Rajkumar Reddy Muppidi, PharmD., RPh, M.Sc.
Sydney
Summary
Experienced Pharmacovigilance and Safety Patient Officer working in CRO and Pharmaceutical industries. Demonstrated expertise in case processing, signal detection, PSUR/PBRER, literature monitoring, and client reconciliation. Proficient in GVP, MHRA and EMA guidelines. Highly motivated with transferable skills and instilled with a strong work ethic and unrelenting ambition for skill set development. Proven ability to thrive in challenging environments, constantly seeking opportunities for personal growth in the pharmacovigilance industry.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Pharmacovigilance and Patient Safety Officer
Ethypharm UK
04.2022 - Current
- Responsible for end-to-end case processing (from receipt to submission) including MLM, L2A and MHRA downloads, handling PV mailbox and perform Quality Control of cases
- Leveraged monthly case review, quarterly prioritization to identify new signals and thorough signal evaluation based on available data and scientific literature review and analysis
- Played a key role in the preparation of line listings and summary tabulations in PBRER format from database for signal management, PSUR and EURD list
- Drafting PBRER (PSUR) and Signal Detection reports according to internal SOPs including the calculation of report ratio (RRR) and PRR based on the number of cases in the DLP and updating signal tracker
- Responsible for formatting of Reference safety information (RSI), coordinated PSMF annex updates and xEVMPD activities
- Preparing monthly QPPV report to present KPIs to UK/EU QPPV
- Collecting quality inputs, regulatory inputs, partner inputs and safety information related to the product from relevant department and sources (e.g., PRAC, CMDh, literature and regulatory intelligence)
- Performed SDEA reconciliation with partners/ stakeholders and internal reconciliations (Medical Information and Quality Complaint Team) and responding to Medical Information (MI) enquiries via calls and emails
- Mentored new Pharmacovigilance staff and provided PV training (internal and external)
- Assisted in the preparation, review and update of the pharmacovigilance SOPs and Work Instructions (WI) in continuous improvement
- Managed xEVMPD activities, checking for EMC uploads and ensuring compliance with regulatory requirements
- Supporting direct manager with Quality Assurance, Regulatory Affairs and Medical Information Activities
- Actively participated in PV audits and inspections and handling of planned and unplanned deviations and CAPAs
- Extracting Literature articles from Orbit database and accessing them for valid ICSR’s and PSUR related safety information
- Narrative Writing: assumed responsible for writing medically relevant safety narrative of cases and review incoming SAE data for completeness and accuracy
Pharmacovigilance Associate
Arcolab Pvt. Ltd
04.2024 - 03.2025
- Contributed significantly to the preparation of line listings and summary tabulations in PBRER format using safety databases for signal management and PSUR
- Drafted PBRER (PSUR) and PADER reports in compliance with internal SOPs, ensured timely updates to tracking systems
- Responsible for coordinating PSMF annex updates and managing xEVMPD-related activities
- Prepared monthly QPPV reports, presenting key performance indicators (KPIs) to the UK/EU QPPV for regulatory oversight
- Collected and evaluated quality, regulatory, partner, and safety inputs from cross-functional teams and external sources (e.g., PRAC, CMDh, literature, regulatory intelligence)
- Oversaw regulatory filter updates and ensured xEVMPD database compliance in line with EMA standards
- Managed submission of individual case safety reports to the MHRA and EMA, ensuring regulatory compliance and timely delivery
Assistance Pharmacist
Pearl Chemist
London
04.2021 - 04.2022
- Reviewed packages and medication bottles for proper labeling before distributing to patients.
- Answered patient questions and data requests.
- Delivered pharmacological education to patients by responding to and answering questions and explaining medication side effects.
- Counseled patients on drug therapies to ensure proper intakes.
- Participated in continuing education to stay current with new medications, technology, and pharmacy practices.
- Monitored medication inventory levels and kept detailed documentation in company software.
- Checked medications for content, accuracy and completeness of drug packaging and labeling.
- Trained individuals in how to use devices to promote optimal medical support.
- Collaborated with healthcare providers to develop and implement patient-specific medication plans.
Drug Safety Associate
Bioclinica, LTD
10.2019 - 12.2020
- Responsible for case processing of individual case safety reports into the safety database based on timelines including literature, legal, clinical trial cases and handling PV mailbox
- Proficient in reviewing serious adverse events, spontaneously reported adverse reactions, and clinical trial cases
- Responsible for collecting raw literature reports from Ovid database
- MedDRA coding dictionary (WHO-DD) and writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields for initial and follow up reports
- Reviewing Suspected Unexpected Serious Adverse Reaction (SUSAR) cases in clinical studies, strictly compliant to 7 day and 15-day timeline
- Provide the feedback to data entry team members for the errors/findings noted and assist in overall quality improvement of the process
Education
MSc - Pharmaceutical Sciences
University of Greenwich
London, UK01.2022
Doctor of Pharmacy -
Rajiv Gandhi University of Health And Sciences
Bangalore09.2019
Websites
Certification
- Proficient in using databases like Argus, ArisG, Global Safety easy and medical dictionaries.
- Undergone training for managing team, had experience in interacting with clients.
- MedDRA and xEVMPD trainings and various training sessions conducted by pharmacovigilance groups, Regulatory Intelligence, SAP sales and Change control.
- Attended multiple PIPA trainings and webinars.
Timeline
Pharmacovigilance Associate
Arcolab Pvt. Ltd
04.2024 - 03.2025
Pharmacovigilance and Patient Safety Officer
Ethypharm UK
04.2022 - Current
Assistance Pharmacist
Pearl Chemist
04.2021 - 04.2022
Drug Safety Associate
Bioclinica, LTD
10.2019 - 12.2020
MSc - Pharmaceutical Sciences
University of Greenwich
Doctor of Pharmacy -
Rajiv Gandhi University of Health And Sciences
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