Benson Reddy. SB

Overall Purpose of the job is to Aligns Accenture Global, SDO and Client vision to delivery unit and to coordinate the work of the team to deliver quality service required by the client in accordance with agreed business plans. Take overall responsibility of service delivery and development of delivery unit.

Scope

• Operational responsibility for the delivery of assigned deal, ensuring provision of service and quality to meet service level agreements agreed with clients.
• Cost management for assigned deal.
• Manages service improvement program's within the delivery operation.
• Responsible for operations staff of assigned deal and for maintaining headcount to the agreed plan.

Role Accountability

• Is accountable for service delivery of assigned deal.
• Is responsible for monitoring service performance and taking action to identify root causes of issues and putting in place remedial actions.
• Is accountable for running continuous improvement program's and identifying service improvement opportunities.
• Is accountable for accenting new client deals into the service delivery centres and for signing off processes and configurations.

Operational

• Ensure timely adherence to all compliance requirements.
• Ensure adherence to client’s policies and procedures.
• Manage program's to grow skills and experience within the service delivery centre.
• Assist Accenture client partners to sell Health &Life Sciences and allied services to other clients.

Financial/Contract Management

• Responsible for cost management, including providing inputs for financial proposals and reviews; accountable for budget adherence.

People Management

• Responsible for staff assigned to the deals (working with the HR and Career Managers) including training, succession planning, morale, communication and resolution of any personnel issues.
• Responsible for timely completion of the performance management process in a fair and consistent manner.
• Responsible for ensuring the career development for direct reports.
• Communicate strategies / initiatives across the team.
• Review and develop the organizational structure in sync with business requirements.

Overall purpose of the job is to assist in floor operations by supporting case allocation using workflow tool, allocating Triage emails, acting as point of contact for Transport and procurement related activities, managing logistics for client visits, identifying potential gaps in allocation or prioritization and thus ensuring smooth flow of operations.

• Manage emails received for triage from client.
• Highlight potential capacity issues that may compromise regulatory submission compliance or quality.
• Update operational details into Digiview portal.
• Share reports to Pharma Project Management Office in timely manner.
• Share reports on Share Folder & C/D Drive reconciliation adhering to expectations in timely manner.
• Guide new joiners on Accenture Policies and Procedures.
• Manage details on weekend working/stretch hours of team members.
• Act as transport SPOC (single point of contact) and ensure concerns are effectively resolved by highlighting them in relevant forums.
• Manage Business continuity plan
• Act as SPOC for Facilities and Services, Procurement and Engagement related activities.
• Manage logistics.
• Internal Workflow tool – Upload cases into the tool and reconcile for discrepancies between client database and internal workflow tool.
• Assist managers to meet the overall compliance

Overall purpose of the job Guides and manages team members towards achieving the goals of the project, and serves as a liaison between management / client and team members

• Manage day to day operations (case allocation, monitoring workflow, taking action on emails from client stakeholders on case processing etc.) ensuring distribution of adverse event reports within agreed timelines.
• Manage resource allocation and strives to achieve optimal capacity utilization, takes appropriate actions to mitigate risks, if any.
• Facilitate operations call with client stakeholders, documents the meetings and takes appropriate actions as agreed in the meetings, as and when required.
• Highlight issues/concerns identified by the team members or client stakeholders to supervisor and drives for solution.
• Performs review, re-assign CAPAs to relevant owners and complete all Accenture related CAPAs in Trackwise accordance with Teva manuals Conduct performance review and provide timely feedback to team members, and documents it as per applicable procedures.
• Facilitates daily team huddle, and along with Trainers ensures all process related updates are discussed.
• Co-ordinate with Trainers and fellow Team leads efficiently, and ensures professional working conditions for team members.
• Drive retention of talent and highlights risks to supervisor in a timely manner.
• Propagate positive teamwork across work groups and drive business results.
• Drive continuous improvement within the process to maximize quality of the deliverables and improve efficiency.
• Perform QC for cases that were processed by new joiners as and when required.

Overall purpose of the job is to transcribe all pertinent data from adverse event reports into Client’s safety database and ensures accuracy of cases processed into Client’s safety database, complying with Client’s Standard Operating Procedures and guidelines.

• Identifies and selects cases from ARISE workflow, determining appropriate prioritization criteria and submission dates.
• Performs duplicate check in the ARISE database for the case.
• Reviews fields entered by Data Entry for completeness and accuracy and makes changes when required.
• Reviews coding of suspect drugs using Company Product Dictionary-CPD (Client products) and WHO Drug Dictionary (Non Client products).
• Reviews coding of Concomitant Drugs, Treatment Drugs and Past Drugs using WHO Drug Dictionary.
• Reviews adverse events and makes necessary changes as applicable per conventions.
• Reviews the seriousness criteria of all the events and upgrades events listed in “Client’s List of Adverse Event/Reaction Terms to be considered always Serious”, following the established procedure.
• Imports the case in MedDRA Coder Browser (MCB) to code Adverse Events, Indications of Suspect and Concomitant medications, Medical History and Laboratory investigations as per coding conventions.
• Performs Medical Triage as per labeling conventions.
• Imports the case in ANG tool to check for appropriateness and chronology, and make necessary changes to ensure all pertinent information is captured.
• Writes and edits the case narrative.
• Sends clarification email to Client affiliates team, as required.
• Determines and performs appropriate case follow-up, generating and requesting follow-up queries.
• Implements MedDRA recodes for serious cases.
• Checks follow-up query requests from Document specialist and suggests if further follow-up query is needed for a case.
• Assists in other case processing post-marketing related activities.

Overall purpose of the job is to transcribe all pertinent data from adverse event reports into Client’s safety database and ensures accuracy of cases processed into Client’s safety database, complying with Client’s Standard Operating Procedures and guidelines.

• Accountable for performing timely and accurate data capture for individual case safety reports from both Solicited and non-solicited (clinical trail cases, literature cases, Spontaneous etc) source of origin to meet regulatory reporting requirements.
• Confirms the case validity, seriousness, event term selection, coding of adverse events, suspect products, concomitant medications, lab investigations and overall consistency of information.
• Determines whether or not the follow-up information is medically significant or relevant and takes necessary actions.
• Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately.
• Review, rank, verify, process and document: event terms; case classifications (validity, seriousness, expectedness/listedness/labelledness); special scenarios; product complaint information; reportability with due date; and accuracy and consistency.
• Based on assessment of cases, process accordingly.
• Review case criteria to determine the appropriate workflow for case processing.
• Write and edit the narrative.
• Determine and perform appropriate case follow-up and request for follow-up letters.
• Identify any additional queries for any missing data or clarification and document appropriately in the global safety database with a brief description of the additional information needed.
• Reviewing individual cases, line listings (Individual Case Safety Report (ICSR) line listing, periodic and PSUR report listings), and other safety reports for consistency and accuracy of safety information, as well as appropriate coding of adverse event terms and drugs as per established coding guidelines, where applicable.