PV Professional with Operations/Systems/Compliance
Resume:
Prasanna Ganta 617-***-**** ********.*******@*****.***
Skills
Clinical and Post-Marketing PV Operations setup
Deviation & CAPA Management
Database experience (Argus/IVP, ArisG, Oracle AERS)
Quality systems (TrackWise, Veeva) experience
Medidata RAVE EDC & RSG Gateway implementation
Inspection Readiness(FDA, EMA, Health Canada)
Regulatory Intelligence Tools experience (Tarius, Cortellis)
eTMF QC and filing (Veeva/ CRO eTMFs)
Safety Database and Medidata Rave integration
Signal Tools setup & Signal Management
PVAs/SDEA management
PV budget planning & analysis
Vendor / CRO Management
DSUR, PBRER, PADER authoring and submissions
CTD/CTR PV setup experience
Regulatory Authorities RTQ responses experience
SAE Reconciliation
PSMF development & maintenance
IB/Protocol/ICF authoring and review
CSR, RMP, REMS safety authoring and review
Education
MBA in Pharmaceutical Management,
Fairleigh Dickinson University, New Jersey
Bachelor of Pharmacy, JNTU India
Employment History
Arrowhead Pharmaceuticals Inc. Oct 2023 – Jul 2024
Director, Drug Safety Operations
•Mentor and Supervise Safety Operations and Science personnel and ensure flawless execution of Safety and Pharmacovigilance processes
•Lead activities related to implementing and maintaining the Safety Database, supporting ARGUS activities, Overseeing the Safety Vendors, and coordinating the Safety Reporting from Clinical Trials and Collaborators
•Provide drug safety case management support to medical monitors; assist in following up on queries for case reports, abnormal laboratory values, or any other relevant safety and medical data
•Support in quality assurance activities, including deviation reports and generating necessary CAPA to ensure Arrowhead is meeting all safety compliance requirements
•Manage Arrowhead's QMS for safety/Pharmacovigilance procedures
•Supervise the development and updating of Clinical Risk Management Plans for all clinical studies. Prepare and update study-specific Safety Monitoring Plans as needed
•Oversee compiling safety data required for DSC and DSMB meetings for Arrowhead clinical studies
•Supervise managing and updating safety surveillance procedures including signal detection review processes and monitoring abnormal trending of adverse events and laboratory results
•Oversee monitoring safety surveillance for Arrowhead's clinical development products to ensure corporate compliance with national and international adverse event reporting requirements
•Support the Head of Safety in the review and development of written materials including clinical trial protocols, Informed Consent Forms, Case Report Forms, adverse event (AE)/ serious adverse event (SAE) reporting forms, Clinical Study Reports, and Investigator's Brochures (including Reference Safety Information determinations)
•Oversee with preparation for regulatory inspections including a compiling of material relating to safety/pharmacovigilance reports and activities
Mirati Therapeutics Inc. Jan 2023 – Oct 2023
Associate Director, Pharmacovigilance
Mirati Therapeutics Inc. Jul 2021 – Jan 2023
Sr. Manager, Pharmacovigilance
Mirati Therapeutics Inc. Jul 2019 – Jun 2021
Manager, Pharmacovigilance
•Oversight of SAE collection, processing, initial triage, and assessment of completeness, consistency, and seriousness within established timeframes and in compliance with global regulatory requirements
•Manage AE/SAE reconciliation with appropriate CRO data management personnel and Mirati team members as applicable
•Maintenance of PV SOPs and Work Instructions, working with Mirati Quality Assurance
•Support preparation and distribution of IND Annual Reports/Development Safety Update Reports (DSURs)
•Support preparation and execution of safety data exchange agreements with licensing partners
•Oversight of Mirati PV team members, clinical research organizations (CROs), licensing partners, and investigator-sponsored trials (ISTs)
•Management of peer quality review of case entry in the Mirati safety database
•Support signal detection and risk management activities
•Support Medical Monitors and Clinical Scientists to perform monthly safety review
•Represent PV and Safety Risk Management Department as applicable
•Maintaining inspection readiness and participating in health authority inspections and internal audits
•Under the direction/review of senior PV staff, participate in other PV and Risk Management activities as necessary
Unicon Pharma Inc. / Shionogi Apr 2018 – Jun 2019
Safety Systems Associate (Contractor)
•Safety Information Manager for Global products, responsible to analyze data and conduct SMT meetings periodically
•Prepare data using PVQ tool and Argus CIOMS-II Line Listings and conduct signaling meetings Author PADER/PBRER reports, Quarterly and other renewal reports as required for Global products
•Organize data using Excel to create tables and charts to facilitate data analysis for aggregate data review
•Perform QC and review final aggregate reports in Veeva Vault system (MIND 2.0)
•Collaborate with the data management team for maintenance on EDC database (RAVE) and address any queries from Safety team
•Collaborate with the database hosting vendor to develop and implement system changes (e.g., product configuration, protocol configuration, user access changes, MedDRA and WHO-DD upgrades) as needed to support PSPV business needs
•Create and deliver standardized/consistent/accurate data retrievals from the safety database and/or Pharmacovigilance Query (PVQ) tool, both routine monthly reports and/or ad hoc queries, as requested by internal and external customers
•Identify and respond to issues concerning Argus and/or system-related query tools
•Provide overview training on the Argus safety database, MedDRA and WHO-DD to new PSPV staff; keep the team informed of systems-related changes that impact case operations
•Participate in database user guide updates to provide systems related input/advice
•Consult with database hosting vendor to ensure timely responses on Shionogi’s open incidents in accordance with work order(s)/service agreements
•Support internal audit/inspection activities
Unicon Pharma Inc. / Shionogi Jan 2017 - Apr 2018
Drug Safety Associate (Contractor)
•Participate in clinical team meetings supporting the Shionogi development portfolio as representative of Drug Safety, when needed
•Review literature citations weekly for appropriate reporting and collection of safety information for both marketed and development products
•Participate in internal and external training programs, meetings, and conferences to continually improve and build a knowledge base of product safety and risk management
•Ensure accurate transfer of information from initial and follow-up source documents for adverse event reports to appropriate fields within ARGUS; code adverse events using MedDRA, create narrative of the adverse events, and manage case reports within the ARGUS workflow to meet local and global regulatory timelines
•Process case-related information including interpretation of medical conditions, lab results, and procedures; ensuring proper coding of data into the global safety database
•When required, perform timely and accurate triage of adverse event reports, complaints, & inquiries from physicians, pharmacies, consumers, and sales reps
•Correspond and interface with CRO’s regarding collection of safety information for development products
•Assist with SAE reconciliation activities with internal departments and external partners as needed
•Ensure timely preparation & submission of reports to regulatory agencies in accordance with applicable regulations - including US PADER, IND Annual reports, and ASR reports
Unicon Pharma Inc./ Covance Jun 2016 – Jan 2017
Drug Safety Support Specialist (Contractor)
•Assist in the processing of expedited safety reports (ESRs). Maintenance of adverse event tracking systems
•Assist with the reporting of ESRs to clients, regulatory authorities, ethics committees, investigators, and Covance project personnel, if required, within study specified timelines
•Provide administrative support to PV&DSS personnel (e.g., word processing, proofreading, and editing correspondence/documents, mailings, filing, faxing, photocopying, and archiving)
•Ensure all incoming faxed Serious Adverse Event (SAE) reports are time stamped, logged into the departmental tracking application, and forwarded in a timely manner to the designated Drug Safety Associate (DSA)/Senior Drug Safety Associate (Sr. DSA)
•Where applicable, check the PV&DSS hotline mailbox regularly for reported SAEs and forward messages to the designated DSA)/Sr. DSA
•Assist in the maintenance of files regarding adverse event reporting requirements in all countries
•Work within the Standard Operating Procedure (SOP) system, including departmental Work Instructions (WIs)
•Ensure submission of client-related documents is sent to the client within designated timeframes (e.g., SAE reports, ESRs, Safety Management Plans (SMPs))
Unicon Pharma Inc. / AstraZeneca Mar 2015 – May 2016
PS Operations Safety Specialist (Contractor)
•Support Surveillance activities and the impact on individual case or group of cases can have on product labeling
•Supports Safety Surveillance, Safety Support - Compliance and Marketing Company and US Medical Affairs and the US Clinical Teams
•Responsible for special projects (i.e., DSURs, PSUR table preparation)
•Participate in the triage process for incoming documents to insure timely and effective medical and scientific evaluation of adverse event information
•Request follow-up information from consumers, and health care professionals and requests clarification from foreign affiliates according to specific report types using both global and local SOP timeframes
•Review adverse event documents prepared by the Patient Safety personnel for accuracy, completeness, and validity prior to submission to the FDA
•Enter and maintain accurate tracking system for all AE reports (CRIMSON/Jasper)
•Lead team in preparing, organizing, and reviewing tabulations for Regulatory reports
•Execute special database queries to prepare additional reports required by FDA for inclusion in US Periodic Safety Update Report (PSUR)/Development Safety Update Report (DSUR) submissions, and coordinates with other Regional Patient Safety groups to ensure that all report-related documents are acceptable for submissions to regulatory authorities
Tech Data Inc. / PPD Jan 2015 – Mar 2015
Safety Specialist (Contractor)
•Review literature articles and process adverse event reports from literature per project and FDA guidelines
•Responsible for adverse event (SAE/AE) triage, data entry into PPD owned or client provided adverse event database, review of entered cases for quality, consistency and accuracy, follow-up with reporter and/or associated HCP, tracking of reports, and reporting activities
•Code adverse event terms and write SAE narratives according to client’s request
•Effectively communicate with project team members, client contacts and adverse event reporters
•Supports in investigation, root cause, corrective and preventive actions related to internal and external PV associated CAPA findings
•Coordinate the timely collection of reasons for late adverse event reporting and corrective actions to prevent future late reporting from clinical, regulatory, and marketing for inclusion in safety reports to regulatory authorities
Internship
Business Analyst Healthcare
SPG America, NJ (Aug 2014- Dec 2014)
•Analyze business requirements, construct workflow charts and diagrams, study system capabilities, writing specifications. Define project requirements by identifying project milestones, phases, and elements, forming project team, and establishing project budget.
•Monitor project progress by tracking activity, resolving problems, publishing progress reports, recommending actions.
•Determine operational objectives by studying business functions, gathering information, evaluating output and formats.
Marketing/Business Development Manager
Fitness Technologies Inc. - NJ (Sep 2013-Dec 2014)
•Coordinated and participated in the 2014 International Consumer Electronics Show (CES).
•Boosted website traffic by 50% by creating an Integrated Social Media Strategy.
•Cultivated and managed relationships with Key Clients, Vendors and Customers.
•Defined and tracked campaign effectiveness and adjusted strategies accordingly.
•Reviewed and made recommendations to improve the existing supply chain.
•Directed and coordinated marketing activities and policies to promote products and services.
Marketing/ Business Development Consultant
Agile Science and Chemicals, NJ (Sep 2014 – Nov 2014)
•Directed and coordinated marketing activities and policies to promote products.
•Analyzed Business developments and monitored market trends.
•Analyzed third-party data and investigated new growth opportunities.
•Networked and interacted with local, national, and international associations to optimize industry connections.
Project Manager / Market-Research Analyst
FindCancerServices.com, NJ (Jun 2013 – Aug 2013)
•Conducted market research &, competitive analysis for distress screening tools
•Developed new Distress Screening Tool for cancer patients
•Lead project team of four in research and development of oral and written presentations
•Track, validate and evaluate E-Commerce style searchable database
Accounting Assistant, Connexions Data Inc., NJ (Dec 2012 – Jun 2013)
•Gather and enter client invoices into QuickBooks
•General administrative work alongside Accounting
•Communicate with clients to discuss payroll terms and conditions
•Provide support to client with payment and credit options
Grad Assistant, MKTG/MGMT/ISDS Dept.
FDU, NJ (Sep 2012-May 2014)
•Organized and coordinated annual Management Mentor Program
•Liaison between corporate mentors and students
•Conduct competitive research for new program implementation
•Worked on CMS for university website maintenance
Volunteer
President, Indian Cultural Experience, FDU Jun 2013 – Jun 2014
•Lead the team in organizing events and developing cultural relationships
•Function as an intermediary between the university and new incoming students
•Collecting feedback from the students and submitting suggestions to the university
Cultural Chair, Indian Cultural Experience, FDU May 2012-May 2013
•Collaborate with other university organizations to produce cultural events
•Implement innovative ideas to increase cultural awareness in the university
International Student Mentor, FDU
Aug 2013 – Dec 2013
•Guide and mentor students for personal development and academic skills
•Mentor them on their financial and educational difficulties
Student Staff, International Student Association, FDU Aug 2013 – Jun 2014
•Assist college students on off campus trips
•Assist Faculty staff with administrative duties
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