell our medical products and services to targeted customers Provide product demonstrations and education to customers Attend industry events and conferences to network and stay up to date on industry trends Maintain accurate records of sales activities and customer interactions Achieve sales targets and quotas Marketing Executive role is to promote Tablets India Ltd products to Medical professionals (doctors/ chemists etc.) and responsible for the generation of prescriptions to achieve given sales objective.