Gopalu UmaMaheswar Reddy
Bangalore
Summary
Over eleven years of experience in pharmacovigilance with a focus on vendor management and leadership in aggregate reporting and ICSR case management. Expertise includes ICSR case processing, literature monitoring, and serving as a subject matter expert for RMPs and PADERS. Demonstrated success as the primary contact for audits and inspections related to pharmacovigilance services. Completed a six-month project management course from Indian Institute of Technology-Guwahati and holds PMP certification from PMI @ February 2026.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Sr.QA Analyst
Vantive (Payroll: Rangam Infotech)
Bangalore
05.2025 - Current
- Performance Monitoring: Monitor vendor performance through key performance indicators (KPIs) such as delivery times (TAT), Quality and regulatory compliance.
- Supported global drug safety by facilitating study sites with editable SAERF forms for AE reporting and reconciliations.
- Managed case processing and literature trackers, ensuring metrics were updated consistently.
- Reviewed and approved case nullifications, SUSAR cases, and addressed ad-hoc requests (case corrections and queries).
- Training Vendor employees and certified as applicable both Literature and Non-Literature case processing.
- Internal and external reconciliation as applicable in SDEAs.
- Literature email box including, Client review of abstracts, bulk completion, order FTA and copyright whenever is required. Also handling EU MLM for registered products.
- Order and provide FTAs as required using RightFind.
Deputy General Manager-Pharmacovigilance Services
Accenture
Bangalore
10.2024 - 03.2025
- Managed safety pharmacovigilance project operations to ensure compliance and efficiency.
- Managed inquiries related to RMP during safety and risk management audits and inspections, ensuring clarity and compliance.
- Led project to ensure compliance with SOWs and SLAs, facilitating timely delivery of pharmacovigilance services.
- Authored EU risk management plans (RMP) and Non-EU RMPs for assigned reports.
- Prepared RMPs encompassing risk characterization, pharmacovigilance activities, and risk minimization strategies to support regulatory compliance.
- Ensure that RMPs align with the product’s lifecycle, from pre-marketing through post-marketing surveillance.
- Ensure that the RMP addresses real-world data, post-marketing adverse events, and the effectiveness of risk minimization activities.
- Ensure RMPs and associated documents are prepared and submitted in accordance with regional regulatory agencies' requirements, such as EMA (European Medicines Agency), FDA, and others.
Safety Aggregate Report Specialist II
IQVIA Pvt Ltd
Kochi
02.2024 - 10.2024
- Drafted and maintained EU RMPs in compliance with EMA guidance, ensuring comprehensive safety specification, pharmacovigilance plan, and risk-minimisation plan.
- Authoring of EU risk management plans (RMP) and Non-EU RMPs for assigned reports.
- Coordinated with relevant stakeholders to ensure timely receipt, analysis, and incorporation of information into Aggregate Reports per regulatory requirements.
- Ensure RMPs include accurate characterization of important identified risks, important potential risks, and missing information, supported by scientific evidence
- Monitor the report timelines and ensure the reports were submitted within the SLAs and KPI.
- Identified and addressed gaps in data and information, collaborating with colleagues to enhance completeness of reports.
- Prepared updates to the RMP upon receipt of new safety information.
Senior PV Professional
Teva Pharmaceuticals
Bangalore
07.2021 - 01.2024
- Oversaw end-to-end lifecycle of PADER creation, ensuring accurate data extraction, narrative writing, quality control, and final approval.
- Lead, coach, and mentor a team of PADER authors, reviewers, and coordinators.
- Managed resource allocation, balanced workloads, and planned capacity to optimize team performance.
- Conduct regular performance reviews, provide actionable feedback, and drive professional development.
- Manage tracking of deliverables, metrics, KPIs, and milestones.
- Coordinated with safety surveillance, signal management, regulatory affairs, clinical, biostatistics, and IT to streamline PADER processes.
- Liaise with safety database teams for correct extraction of AE/SAE listings and compliance checks.
Aggregate Report Specialist I
IQVIA Pvt Ltd
Bangalore
09.2018 - 06.2021
- Collaborated with line manager to generate aggregate reports and support pharmacovigilance activities, enhancing data integrity.
- Executed quality reviews of line listings for PBRERs, PADERS, and six-monthly reports.
- Monitored progress on Argus report completion to meet deadlines.
- Coordinated with functional groups, including regulatory affairs and clinical operations, to streamline report preparation and facilitate communication.
- Developed responses to inquiries from regulatory agencies as needed.
- Performed literature safety surveillance for both marketed and investigational products.
- Attended planning meetings ahead of aggregate safety report initiation.
Senior PV Specialist
APCER Life Sciences
New Delhi
12.2016 - 08.2018
- Lead and manage the project.
- Record, maintain and track the metrics for both team members and project performance.
- Review and evaluate AE case information to determine required action based on and following internal policies and procedures.
- Process current incoming cases in order to meet timelines.
- Followed up on reconciliation discrepancies and outstanding queries to ensure adherence to departmental AE workflow.
- Documented process errors to facilitate continuous improvement and compliance.
- Train and mentor new team members as per requirements of the project.
- Identify and resolve issues and conflicts within the project team.
- Delegate tasks and responsibilities to appropriate personnel.
- Provided guidance and support to team members in their roles.
- Support PM in performing root cause analysis of failed cases.
- Provided updates on process efficiency and compliance improvements to enhance team awareness and drive action.
Safety Process Expert
Accenture Solutions Pvt Ltd
Chennai
10.2015 - 12.2016
- As Case Intake Member: Manages mailbox as assigned. Receive source data from client-specified sources (e.g., eFax, email, CIOMS from).
- Review source documents, check for minimum safety information, duplicate check of cases.
- Checked case for initial seriousness assessment in LAM.
- Prioritized cases based on assessed seriousness, causality, and labeling.
- Created action items for LPOs and team members.
- Processing of ICSRs (individual case study reports) including Post marketing/Spontaneous, solicited cases.
- Enter the data from source document to all relevant fields in Argus.
- Coding of suspect drugs using company dictionary and WHO DD for co-suspect, concomitant, historical and treatment medications.
- MedDRA specialist for coding Adverse events, current and historical conditions.
- Wrote medically relevant safety narratives for cases and checked the completeness of data entered in various fields.
- Supported development of Safety Management Plans (SMPs), Standard Operating Procedures (SOPs), and other procedural documents.
- Management of bolus case processing, non-case processing and SAE reconciliation.
Clinical Data Co-Coordinator
Quintiles Pvt Ltd
12.2014 - 10.2015
- Managed Medidata Rave database operations to support clinical trial data management.
- Oversee data-management lifecycle of large clinical trials, composing and verifying reports and results.
- Collaborated with study teams, investigators, and external vendors to ensure timely and accurate data collection and entry.
- Clarified and resolved data discrepancies to ensure data integrity.
- Executed data management tasks during startup, conduct, and closure phases to streamline processes.
- Work closely with Medi data Rave and Clinical developers on the design, testing and implementation of study databases.
- Managed ongoing communication to optimize cooperation between clinical teams and external partners.
- Ensured meticulous verification of data entries to uphold the quality of clinical trial outcomes.”],
Education
Professional Certificate Program In Project Management - Project Management
Indian Institute of Technology
Guwahati11-2025
M. Pharmacy - Pharmaceutics
Seven Hills College of Pharmacy
Tirupati, Andhra Pradesh01-2013
B. Pharmacy - Pharmaceutical Sciences
Annamacharya College of Pharmacy
India01-2011
Intermediate -
Board Of Intermediate
Andhra Pradesh01-2006
SSC -
Board of Secondary Education
Andhra Pradesh01-2004
Skills
- Pharmacovigilance Manager
- Team lead for Aggregate Reporting (PBRER and PADER) and RMP Manager
- ICSR Case Processing- Clinical Trials, Spontaneous and Literature Cases
- Literature Review (Including EU MLM)
- Vendor Management
- Performance monitoring
- Regulatory compliance
- Project Management
IITG-Professional Certificate Program in Project Management
Focused on PMO frameworks, Stake holder engagement, risk management, and strategic delivery aligned with global standards
- Developed skills in project planning, scheduling, and resource allocation for effective project execution
- Gained expertise in stakeholder communication, engagement, and management across diverse teams
- Learned techniques for risk identification, assessment, and mitigation in complex projects
- Implemented project monitoring and control methods to ensure adherence to timelines and budgets
- Acquired knowledge on integrating project management practices within pharmaceutical and healthcare projects, emphasizing regulatory compliance.
- Applied principles of quality management and performance measurement in project delivery
Certification
Project Management Profession (PMP) from PMI@ Feb 2026
Timeline
Sr.QA Analyst
Vantive (Payroll: Rangam Infotech)
05.2025 - Current
Deputy General Manager-Pharmacovigilance Services
Accenture
10.2024 - 03.2025
Safety Aggregate Report Specialist II
IQVIA Pvt Ltd
02.2024 - 10.2024
Senior PV Professional
Teva Pharmaceuticals
07.2021 - 01.2024
Aggregate Report Specialist I
IQVIA Pvt Ltd
09.2018 - 06.2021
Senior PV Specialist
APCER Life Sciences
12.2016 - 08.2018
Safety Process Expert
Accenture Solutions Pvt Ltd
10.2015 - 12.2016
Clinical Data Co-Coordinator
Quintiles Pvt Ltd
12.2014 - 10.2015
Professional Certificate Program In Project Management - Project Management
Indian Institute of Technology
M. Pharmacy - Pharmaceutics
Seven Hills College of Pharmacy
B. Pharmacy - Pharmaceutical Sciences
Annamacharya College of Pharmacy
Intermediate -
Board Of Intermediate
SSC -
Board of Secondary Education