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Click here or scroll down to respond to this candidate55K Reading Road Phone: PHONE NUMBER AVAILABLEEdison, NJ Street Address E-mail: EMAIL AVAILABLECandidate's Name
QUALIFICATION SUMMARYProactive and strategic pharmacovigilance leader with significant pharmaceutical industry experience in areas of Vaccine, Drug/Medical Device Safety, Pharmacovigilance Operations, Compliance, Regulatory Affairs, Quality Risk Management. Expertise in aforementioned areas of more than 10 years, for both clinical trial products and post marketed vaccines, drugs/Medical Devices. In depth knowledge of US FDA, GxP areas including (cGMP, GCLP, and GCP), ICH, GvP, and EU PV regulations to bring a unique perspective and contribute to growth and strengthening of the pharmaceutical sector.CORE COMPETENCIES:Global Patient Safety Compliance and Pharmacovigilance experience: In-depth knowledge of US FDA, GvP, GxP areas including (cGMP, GCLP, and GCP), ICH and EU(EMA), UK(MHRA), Japan( PMDA) PV regulations and guidance documents governing both safety reporting and processing for clinical trials and post-marketing environment.Managing author and review of safety sections of safety documents including PBRER, PADERs, PSUR, SUSARs, DSUR, IBs, ICSRs, IND, NDAs, and Risk Management Plans (RMPs)4 years of management experience in PV required8 years of Drug Safety/Pharmacovigilance experience, including both investigational and marketed productsProject Management and People ManagementAbility to mentor, coach and guide to help others excel on the jobPreparing and responding to Regulatory Agency Inspections as well as internal and external auditsEnd to end Case Processing (Receipt, Triage, Data Entry, Assessment, Quality Review, Query Generation, Manufacturer Notification, and coding)Extensive knowledge of Adverse Event and drug coding conventions (MedDRA, WHO-DD)Knowledge of end user experience/configuration of safety databases (ARGUS safety system database)Opening and Investigating Quality Events, Deviations and CAPAProficient computer skills including Microsoft Word, Microsoft PowerPoint, and Microsoft ExcelEMPLOYMENT HISTORYPfizer Inc, Peapack, NJ, USA April 2021 April 2023Manager, Worldwide Safety and Regulatory Quality Control (Contract)Oversighted global Individual Case Safety Report (ICSR) collection, processing, and reporting in accordance with regulatory authority reporting requirements and Pfizers Standard Operating Procedures (SOPs)Oversighted workload distribution in coordination with Drug Safety Team Lead and Country Safety LeadsCollaborated with cross functional teams ( Case Processing, Quality/Compliance and Safety Systems management) to ensure efficient and compliant case processingLed the aggregation, trending, and analysis of case processing metrics, plus facilitated the discussion of metrics, trends, root causes of late submissions of case processing to identify areas for process improvementParticipated in the development/update of Standard Operating Procedures (SOPs), and Working Instructions (Wis), processes and practices for safety data handling in accordance with drug safety and pharmacovigilance regulations, ICH standards, guidelines, and industry best practices to ensure timely and compliant submissions to worldwide regulatory agenciesOversighted Pharmacovigilance(PV) vendor case management (submission timelines, quality deliverables, and compliance to regulations).Oversighted safety information processing, reconciliation, and reporting by outsourced vendors including review of ICSR and reviewed case processing metricsDeveloped and mentored resources regarding case processing, reporting and distribution of ICSR globallyDeveloped Key Performance Indicators (KPIs) dashboards, reports, and tools to track timeliness/ regulatory compliance of deliverables regarding case processingCollaborated with cross-functional teams to resolve late ICSR submissions by ensuring the development and implementation of strategies for case management process, Root Cause Analysis(RCA), Quality Event Investigation, and Corrective and Prevention Action (CAPA) and Deviation management implementationPrepared and responded to Regulatory Agency Inspections as well as internal and external auditsMonitored industry best practices, and changes in global safety regulations and guidelines for marketed and investigational products, and recommended changes and upgrades to existing department policies, and SOPsDeveloped, reviewed, and updated drug safety forms and templates, and harmonized with relevant clinical operations forms and templates (SAE data collection form, PADER template etc)Provided input on quality services and policies collaborating with Directors and Senior DirectorsEvaluated case management processes and procedures against outcomes to identify methods to improve efficiency, accuracy, and compliance with Pfizer and regulatory requirements. Encouraged continuous improvementBayer U.S. LLC, Whippany, NJ, USA October 2020 March 2021Senior Manager of Medical Device Safety, Pharmacovigilance (Contract)Conducted global Pharmacovigilance (PV) business processes and analyses/trends safety data sets related to product quality complaint handling, regulatory reporting and clinical development for Bayer medical devices and combination products worldwide.Provided counsel as Pharmacovigilance medical device subject matter expert to ensure that an effective vigilance, post-marketing surveillance (PMS) and trending systems are implemented and maintained in compliance with global requirements/laws. Worked cross-functionally to generate solutions and implement process standards consistent with device industry best practices and global regulationsProvided content input to Project teams for designing, planning, and conducting analyses of safety data for the assessment of medical device safety and performanceProvided review and input to device risk management documents, including hazard analysis, user risk assessments, human factors protocol, etc.Was responsible for the production and accuracy of medical device analysis, interpretation of results and content contributions to PMS and Vigilance activitiesAssisted in preparing and responding to Regulatory Agency Inspections as well as internal and external auditsIndependently reviewed vigilance data sets and prepared reports for submission to the Health Authorities under strict timelines and resolved respective queries regarding product safetyCovance Clinical Development Services (LabCorp), Princeton, NJ, USA August 2018 April 2020Drug Safety Associate (Contract)Triaged and assigned priority to incoming ICSR events and classified them according to regulatory reporting criteria.Evaluated cases for seriousness, relatedness, and expectedness according to the protocol, investigator brochure, and /or package insert.Provided review and input to device risk management documents, including hazard analysis, user risk assessments, human factors protocol, etc.Utilized Veeva Quality Vault, Microsoft Office 365, MS SharePoint, MS Project, Excel one Note, Smartsheet ARGUS software and MedDRA coding to process Adverse Events and Serious Adverse Event reports.Executed case assessment (review events, determine labeledness, identify co-manifestations, review coding, determine causality)Utilized MedDRA dictionary for coding clinical events and WHODRUG dictionary for coding medications.Prepared narratives, according to prepared template; processed cases from clinical trials and post-marketing productsSupported the submission and distribution of reports and relevant tracking of distribution of Follow-Up lettersConducted follow-ups to ascertain further information and or to obtain product samples for Adverse Event reportsMERCK Research Laboratories, Rahway, NJ, USA August 2016 August 2017Senior Manager Clinical Safety and Regulatory Analyst III (Contract)Authored safety sections of Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), SUSARs, PADERs, CCDS(CCSI), RSI, IBs, CSRs, NDAs, Addendum Reports and US Periodic Safety Reports (PSRs)Used ARGUS safety database, including implementation, migration, and reportingFacilitated the development and management of Pharmacovigilance System Master File (PSMF)Reviewed technical documents (both self-review and peer review) for data accuracy, consistency, correct use of grammar and consistency with the MERCK and regulatory authority guidelinesManaged safety signals for drug products, both those in development and marketed products, for the collection and identification of safety signals using data for signal surveillance activities, categorization, and prioritization of safety signalsVendor management oversight, and readying organization for Inspection PreparednessAssisted in preparing and responding to Regulatory Agency Inspections as well as internal and external auditsIdentified quality issues and recommended/approved changes, CAPA for manufacturing and compliance to ensure adherence to regulatory requirementsParticipated in aggregate activities involving exchange of adverse experience data with licensing partners involved with MERCK as part of clinical trial investigations, Pharmacovigilance Agreements(PVA), supply agreements, comarketing agreements divestitures and co-promotional agreementsSupported early and late phase development/drug developmentCollected, compiled, and monitored compliance and quality metricsBristol- Myers Squibb, Pennington, NJ, USA January 2016 - April 2016Senior Drug Safety Reviewer (Contract)Triaged and evaluated Individual Case Safety Reports (ICSRs) for report type, seriousness, causality, expectedness/labeling, and reportingEvaluated cases for seriousness, relatedness, and expectedness according to protocol, investigator brochure and/or package insertEntered case information and utilized ARGUS safety database, including configuration, implementation, migration, and reportingplus, MedDRA dictionary for coding clinical events and WHODRUG dictionary for coding medicationsWrote narratives summaries on assigned ICSRs, according to prepared template; processed approximately 20 cases per day from clinical trials and post-marketing productsRe-assessed pregnancy cases and off -label use of ICSRs for a Corrective and Prevention Action (CAPA) from a European Medicines Agency (EMA) auditAttached appropriate queries for missing/discrepant information and added follow-up letters as per Standard Operating ProceduresMonitored workflow status of adverse events reports in the safety database to ensure compliance with case processing timelinesJohnson & Johnson, Horsham, PA, USA April 2015 July 2015Drug Safety Associate (Contract)Triaged and evaluated Individual Case Safety Reports (ICSRs) for report type, seriousness, causality, expectedness/labeling, and reportingProcessed cases with accuracy and consistency at the various stages of the workflow system using ARGUSEvaluated processes and procedures against outcomes to identify methods to improve efficiency, accuracy, and compliancePerformed necessary follow-up for missing, discrepant, or additional information from source documentationPrepared clinical narrative summaries for Adverse Events reports independently from clinical studies and spontaneous post-marketing reportsDeveloped and maintained expertise knowledge for applicable corporate and global regulations, Standing Operating Procedures, Working Instructions, MedDRA coding dictionary and MedDRA points for data entry conventions and for such functions in the safety databaseCollaborated with key stakeholders for example Regulatory Authorities, Contract Research Organizations, Local Safety Officers and Marketing partners regarding Drug Safety data collection and data reconciliationMonitored workflow status of Adverse Event reports in the safety database to ensure compliance with regulatory authority processing timeline guidelinesAstraZeneca, New Jersey, USA April 2013 March 2015Drug Safety Associate (Contract)Triaged and assigned priority to incoming events and classified them according to regulatory reporting criteria. Evaluated cases for seriousness, relatedness, and expectedness according to the protocol, investigator brochure, and /or package insert.Executed case assessment (review events, determine labeledness, identify co-manifestations, review coding, determine causality)Utilized MedDRA dictionary for coding clinical events and WHODRUG dictionary for coding medications.Prepared and reviewed narratives, according to prepared template; processed cases from clinical trials and post-marketing productsGreenwich Clinical Commissioning Group a CRO, London, UK May 2007 September 2012Drug Safety and Pharmacovigilance Specialist (Full time)Reviewed Adverse Event (AE) and Serious Adverse Event (SAE) reports from development and/or post marketing sources to assure data accuracy, validated ICSRs assessments as per regulatory authority requirementsUtilized Oracle ARGUS software and MedDRA coding to process AE and SAE reportsAuthored and reviewed safety sections of Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), IBs, CCDS(CCSI), RSI, CSRs, NDAs, Addendum Reports and Periodic Safety Reports (PSRs)Provided oversight of Pharmacovigilance activities including vendor management, and ongoing processEDUCATIONBachelor of Pharmacy Degree, Jamia Hamdard University, New Delhi, INDIA.July 2005Master of Science (Public Health), London School of Hygiene and Tropical Medicine, University of LondonOngoing Online- expected completion date 2025 |
