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Click here or scroll down to respond to this candidateCandidate's Name , (MS Bio-Tech)Ph # PHONE NUMBER AVAILABLEEmail: EMAIL AVAILABLEFlexible, Ability to support any time zone. Experienced in working with global teams, able to reasonably accommodate meetings per their time zones.Experience working with cross functional teams such as Regulatory, Clin Ops, Quality teamProfessional SummaryExtensively around 9 Plus years of pharmaceutical industry including CRO experience in both post marketing and clinical trials. Experience includes all aspects of serious adverse event case management and processing (receipt through SAE reconciliation and database lock), day-to-day vendor oversight, quality and compliance reviews, review of study narratives against source documents, and liaising with other functional areas for safety matterExpertise in Electronic Master File.Experienced in handling calls/email/faxes for Adverse event complaints, product quality complaints, Medical enquires and database and sort it to valid and invalid reports to process accordingly.Expertise in review and compilation and submitting of aggregate safety reports-PSURs, PADERs, 505(b)(2) and 505(b)(1) annual reports, and amendments, review 356H forms for completeness of dataProvide compliance update to senior management, experienced in performing non-compliance reports investigation.Experienced in authoring, and quality review of Aggregate reports such as PSUR, DSUR, and PADERS.Experienced in reviewing ASR reports, 356 h reports and BLA applications and cover letters.Experienced in submitting IND, NDA applications and amendments.Expertise in spontaneous, clinical, SUSAR, Legal, literature case coding and review, clinical narrative writing, quality compliance, quality assurance, and development and implementation of Global regulations/guidelines, Standard Operating Procedures (SOPs), and training materialsExpertise in medical coding using MedDRA and handling dechallenge and rechallenge scenariosComprehensive knowledge on clinical trials (Phase I-IV), pharmacovigilance principles and regulations.In Clinical Trial Cases used eTMF, stored the content of clinical trials, archived,Documented, knowledge of FDA regulation 21 CFR Part 11.Performed pharmacovigilance duties (Triage, Data entry, Case processing, Product Quality Complaints) for company products for submission to FDA, the European Agency for the evaluation of Medicinal Products (EMEA), and/or other regulatory authorities as requiredHandled Quality Assurance functions. Served as Quality Control team member to ensure that cases being submitted to the FDA were accurate and completePerformed Root Cause Analysis, deviation memo, CAPA, actively involved in SOP development.Proficient in data entry of case reports into ARGUS and ARISg safety databasesWell versed with the Reference Safety Information documents, data entry conventions and guidelines, clients procedures and international drug safety regulations including - ICH guidelines on safety and efficacy, FDA guidelines, CIOMS, US Code of Federal Regulations.Coordinated in project specific Safety Management Plan, reporting forms, further applicable project specific instructions and participate in study start-up and site training when applicable.Ability to work as an individual as well as part of a team, detail-oriented, flexible and self-motivatedAbility to prioritize, plan and organize work assignments and able to work under strict timelinesStrong organizational and timeline management skills.Highly creative, enthusiastic and dedicated team player with the ability to work well with minimal supervision. Excellent data entry skills, superior organizational, interpersonal, written and oral communication skills. Detail-oriented and focused on accuracy and efficiency. The ability to obtain a professional position, which will utilize my health care experience and skills that will provide me with an opportunity for professional and educational growth.Skill HighlightsExcellent telephone etiquetteHIPAA trainedExtensive medical terminology knowledgeAbbreviations comprehensionCounting and pouring expertiseInventory managementHospital and retail pharmacy professionalStrong decision-making abilityPharmaceutical storage awarenessStrong background in FDA drug safety guidelinesExceptional patient care and interactionExperienced in Oracle Argus safety systemSystem checks and troubleshootingComputer diagnostics and repairMac and PC expertComputer programmingHighly motivatedVirus and spyware removalDatabase maintenanceSpreadsheet managementMicrosoft Office proficiencyAdvanced MS Office Suite knowledgeExcelProfessional Experience:Sr Manager PV Operations & ComplianceNovavax, Remote Jan 2022-Till Date.Experienced in contributing towards PV Quality management systems such as ETQ Verse, Veeva quality, Trackwise systems.Performing PV oversight operations activities.Experience in performing, SIV, milestone tracking, EDL updates, close out activities pertaining to TMF and supporting inspection readiness activities.Experience in ICSR management and safety reports submission, root cause analysis for late submission and GAP analysis, Impact assessment.Experienced in CAPA Management, change controls, document management systems.Experienced in end-to-end PV change management. And compliance monitoring activities, such KPI reviews, late case investigation, over reporting of regulatory submissions investigation to applicable parties.Experienced in managing and monitoring training requirements upon change control completion and ensuring team is trained on new process as part of change control.Experienced in Vendor oversight for ICSR submissions and Pharmacovigilance aggregate report activities.Experienced in reviewing SUSARS, line listings, and aggregate reports and its quality review and work with cross functional teams to review and action on comments.Participate in aggregate reports Kick off meetings.Understanding of PSMF and its importance and regulatory obligations.Review PV vendor metrics on submission activities and track compliance, KPI monitoring.Played role as subject matter expert for MHRA, FDA audits and prepare for inspection readiness, also participated in inspections, internal audits.Understanding of PSMF regulations and contribution to PSMF drafts and approvals.Experienced in performed vendor oversight for Adverse event case management activities, literature monitoring with third party vendors.Contributed and preparation of aggregate safety reports (PADER, DSURS, PBRERs), quality review of the reports, and submission activities.Experienced in performing QC/review of safety surveillance plans and its management.Experienced in performing Pharmacovigilance risk management activities.Experienced in gathering opinion on process improvements to make sure team is comfortable with new process and ensure new process is easy to absorb and follow.Experienced in identifying SMEs for work on change control process.Served as SME for Pharmacovigilance eTMF compliance related activities across the company sponsored trials.Manager PV Operations Lead (Quality Management & Regulatory compliance activities)Moderna Therapeutics, Boston, MA (Remote based) Jun-2020- Dec 2022Leading and managing PV Operations activities across the company platform.Extensive experience with working cross functional team such as medical information team, product complaints team, regulatory team.Providing support to EU RMPS, Local RMPS,Supported REMS programs for shared REMS and opioid REMS contribution.Experienced in managing PV Quality management system and employee training management activities, such as onboarding training, recurrent trainings, on the job trainings.Experiencing in preparing training Matrix/RACI Martix.Experienced in working CAPAs, deviations, change control requestsExperienced in monitoring drug safety mailbox for incoming and outgoing mails and distributing emails to correcting group/responsible person for action. Liaison between regulatory and clinical teams for project related tasks.Experienced in providing support for health authority inspections, internal audits, mock inspections. Participated in audits as scribe, response receiver, review of audit responses.Experienced in working with Argus safety system and working with configuration team for latest RSI/IB import.Day to day usage and tracking of adverse event reports status in SharePoint and archival of submission/ack emails in the share point and saving all the communications in the SharePoint.Established successful working relationships with and provide oversight to PV Vendors/CROs with day-to-day PV operational activities for Modernas investigational products including but not limited to ICSR activities.Involved in performing email/fax/phone follow ups with HCPs, Investigators,Working with Immuno Oncology and infectious diseases products for company portfolio pharmacovigilance compliance activities.Experienced in involving inspection readiness activities for Emergency approval for drug usage.Assist with review and maintenance of Pharmacovigilance AgreementsDay to day activities involving Quality review of ICSRs processed by vendor and ensuring cases are processing on time and following SOPs and work instructions.Quality review of cases according to company specific QC checklist,Communicating QC findings with Vendor, and ensuring non-compliance was filed by vendor quality management systems and involved in impact assessment /analysis activities to document the findings.Review the corrective and preventive actions (CAPA) are measured properly and track effectiveness check as applicable for pharmacovigilance activities.Working with business partners for safety data exchange agreements (SDEA)to ensure other reports are shared with business partner on timely manner.Ensure overall performance of the department and compliance with global regulatory requirements by assisting in implementation of applicable SOPs, processes, metrics, and monitoring of performance and compliance.Responsible for implementing PV related activities within the scope of PV operations as outlined in relevant agreements with Business Partners and/or other parties, as requiredCollaborates with other key stakeholders to provide expertise and guidance for interdepartmental and cross-functional team activities, including process improvement standards and metrics.Liaises with financial / project management for budget planning.Provide Subject Matter expertise (SME) during audits and inspections in the areas of case processing/case management activities, literature monitoring, metrics, vendor oversight, etc.Pharmacovigilance Lead Specialist & Regulatory complianceSun Pharmaceuticals, Princeton, NJ Jan-2019- May-2020Experienced in handling calls/email/faxes for Adverse event complaints, product quality complaints, Medical enquires and database and sort it to valid and invalid reports to process accordingly.Day to day activities involved as quality review of ICSRs against the source documents, and submission activities and archiving receipts.Lead and manage PV activities across US products.Performing submissions for generic drugs to FDA.Assisted in reviewing PV agreements, SDEA safety data exchange agreements, and AE exchange to business partners according to timelines.Experienced in Vendor oversight for ICSR submissions and Pharmacovigilance aggregate report activites.Played role as subject matter expert for MHRA, FDA audits and prepare for inspection readiness.Experienced in performed vendor oversight for Adverse event case management activities, literature monitoring with third party vendors.Contributed and preparation of aggregate safety reports (PADER, DSURS), quality review of the reports, and submission activities.Experienced in performing Pharmacovigilance risk management activities.Participating in REMS meetings and manage the development, implementation and/or maintenance of REMSPerforming compliance monitoring activities to ensure all cases are submitting in a timely manner.Co-ordinating with Vendor regarding shared REMS, and REMS timelines and review documents and provides inputs in the weekly meetings.Experienced in ensuring all PADERs are submitting in a timely manner and communicate with cross function teams to confirm all the reports are updated according to guidelines.Timely escalate issues related to vendor performance, compliance and/or budget to ManagerEnsured timely execution of operational aspects of REMS and related activitiesExperienced in Review of all REMS related documentation and approve as requiredMonitoring external environment for regulatory changes impacting Pharmacovigilance and risk managementEnsuring audit preparedness and support regulatory inspections.Contributed to literature search activities to identify potential adverse events related to safety, and process and report them according to SOPs.Identify and lead process improvement activitiesManaged and handled regulatory submissions like periodic reports and annual safety reports.Experienced in using pharma ready tool for eCTD submissions and compilation and validation of regulatory reports and submitting reports to US FDA WEB TRADER system.Experienced in compiling and validating and publishing and submissions of PADERs, PSURs, annual safety reports.Day to day activities of reviewing and compiling annual, periodic reports and Amendments.Reviewing of annual, quarterly periodic safety reports.Assisting with performing follow ups for ADEs as required for serious cases of company products marketing in North America.Support training managementSupport compliance driven initiativesExperienced in using Medenquirer for process of intaking adverse events, PQCs, MIs of company products.Quality monitoring as CAPAs, Change controls as necessary.Authoring, and quality review of Aggregate reports such as PSUR, DSUR, and PADERS.Experienced in submitting IND, NDA applications and amendments.Drug Safety Case Manager II, (Johnson &Johnson-Horsham PA) Dec 2017 Dec 2018Regulatory Compliance Activities and case management,Ensure the timely submission of reports to worldwide regulatory agencies in accordance with applicable regulationsEnsure proper coding of AE terms into adverse event global database.Responsible for drafting and reviewing and compilation of aggregate reports such as PSUR, DSUR, PADERS,Extract adverse event data from various clinical trial cases and/or spontaneous sources.Experienced in working for Biological products for oncology and haematology and other therapeutic areasManage all case-related information including medical conditions, lab results and procedures as well as compile complete narrative summaries and queries.Review, enter and verify follow-up information from spontaneous sources and clinical investigations.Experienced in using SCEPTRE database for individual case safety processing.Experienced in data entering for patient medical history, drug history, concomitant drugs, suspect drugs.Experienced in MedRA coding of adverse events for all therapeutic areas.Involved in processing Solicited cases, spontaneous post marketing cases, clinical trial cases, literature reports.Experienced in working with adverse events associated with product quality complaints.Involved in daily-co suspect reports, ensuring if any new co -suspects reports are pending in the share point and querying case processor, or quality reviewer for solution if the company drug is coded to non-company drug,Experienced in monthly, biweekly, weekly compliance monitoring for ICSRS timelines.Experienced in submitting ICSRS to worldwide regulatory authorities.Experienced in reviewing RSI safety documents and labelling. Reviewing of company core data sheets (CCDS), USPI and IB labelling.Experienced in working with case report forms.Experienced in working with CAPA (corrective and preventive action) and protocol deviations, change control.Experienced in processing cases for biologics and company complex oncology products serious adverse events and involved in risk management activities.Experienced and performed activities of global Epidemiology with evidence-based practice by identifying risk factorsExperienced in signal detection activities and review risk management activities for the company products.Ensuring all co-suspect product related cases are created in the SCEPTER.Query generation to the responsible people regarding co-suspect report.Experienced in working with product quality complaint reports by using Track wise systems and ensuring if the product meet specifications or not by using batch numbers, test results with investigations.Experienced in searching PV agreements Documentation in PV agreements system, to ensure if the AE/SAE is companys responsibility or Business partner responsibility.Experienced in using Share point for tracking case status and other case related documents and activities.Covance Clinical Development Services Sep 2016 Dec 2017Pharmacovigilance Associate Carnegie Center, Princeton NJAssist in or complete per the Safety Management Plan (SMP) the processing of all adverse event reports from any source.Assist in producing queries of safety data for clients as appropriate.Assist in the generation and maintenance of the PV&DSS metrics.Review and update Informed Consent Forms (ICFs) using labelling identified from Investigators Brochure (IBs)Assist Data Management or clients on reconciliation of safety databases.Provide input for monthly status reports.Involved in daily SAE case processing, ESR case processing.Experienced in determining the SUSAR and NON SUSAR criteria by reviewing PTR reportPerformed Triage depends on protocol requirements, as per study guidelines.Experienced in ARGUS case processing, PEGA Star ESR case processing.Responsible submitting reports to Regulatory authorities, Ethic committees, WIRB submission, CIRB submission.Involved in preparing paper TMF, eTMF and uploading eTMF packages as per the study protocols.Experienced in reviewing study monitoring plans for studies pre-study, start-up-phase IVAssisted in preparing reports from SharePoint smart log tracker.Good knowledge of Electronic data capturing (EDC)system.Experienced in Query management to investigators and Query tracking.Involved in preparing Audit documents and critical issues finding and missing documents.Reviewing partner transmission reports (PTR) and investigator brochures (IB).Critical thinking and case assessment of case seriousness.Maintains a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.Experienced in working with CAPA (corrective and preventive action) and protocol deviations, change control.Possess knowledge of other procedural documents, e.g., SOPs, and how they impact safety.Build and maintain good PV&DSS relationships across functional units.Demonstrate role-specific Core Competencies on a consistent basis.Demonstrate company Values on a consistent basis.Experienced working as a SME (Subject matter expert) for expedited case safety reports and e TMF and TMF activities and processing for specific clients.Assist in the preparation of client meetings and liaise with clients where appropriate.Assist with the set-up of, and the provision of data to, Safety Committees/DSMBs.Any other duties as assigned by management.Pharmacovigilance Specialist / Pharmacovigilance Coordinator Jan 2015 Jun 2016Advancing Drugs Washington, DCElectronic file systems and maintained electronic and paper files.Planned meetings and prepared conference rooms. Dispersed incoming mail to correct recipients throughout the office.Made copies, sent faxes and handled all incoming and outgoing correspondence.Responsible for the coordination of activities in the Pharmacovigilance (PV) DepartmentResponsible for maintenance of safety files for the PV departmentCollect all Adverse Event information to begin and maintain SAE case files for each clinical trialVerify accuracy and completeness of safety event filesEnsure all PV safety files are adequately updatedMaintain all PV templates to facilitate compliance with Alexion's SOP's, FDA and EU regulation, and ICH guidelinesHandles and prepares all of PV's Statement of Work (SOW)Responsible for maintenance of safety files which serve as the foundation of the information required to make clinical PV decisions and appropriate submissions to regulatory authorities.Liaison for internal sources, Regulatory Affairs, Quality Assurance, Clinical Development, Commercial Operations, Project Management and Scientific disciplinesHands on experience in using Oracle clinical database management systemsInvolved in preparing individual case report input during MMT reviewResponsible for data management activities including identification of level terminologyInvolved in creating Aggregate report, AD- hoc reports,Involved in Risk based monitoring of Adverse events.reported safety adverse events per MedRA lower level TerminologyPharmacovigilance Specialist Jan 2014 - Dec 2014Amethyst Technologies - Baltimore, MDAdministrative support for the adverse event reports.Made copies, sent faxes and handled all incoming and outgoing correspondence and involved in paper submission of adverse eventsStrong knowledge of MedDRA coding for adverse events.Experienced in Oracle ARGUS safety system.Ability to work in a team environment, strong organization skills, detail oriented, meet tight deadlines, strong communication skills both verbal and written.Demonstrate computer proficiency, demonstrated initiative and accountability.Assisted in preparing aggregate reports like PSUR, DSUR, PAER.Worked in processing of individual case safety reports of clinical trial and solicited, and spontaneous.Clinical Safety Assistant Aug 2012 - Dec 2013Immunophotonics Columbia, MDServe as primary role for triage and quality control (QC) of individual case safety reports (ICSR) ensuring that cases are reviewed and completed in a timely manner in accordance with appropriate SOPs (standard operating procedures), study protocols and regulatory guidelinesPrepare and review queries to obtain critical or missing serious adverse events (SAE) information for appropriate medical assessment and case closureParticipate in preparation and drafting of ad-hoc and aggregate regulatory reports (DSUR and PSLL) and labelling support documentsReview and update Informed Consent Forms (ICFs) using labelling identified from Investigators Brochure (IBs)Ensures compliance with health authority regulations in all aspects of PV case processing and reportingContributes to regulatory responses, IBs, study protocols, case report form (CRFs), Clinical Study Reports (CSRs), and other documents as requiredCollaborates with team members on the development and implementation of PV standard operating procedures (SOPs) and working processes (WPDs)Manages electronic and hard copy document management, retrieval, and archiving of PV information including ICSRsReviews and reconciles SAE data between clinical and safety databaseAssist with data-lock reconciliations and ensure all cases are complete and all outstanding queries are resolved and closedInvolved in daily case processing and preparing metrics to ensure case is submitted in a timely manner.Liaise with clinical operations, regulatory affairs, clinical research organization (CRO) and data management groups regarding safety data collection and data reconciliationRemains informed of all appropriate current health authority regulations and guidanceResponsible for preparation and submission of NDA reports to the FDA as well as submitting IND reports to Regulatory Affairs.Assisting in the case handling of adverse event reportsData entry for all serious and non-serious cases and Clinical trialsEducation andTrainingMasters in biotechnology (M.Sc.) Bangalore University 2007 Bangalore, India.Bachelors in biotechnology (B.Sc.) Kakatiya University 2005 India.Certifications/Trainings:Project Management certified ProfessionalSix Sigma Certified ProfessionalDrug safety Trained professionalQuality Management systems trained.Therapeutic ExperienceImmuno therapy phase I to IV blinded study.Hemoglobin A1C with type II diabetes with cardiovascular adverse events (pre-study, study start up I to IV phases)Thrombotic vascular events.Hematology, Oncology-Pro State, Breast Cancer.Drug addictionImmunology and Dermatology(psoriasis).Experienced in Phase I-post mark marketingDrug Safety/Other systems experience1) Argus 6.0 and higher versions2) SCEPTRE3) Aris G version 6 and higher4) STAR Safety tracking and reporting5)Medenquirer Medical information and content Management system (used for Adverse event case intake, IRT system, Product quality complaints system)6) Pharma Ready Tool -For compilation and validation of Periodic safety and annual safety reports.7) Share point tracking system8) EtQ verse9) Trackwise Systems10) Zoho DOCS, Documentum document management systems |
