Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Dr. Deepti Velampudi

Aldie

Summary

Physician functioning in pharma industry for 7 years with Pharmacovigilance experience. Reviewing and approving appropriate selection of adverse events (AE) from source documents, assigning appropriate coding for AES, medical history and concomitant medications with MedDRA and WHO-Drug dictionaries. Verifying the determined seriousness of the case Performing or review of ICSR case assessment including listedness/ expectedness, of the Adverse events with Reference Safety Information (IB, CCDS, SmPC, USPI) Oversight of medical review cases done by vendor and providing inputs on assessment and medical evaluation comment Providing medical safety input, and reviewing or drafting sections of response documents to health authority inquiries, as appropriate. Identifying, reviewing and un-blinding (If applicable) SUSAR cases Reviewed aggregate safety data to provide medical input into aggregate safety reports such as PBRER, DSUR, PSUR, PADER. Experience in Signal management activities with expertise in authoring signal evaluation reports and recommending next steps of action to senior management. Experience in review of clinical trial protocol, CRFs, Investigator’s brochures, Informed consent forms and CSR Maintaining an excellent knowledge profile of assigned drugs, Reviewing and updating RSI documents on safety database Liaise with Medical Monitor for co-ordination and reconciliation of Immediately Reportable Events (IREs) between site and Safety Team. Supported global clinical development, medical affairs, data sciences and regulatory activities as the pharmacovigilance representative. Proficient in Safety databases such as ARGUS, ARISg, Rave, Rave-X, Jarvis, Veeva Vault, CDOD, Empirica, etc High level of understanding of applicable regulations, including FDA (21CFR 312 and 314), ICH (E2A, E2B, E2C), GCP guidelines, EMA regulations, GVP Modules, etc. Mentoring and training new staff as required for overall understanding and compliance of the company.

Dedicated healthcare professional with strong foundation in pharmacovigilance and patient safety. Proven ability to assess and mitigate drug-related risks, ensuring compliance with regulatory standards. Known for fostering team collaboration and delivering reliable outcomes in dynamic settings.

Overview

10
10
years of professional experience
1
1
Certification

Work History

Drug Safety Physician

Catalyst Pharmaceuticals
01.2024 - Current
  • Performing in-depth sponsor review of all serious and non-serious adverse events outsourced to our PV vendor, specifically the assessment of seriousness, causality, and expectedness of the adverse events in reference to the RSI of the product
  • Responsible for the medical review of all safety data throughout the life cycle for Catalyst product(s)
  • Schedule meetings with the PV vendor and provide feedback on case quality and compliance
  • Ensure the timely submission of Adverse Events and notification of our marketing partners through our PV vendor
  • Reconcile adverse events with clinical database for IND studies and review DSUR for completeness
  • Performing reconciliation with business partners and vendors for AE report exchanges
  • Assist in safety signal surveillance and aggregate data analysis for Catalyst products on an ongoing basis
  • Support and collaborate with cross-functional teams on safety-related activities
  • Perform medical oversight including vendor oversight on ICSRs, narratives, literature review, signal evaluation, and aggregate reports to ensure accuracy and completeness of the safety content
  • In collaboration with the PV Vendor, collaborate in signal management activities (i.e., signal tracking, evaluating safety data, review meetings, etc.) for assigned products
  • Compose Individual Case Safety Report (ICSR) Company causality and Company Comment by using medical expertise, clinical and medical judgement, analyzing the adverse events, and appropriate Reference Safety Information (IB, CCDS, SmPC, USPI)
  • Perform medical review of cases including narrative content, queries, MedDRA coding, expectedness, seriousness, causality, relatedness, and company summary
  • Maintain the management and processing of all ICSR adverse events reports ensuring all cases are processed and reported quickly within required timelines with top quality
  • Maintain PV vendor oversight
  • Provide responses to triage, data entry, and medical review responses received from vendor
  • Team leader and mentor fellow Drug Safety Physicians
  • Responsible for their management and professional development
  • Provide medical safety input, compose sections of response documents to health authority inquiries
  • Provide ICSR safety narratives, medical safety input to supplemental NDA (sNDA) to Regulatory Health Authority
  • Review and update Reference Safety Information (RSI) documents including product label and Investigator Brochure (IB)
  • Implemented, developed, and lead the signal detection process for Catalyst products including signal detection escalation evaluation, and recommendations for next steps of action
  • Support decision making through risk benefit evaluations and medical data analysis
  • Author Adverse Event of Special Interest Report (AESI) to fulfil company obligation to Regulatory Health Authority
  • Manage Catalyst products local and global Literature Search
  • Collaborate and work closely with the clinical team to review clinical trial safety protocols
  • Work closely with the clinical team to collaborate information to update Catalyst Pharmaceuticals Products Investigator Brochure (IB)
  • Represent the PV team in cross-safety and cross-functional forums, effectively communicating processes and specific project outcomes
  • Review the safety portion of Aggregate Reports such as PADERs, DSURs, and PSURs for completeness of safety information
  • Oversee the Pharmacovigilance process of the Aggregate Reports such as organizing the kickoff meeting, managing signal activities, regulatory requests, literature reviews, and studies undertakings
  • Reconcile adverse events with safety databases
  • Author and modify Safety Operating Procedures (SOPs) and Work Instructions
  • Participate in FDA and Business Partner audits, inspections, and maintain compliance with Regulatory regulations
  • Ensure product complaints are separated from AE reports
  • Initiate, maintain, and close Corrective Action Preventative Action (CAPAs) as needed
  • Develop training material and train PV vendor
  • Use of safety database ARGUS, Veeva Vault

Manager, PV Safety Analysis Scientist

GSSRM (Global Safety Strategy Risk Management), J&J
01.2022 - 12.2024
  • Independently working to expand and apply clinical and pharma knowledge to manage the safety surveillance for assigned products in consultation with the Lead MSO
  • Work with MSO on strategy development and analyze the appropriate data to investigate safety issues
  • Collaborate with Therapeutic Area Safety Head (TASH)/MSO/Safety Surveillance Physician (SSP) and other stakeholders on managing and preparing strategy for regulatory documents and responses to safety inquiries from regulatory agencies
  • Work actively in initiating, overseeing safety data and assisting the MSO in leading the Safety Management Team (SMT) meetings
  • Worked in multiple Tas: Including Vaccine Development and Research (Covid-19 Team) and Heme-Malignancies TA
  • Responsible for core safety deliverables including scheduled and ad-hoc aggregate reports
  • Co-author and review core safety aggregate reports such as PBRER, DSUR
  • Review and provide safety input to submission documents (Summary of Clinical Safety, Protocol amendment, cRMP, CCDS, USPI, EUPI, IB) including ADR section
  • Responsible for daily activities in planning, conducting meetings, aggregate safety analysis and case level review, writing and project management coordination of strategic safety documents
  • Recognize potential issues and or safety issues and escalate to the attention of the product safety lead
  • Ensure safety commitments (eg
  • Assessment reports) are met
  • Provided scientific expertise and leads the safety assessment of assigned products
  • Lead safety evaluations, including strategy discussions, collaborating with Therapeutic Area Safety Head (TASH)/MSO and other collaborators as necessary, data retrieval, data analysis, report writing, and report revision
  • Demonstrates knowledge in PV Reports, Safety Views
  • Ensured high quality safety evaluations and reports with minimal-to-moderate comments from collaborators and minimal-to-moderate revisions which were required
  • Provide support to AD SASs for novel projects without defined processes
  • Provide input and review to key regulatory or clinical documents as appropriate
  • Lead proactive safety data reviews and form a safety position across GMS which can be used for aggregate safety reports
  • Provide support for Health Authority interactions regarding safety and risk management, both written and verbal
  • Works closely with the safety physician to analyze potential safety issues, including signal detection, signal evaluation and signal management
  • Collaborates proactively with study teams, cross-functional team members, external business partners and vendors to apply knowledge and analytical skills to problems in specific therapeutic areas
  • Contribute to signaling and data mining activities utilizing internal and external sources of data
  • Performs signaling data review from all sources including but not limited to: Empirica, Clinical and Safety outputs, Literature, and HA requests
  • Responsible for evaluation and development of Safety Management Plans
  • Develop knowledge of capabilities and limitations of various data sources
  • Assist in the evaluation of potential safety issues and quality risk assessment reports
  • Contribute to activities related to the functioning of company safety committees, including but not limited to, preparing reports, minutes and meeting documents; ensuring completion of action items; and, participating in the discussion of patient safety issues
  • Contributes to the development of SOPs, work practices and guidelines, forms and templates, and other communications related to risk management and product safety
  • Responsible for ensuring the global team can anticipate, develop and support improved/consistent scientific ways of working to implement effective Patient Safety and Risk Management processes
  • Contribute as a member of the Drug Safety team to scenario planning, strategy analysis, budget management and forecasting
  • Manage and support the authoring for aggregate safety reports (eg.PSUR, DSUR, Line listings) in close collaboration with the safety product lead and operational functions

Medical Reviewer

AbbVie Pharmaceuticals
01.2021 - 02.2022
  • Provides medical expertise and judgement throughout the case handling process with medical review of ICSRs and cumulative line listing (aggregate safety data)
  • Contributes to, reviews, and supports development of safety sections for clinical IB, risk profiles, protocols, and regulatory reports (eg
  • DSUR, IND Annual reports, clinical study reports)
  • Performed signaling activities including review of medical/scientific literature, and contributed to safety surveillance process, including the identification of safety observations, emergent safety concerns and new safety signals and ensure prompt assessment and communication of confirmed safety signals
  • Performs continuous safety assessment, evaluation, and risk management activities of products in clinical development
  • Worked first hand with physicians and HCPs, experienced with KOLs and creating slides for data review (slide decks)
  • Prepares written medical analyses of important or evolving safety issues, utilizing clinical data from the safety and clinical databases, as necessary
  • Identifies safety issues that require further evaluations: including medical monitoring activities such as aggregate review data, inclusion/exclusion criteria, looking for trends/outliers, findings, any issues in data, etc
  • Use of Excel to make data easier to comprehend and analyze data using pivot tables, VLOOKUP
  • Evaluates clinical implications of safety data from the pre-clinical studies, clinical studies, literature, and other information sources in order to predict/establish the safety profile of study compound in clinical development to manage the risk to subjects
  • Review of patient data, AEs, SAEs, line listings, protocol deviations, review of labs, imaging, medications, etc
  • Experienced in promotional review, along with collaboration in medical affairs, in medical review, and regulatory updates
  • Perform medical review and clarification of trial-related AEs and post marketing ADR’s including narrative content, queries, coding, expectedness, seriousness, causality and company summary
  • Compose, edit, and medically review AOSEs for expedited cases as per Regulatory requirements
  • Provide aggregate reviews of safety information, including clinical data, to maintain oversight of a product’s safety profile
  • Represent and present safety and clinical data review findings during study meetings and medical safety team meetings
  • Medical Review and QC of IDRP’s, involving in-house review of Case Report Forms (CRFs) including query resolution and addenda writing, QA of data listings
  • Query generation and Review using Safety Database Rave, Rave X, Jarvis and Tesla Dashboards
  • Writing medical narratives associated with the subjects CRF
  • Taken part of investigator meetings on safety issues, responsible for serious adverse events and CRF completion, writing study summaries, and review protocols, study summary investigator brochures and IND annual updates for safety data verification
  • Provides medical escalation to the investigative site monitors as needed
  • Provided medical review and edits to the Safety aspect of the IND Annual reports, Aggregate reports
  • Worked with cross functional teams for interim database lock
  • Performed IDRP checks for studies using Spotfire and Jarvis systems in a timely fashion
  • Done periodic reviews of the Safety Review Plan (SRPs)
  • Reviewed and analyzed lab data and filed DSR (Data Safety Reports) for assigned studies
  • Communicate and interact effectively within and across the therapeutic teams, and within the functional team management, as appropriate

Drug Safety Physician

Otsuka Pharmaceuticals
11.2018 - 01.2021
  • Represent medical safety in cross functional teams in preparing global development and commercialization strategy plan and in interaction with Health Authority, provide medical input in clinical study initiation and assisted strategic decision making based on benefit-risk analysis in the development of investigational compounds
  • Serve as a program level safety physician and perform medical monitoring for clinical trials in conjunction with clinical development and CRO
  • Lead/ develop strategies for safety-related regulatory activities and provide medical review and interpretation of safety data for preparation of documents including study protocols, ICFs, IBs, CSRs, Company Core Safety Information (CCSI), DSURs and PSUR
  • Work closely with clinical operation and CROs in conduct of clinical trials and ensure timely report and accurate data collection
  • Counted as core clinical team member in query and follow up AEs and related study information as needed
  • Perform SAE reconciliation on a periodic basis and at DLP
  • Performed appropriate clinical assessments and ensured compliance with global regulatory reporting requirements
  • Utilizes knowledge of specific work practices, Standard Operating Procedures (SOP), and regulations in order to maintain oversight of vendor activities to ensure successful execution of tasks
  • Demonstrated computer literacy, with proficiency in the use and management of safety databases, including the client Global Safety Database, and Argus Safety
  • Ability to achieve personal objectives while meeting departmental standards of performance
  • Partner with the Head of Global Safety to escalate detected signals and patterns to leadership with recommended next steps
  • Prepare safety response letters and medical to medical communications together with Medical Affairs clinicians and the Medical Safety Officer
  • Participate with cross-functional teams involved in the development or support of products including research and development, quality engineering, medical affairs, clinical research, regulatory affairs and quality assurance
  • Demonstrated knowledge and familiarity with medical terminology
  • Acts as a clinical resource to department care coordinators, providing expertise and clinical support

Clinical Safety Reviewer

Mallinckrodt Pharmaceuticals
02.2016 - 10.2018
  • Medical review of individual case safety reports including performing coding and expectedness/listedness of the Adverse events with reference safety documents (IB, CCDS, SmPC, USPI)
  • Identify and review SUSAR cases (Un-blinding process if required)
  • Involve in review of data base outputs for identification of safety signals and managing/ facilitating team discussions for validation of any such signal
  • Supporting and facilitating for aggregate report preparation involved in creation of ASRs (PSURs, DSURs and PBRERs)
  • Contribute to Safety Meetings and Joint Safety Meetings by providing case summaries from Post-Marketing and Clinical Trial Cases
  • Determined the reportability of cases to local and international regulatory authorities and submission of cases in a timely manner
  • Filing PQCs (Product Quality Complaints) associated with adverse events
  • Setting up follow-up to the reporter for clarification and to collect all relevant safety data
  • Perform reviewing of narratives for medical coherence and also providing comments in accordance with company’s requirements
  • Perform Compiling, Reviewing and Quality Check of Individual Case Safety Reports (ICSR) for serious adverse events (SAE) and non-serious adverse events for completeness, consistency, accuracy and clarity
  • Updating data sheets for upload to safety database as per current RSI updates
  • Work closely in co-ordination with other departments in proper gathering, evaluation, medical assessment and follow-up of individual case safety reports
  • Identify and analyze trends and concerns with company products including the identification and evaluation of safety signals through the assessment of single case safety reports
  • Communicating and interacting effectively within and across all therapeutic teams, and within functional team management as appropriate
  • Performing any other drug safety related activities as assigned; Mentoring team members and assisting with the preparation of relevant training material
  • Demonstrates working knowledge of and coaches’ others in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with the Code of Federal Regulations (CFRs) and applicable Standard Operating Procedures (SOPs)
  • Attends investigator and coordinator meetings representing the Device / Drug Safety Information (DSI) functional group
  • Participates in or is responsible for reconciliation of device/drug safety databases and clinical study databases for adverse event reporting and tally
  • This includes evaluating the clinical database for non-site reported adverse events and their follow-up

Resident Doctor

Apollo Hospitals
11.2014 - 07.2015
  • Responsible for clinical diagnoses and treatments of various diseases in the ICU, ER, and the Out-patient medical care unit
  • Performed multiple surgical procedures for admitted patients, including general and life-intervening procedures
  • Highly experienced in emergency medical administration and medical care
  • Advised patients and responded to their queries related to health and treatment
  • Prepared and maintained accurate documentation in the EMR system
  • Managed inbound patient referrals as needed and liaised with other members of medical team
  • Certified in BLS, ACLS, PALS, and NALS

Education

Bachelor of medicine & Bachelor of Surgery (MBBS) -

01.2013

Skills

  • AE
  • SAE
  • SUSAR Review
  • MedDRA Coding
  • SMQ
  • Microsoft Office Suite
  • Signal detection activities
  • Clinical R Phase I to IV
  • Risk Management Plans
  • WHODD Coding
  • PV Audits
  • Inspections
  • Cross-functional collaboration
  • Benefit-risk evaluation
  • PSURS
  • PBRERS
  • DSUR
  • PADER
  • Aggregate
  • Periodic Report
  • ICSR Medical safety review
  • Labeling
  • IB
  • USPI
  • SmPC
  • CCDS
  • PV SOPs
  • Post-authorization safety studies
  • Quantitative Data analysis
  • Assess Causality
  • Expectedness
  • Excellent communication
  • Literature review using OVID
  • Vendor Management
  • Aggregate Reporting
  • Oracle Argus Safety
  • ArisG safety databases
  • Medidata Rave
  • Jarvis Safety Database
  • RaveX Database
  • SharePoint
  • Identifying ADR’s
  • Side effects
  • Medical charting
  • Monitoring
  • Understanding of ICH-GCP
  • HIPAA guidelines
  • Meticulous
  • Diligent
  • Methodical

Certification

  • Certified MedDRA Coder, 2015
  • Certified MedDRA Coder, 2021
  • DIA Pharmacovigilance certificate, 2014
  • CCRP-Certified Clinical Research Professional -SOCRA, 2013
  • CITI IRB research certification, 2013

Timeline

Drug Safety Physician

Catalyst Pharmaceuticals
01.2024 - Current

Manager, PV Safety Analysis Scientist

GSSRM (Global Safety Strategy Risk Management), J&J
01.2022 - 12.2024

Medical Reviewer

AbbVie Pharmaceuticals
01.2021 - 02.2022

Drug Safety Physician

Otsuka Pharmaceuticals
11.2018 - 01.2021

Clinical Safety Reviewer

Mallinckrodt Pharmaceuticals
02.2016 - 10.2018

Resident Doctor

Apollo Hospitals
11.2014 - 07.2015

Bachelor of medicine & Bachelor of Surgery (MBBS) -

Similar Profiles

CREATE PROFILE
Dr. Deepti Velampudi