Summary
Overview
Work History
Education
Skills
Coreskillsandexpertise
Careerabstract
Timeline
Generic

PRAVEEN PANGA

Toronto,Canada

Summary

Dedicated and detail-oriented Pharmacovigilance and Coding Manager with in-depth knowledge and 11+ years hands-on experience in implementing drugs/device standards and processes. Comprehensive knowledge of international drug/device safety and pharmacovigilance principles and regulations (FDA/EMEA/Health Canada). Good leadership, analytical, problem-solving and time management skills. Strong knowledge of quality management procedures and compliance monitoring. In-depth knowledge of coding principles (MedDRA), submission criteria, regulatory timeline requirements, technical requirements, ICH guidelines, safety databases (Argus, ARISg) and clinical databases (Rave, Fusion). Proven experience in handling all types of Adverse Events/Drug reactions and Complaints in safety database, Including writing safety narratives as per regulatory standards for Drugs and Medical devices. Demonstrated ability in handling and implementation of SOPs, conducting quality investigations, performing qualitative and quantitative reconciliations and handling queries from Health authorities in a timely manner. Demonstrated ability to work with MS Office products such as Word, Excel, Access, and PowerPoint.

Overview

12
12
years of professional experience

Work History

Pharmacovigilance and Coding Manager

Axiom Real-Time Metrics
Toronto, Canada
05.2021 - Current
  • Served as the primary liaison for clinical Serious Adverse Events (SAEs), managing triage, prioritization, and comprehensive assessment processes to ensure timely and accurate reporting
  • Conducted quality reviews of pharmacovigilance documents, including aggregate reports, patient narratives, and other regulatory submissions, ensuring compliance with industry standards
  • Spearheaded the integration of the Argus safety database, enhancing pharmacovigilance processes and improving organizational capabilities
  • Refined clinical trial protocols by ensuring adherence to high scientific and clinical standards, regulatory requirements, and recommending protocol amendments as necessary
  • Contributed to the preparation and review of critical tables for the Investigator's Brochures, supporting accurate data presentation
  • Directed the development and submission of pivotal regulatory documents, including PBRERs, PSURs, DSURs, and progress reports, ensuring regulatory compliance and strategic oversight
  • Optimized workflow distribution to ensure timely and efficient completion of pharmacovigilance tasks, enhancing team productivity
  • Collaborated with the Regulatory Affairs team to review and maintain accurate trial registrations in the Clinical Trial Information System (CTIS) per EU Clinical Trial Regulation (CTR)
  • Conducted detailed Root Cause Analysis (RCA) and implemented Corrective and Preventative Actions (CAPA) for lateness or duplication cases, strengthening process integrity
  • Played a key role in staff development by delivering targeted training programs and acting as a resource for team members, fostering a culture of continuous learning
  • Supported Medical Monitors with eligibility verification, data integrity checks, and the identification of cases requiring medical review
  • Partnered with the Clinical Development Lead and Clinical Data Manager to address queries requiring medical oversight, ensuring alignment and prompt resolution
  • Led safety trend analysis initiatives to proactively identify and mitigate potential safety risks
  • Provided expertise in eCRF design, improving data collection and analysis processes to support robust clinical data management
  • Managed the client safety mailbox, ensuring meticulous tracking and timely responses to adverse event information and product complaints
  • Championed the development and implementation of robust quality improvement plans for pharmacovigilance projects, driving operational excellence and ensuring compliance with industry best practices

Drug Safety Associate | Data Analyst

Cognizant Technology Services
, India
01.2016 - 12.2017
  • Executed drug safety data management processes – a combination of case intake, triage, case entry, MedDRA coding, narrative writing as per regulatory format, peer review, conducting appropriate and timely follow-up on all ICSRs, report preparation and submission to regulatory authorities
  • Data entry, quality review and medical review of new ICSR or follow-up ICSR related to any medicinal products and devices in compliance with global regulations and compliance timelines
  • Ensured that appropriate ICSRs are reported to the local Regulatory Authority in a timely manner and in accordance with corporate and regulatory requirements
  • Performed MedDRA coding, causality, expectedness and listedness assessment and ICSR reportability
  • Supervision and coordination of standard work instruction (SWI), SOP’s and service level agreements (SLAs)
  • Performed root cause analysis (RCA)/CAPA of late/duplicate cases and inactivation from safety database
  • Responsible for developing and maintaining up to date knowledge for assigned drug/medical device responsibilities, regulatory authority regulations and internal processes and procedures
  • Reconciliations of adverse drug reports with medical information and other business partners
  • Supported the overall employee training as required for Pharmacovigilance for new and current employees

Drug Safety Associate | Senior Process Associate

Tata Consultancy Services
, India
05.2014 - 01.2016
  • Performed initial checks of adverse event forms, duplicate search, and creation of new cases in safety database
  • Requesting queries to safety personnel responsible for missing information
  • Maintained all documentation required in accordance with Tata Consultancy services internal procedures and regulatory requirements
  • Accountable for accurate data entry, quality review of individual case safety reports and writing case narratives as per regulatory format and timely delivery drug safety data with quality standards
  • Assess validity (Triage), evaluates AE data for completeness, accuracy and regulatory reportability, assess causality, labelling & process adverse event reports received from sites/reporters in safety database
  • Quality review of ICSR’s and assists with the workload of other Safety Specialists
  • Accountable for performing the appropriate clinical assessments adhering to SOPs/other controlled documents in liaison with Global Pharmacovigilance Department to ensure all safety guidelines and regulations
  • Mentored the newly joined associates on ICSR Case Processing/QC as per the Global PhV requirements
  • Adhered to Quality, Productivity and regulatory timelines and performed other related duties that were assigned
  • Expertly processed literature cases
  • Hoffmann-La Roche Limited

Drug Safety Associate

Bioclinica India Pvt. Ltd
, India
12.2012 - 05.2014
  • Manage the intake, triage, and processing of adverse event (AE) reports from various sources (clinical trials, post-marketing surveillance, and literature reviews)
  • Perform accurate data entry of AE cases into safety databases while maintaining data integrity and confidentiality
  • Evaluate, assess, and categorize the seriousness and expectedness of adverse events
  • Generate and submit individual case safety reports (ICSRs) to regulatory authorities and partners within established timelines

Education

MASTER OF SCIENCE - Pharmacology

JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY
India
01.2012

BACHELOR OF SCIENCE - Pharmacy

ACHARYA NAGARJUNA UNIVERSITY
India
01.2010

Skills

  • Pharmacovigilance
  • Safety Systems
  • Case Management
  • Report Generation & Documentation
  • Protocol/ IB Review
  • Expectedness Assessment
  • Information Dissemination
  • Study Protocol
  • eCRF Development
  • Medical Review
  • Research & Development
  • Global Regulatory Reporting
  • Quality Assurance
  • MS-Office
  • Relationship Management
  • Data Analysis
  • Leadership & Mentoring
  • Drug Safety Coordinator
  • Clinical expertise
  • Study documentation
  • Eligibility assessment
  • Clinical judgment

Coreskillsandexpertise

  • Pharmacovigilance
  • Safety Systems
  • Case Management
  • Report Generation & Documentation
  • Project Management
  • Expectedness Assessment
  • Information Dissemination
  • Study Protocol Implementation
  • Electronic File Management
  • Adobe Acrobat/Nitro PDF
  • Research & Development
  • Global Regulatory Reporting
  • Quality Assurance
  • MS-Office
  • Relationship Management
  • Data Analysis
  • Leadership & Mentoring
  • Drug Safety Coordinator

Careerabstract

Dedicated and detail-oriented Pharmacovigilance and Coding Manager with in-depth knowledge and 11+ years hands-on experience in implementing drugs/device standards and processes. Comprehensive knowledge of international drug/device safety and pharmacovigilance principles and regulations (FDA/EMEA/Health Canada). Good leadership, analytical, problem-solving and time management skills. Strong knowledge of quality management procedures and compliance monitoring. In-depth knowledge of coding principles (MedDRA), submission criteria, regulatory timeline requirements, technical requirements, ICH guidelines, safety databases (Argus, ARISg) and clinical databases (Rave, Fusion). Proven experience in handling all types of Adverse Events/Drug reactions and Complaints in safety database, Including writing safety narratives as per regulatory standards for Drugs and Medical devices. Demonstrated ability in handling and implementation of SOPs, conducting quality investigations, performing qualitative and quantitative reconciliations and handling queries from Health authorities in a timely manner. Demonstrated ability to work with MS Office products such as Word, Excel, Access, and PowerPoint.

Timeline

Pharmacovigilance and Coding Manager

Axiom Real-Time Metrics
05.2021 - Current

Drug Safety Associate | Data Analyst

Cognizant Technology Services
01.2016 - 12.2017

Drug Safety Associate | Senior Process Associate

Tata Consultancy Services
05.2014 - 01.2016

Drug Safety Associate

Bioclinica India Pvt. Ltd
12.2012 - 05.2014

MASTER OF SCIENCE - Pharmacology

JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY

BACHELOR OF SCIENCE - Pharmacy

ACHARYA NAGARJUNA UNIVERSITY

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