Shiva Shankar Varganti

· Acting as project manager for IDMP Project (IDMP Pitching to Management & other stakeholders, Authoring Project Initiating document, Project Mandate, Project Schedule etc, preparing budget estimate, establishing Project Team & Steering committee alignment, other resource & skill requirement, Hiring etc.)

· Drafting vendor scope & vendor assessment for the tools used for IDMP Project (Text Extraction-NLP, SPOR Alignment, Submission platform, Data visualization tool, data harmonization etc).

· Onboarding IDMP Key stakeholders & defining roles & responsibilities for all the actors in the project.

· Organizing project meetings like steering committee meeting, stakeholder meeting, team meeting’s etc.

· Establishing IDMP data governance, building IDMP data catalogue, data mapping, gap analysis etc.

· Aligning with all the key stakeholders on the IDMP project terms & establishing data flow, if required.

· Preparing business rules for the IDMP data fields & Establisng a process for monitoring quality.

· Lead IDMP Implementation sub projects like SPOR alignment, DADI readiness, IDMP PMS Text extraction, IRIS marketing status project, Veeva Vault RIMS xEVMPD & IDMP Module design, configuration & Implementation etc

· Incorporating IDMP process in existing change control procedures.

· Lead XEVMPD submissions, ensuring that electronic submissions meet the required quality standards with internal/external deadlines.

· Provide subject matter expertise on ISO IDMP Standards, EU Implementation Guide, and SPOR implementation.

· Networking and awareness activities that leads to a continuous stream of impending changes in electronic regulatory requirements.

· Participate in the migration of data between systems, as and when required.

· Responsible for providing the training, support and the end user communication for data management topics and also on IDMP intelligence.

· SOP/WI Effectiveness and compliance checking, including performing time-to-time updates to Global Regulatory processes as Continuous Improvement

. Collaborated with team members to achieve target results.

. Managing team of employees, overseeing hiring, training and professional growth of employees.

(A) xEVMPD Process Lead

(B) IDMP Readiness activities (Operational lead for IDMP Text Mining activities), SPOR Maintenance etc.

(C) Veeva Vault Operational & Reporting activities.

(A) xEVMPD Process lead

· Responsible for end-to-end xEVMPD submissions.

· Ensuring high quality in xEVMPD submission performed by the team.

· Responsible for verifying xEVMPD data wrt Annual PV fee & PSUSA fee advice notice data.

· Responsible for xEVMPD related Audits, Trainings, Brexit impact analysis, performing RCA for any deviation’s behalf of team, etc.

· Responsible for coordinating with QPPV, MPL, Vendor’s, CRA, etc, as required for alignment or Managing xEVMPD topic’s like EMA notices, Brexit, xEVMPD Quality aspects

· Responsible for clarifying xEVMPD related queries from QPPV office, MPL, Vendor’s, CRA’s or any other stakeholders.

· Responsibilities for hiring (in term’s of handling Technical round) xEVMPD/IDMP topics.

. Handling Brexit related changes in xEVMPD.

(B) IDMP Readiness activities.

· Performing IDMP Gap Analysis, Preparing Data Catalogue based on PMS guidelines & DADI form field’s.

· Managing SPOR Activities (Super user)

· Responsible for maintaining SPOR data base, specifically OMS & RMS.

· Responsible for approving SPOR & IRIS user access.

· Managing Organization data (OMS) & handling OMS related queries from stakeholders.

· Handling Organization data quality (OMS data) issues.

· Assisting in developing TextMining Tool for extracting IDMP data, providing requirement to IT team asper PMS guidelines, performing PQ Tests in HPALM, etc.

· Operational lead for IDMP Text mining activities which includes preparing guidelines, providing training, handling deliverables & assisting in tool development activities.

· Assisting in Anchoring workstreams for IDMP & RIMS Data migration activities.

· Handling IDMP Newsletter activities, which includes content collection, evaluation, designing & publishing internally.

(C) Veeva Vault Operational & Reporting activities.

Liquent RIMS to Veevavault Migration Activities

· Experience in handling Veeva Vault Migration activities like process design, data cleansing etc.

· Aligning with all stakeholder’s as part of newly created xEVMPD process flow

Operational Activities:

· Performing xEVMPD Submissions in Veevavault .

Veeva Reporting Activities

· To Create, test and validate new report types & reports in Sandbox Environment.

· To Collaborate with Informatics team to implement new report types in Veeva Vault Production Environment

· Supporting Veeva user’s & creating new simple, complex & MultiPass reports as per there requirements.

(A) EVMPD/IDMP/PV ICSR related Job Responsibilities

· Performing Register Data management activities.

· Responsible for Data Entry in Regulatory database (RIMS) for Registrations, Regulatory changes and updates.

· Ensuring high quality in data entry and complete tasks as per targets & timelines
Quality Check and Data Review.
Responsible for Quality check of data entry, insert, variation, and nullification processes (Register)

· Performing IDMP related activities

· Knowledge of xEVMPD submissions through Aris Global REGISTER which is a Regulatory Information Management System (RIMS).

· Identifying and Extraction of all the possible data fields going to be involved in IDMP.

· Verifying indication and undesirable effects coding of labeling documents and coding them appropriately using MedDRA and WHO DD dictionary.

· Preparing Standard Operating Procedures & WI as required.

· Evaluating New database for IDMP, as a pilot.

· Handling pharmacovigilance case processing activities (ICSR) activities for 3 clinical trials (Share basis model).

(B) Team Managing & Adhoc activities

· Preparing team utilization sheet every week.

· Dashboard (KPI) preparation for client perusal.

· Providing on job training to New joiners

· Assisting IT team in performing Annual Disaster management activities.

Legal Case Processing

· Performing data entry in ARGUS tool.

· Coding of events, symptoms and medical history using MedDRA, and suspected, treatment and concomitant drugs using WHO DDH.

· Writing narratives summarizing all relevant medical information for individual case safety reports in chronological order as per protocol.

· Raising and reframing queries to have complete information in the case.

· Participate in client meetings / project specific training sessions serve on departmental committees and projects as needed.

· Performing significant or non-significant corrections and maintain a track on it.

Vaccine Case Processing & POC for PV MailBox

· Monitoring and Handling the PVO mailbox, escalating if emails were not actioned within timeline (POC for PVO Mail box).

· Receiving cases and acknowledging them.

· Logging the cases received in Excel and identifying priority cases by performing initial safety review of adverse events to determine seriousness, expectedness and relatedness.

· Performing ICSR registration in PRIMO (PV software for non-connected sites)

· Performing ICSR registration i.e., duplicate check, triage, check within the Global Safety Databases (AWARE) case priority, awareness date and closure/submission timelines and internal and external completion/submission dates.

· Hands on experience for data entry of case reports (clinical trials and post-marketing) into safety database.

· Coding of events, symptoms and medical history using Medra, and suspected, treatment and concomitant drugs using WHO DDH.

· Writing narratives summarizing all relevant medical information for individual case safety reports in chronological order as per protocol.

· Raising and reframing queries to have complete information in the case.

· Participate in client meetings / project specific training sessions serve on departmental committees and projects as needed.

· Performing significant or non-significant corrections and maintain a track on it.