- Canvas painting & drawing
- Playing chess
- Cooking
- Traveling and trekking in the hill’s areas
- Listening to music
Prabhat Kumar Behera
Mohali
Summary
Highly skilled Patient Safety and Pharmacovigilance professional with nearly three years of experience in drug development, clinical safety, and regulatory affairs. Expertise includes managing Individual Case Safety Reports (ICSRs) from diverse sources and supporting the preparation of periodic safety update reports (PSUR), SDEA agreements, case narrative writing, and medical writing, all while adhering to FDA 21 CFR Part 300 and EU MDR vigilance standards. Proven track record in coordinating Corrective and Preventive Actions (CAPAs), managing deviations, and ensuring compliance with global regulatory requirements set by the FDA, EMA, and MHRA. Committed to maintaining the highest standards of patient safety and transparency, with a proactive approach to identifying and resolving safety risks while mentoring junior team members on product-specific safety information.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Patient Safety Associate II
Parexel International (India) Pvt. Ltd.
Mohali, India
07.2025 - 02.2026
- Executed detailed analysis and management of ICSRs derived from clinical trials and post marketing reports, adhering to stringent global regulatory standards.
- Performed detailed quality analysis of 2000+ ICSRs to support enhanced safety monitoring and improve reporting precision.
- Demonstrated expertise in EU MDR vigilance and in-vitro diagnostics MDR, managing device cases and ensuring product compliance.
- Conduct reportable event reconciliation, migrations across clinical and safety databases, identify and resolve non-matching database.
- Executed thorough quality assessments of case narratives and medical write-ups, maintaining high standards for all submissions.
- Monitor and manage regulatory timelines for safety submissions for all clinical cases, literature cases and Business partners cases as per FDA and EMA Health Authorities.
- Supports periodic safety update reports (PSUR) preparation, SDEA agreements.
- Contribute to CAPA and root cause analysis
- Experienced Good mentoring skills to train Juniors colleagues on product safety information (Oncology, cardiology, vaccines etc. and Device case management and handlings.
- Monitored patient safety incidents, ensuring timely reporting and compliance with regulatory standards.
- Ensured adherence to regulatory timelines by submitting expedited SAE reports promptly.
Patient Safety Associate I
Parexel International (India) Pvt. Ltd.
Mohali, India
05.2023 - 06.2025
- Processed and reviewed ICSRs from clinical and post-marketing sources with global regulatory requirements.
- Conducted comprehensive safety evaluations including clinical assessments for adverse events, seriousness criteria, and causality assessments, expectedness tools assessments based on RSI including Investigator’s Brochure (IB), Core Data Sheet (CDS), and local packagings.
- Collaborated with cross functional teams including medical reviewers, regulatory affairs, and clinical teams to ensure safety compliance and case resolution.
- Supported convention-related training delivery and query resolution on ICSR intake, triage and data entry and compliant handling as well.
- Conducted spot check analysis and participated in quality review activities.
- Conduct database reconciliations with Data Management teams
- Review and assesses the validity of literature abstracts and articles, with follow-up processing as required for safety data entry.
- Ensures that the individual training records are kept current in alignment with inspection readiness requirements.
- Collaborated with cross-functional teams to develop and implement patient safety protocols.
- Conducted thorough processing of 15,000+ ICSR entries, contributing to enhanced safety monitoring and reporting accuracy.
Intern
ROCHE PHARMACEUTICAL PVT. LTD.
New Delhi, India
01.2021 - 06.2021
- Gained expertise in understanding and applying clinical trial rules and regulatory submission protocols to ensure compliance in India and globally, including USA and European Union.
- Handling dossier submission.
- Prepared project presentations and reports to assist senior staff.
Intern
City Hospital
Berhampur, India
01.2021 - 02.2021
- Assisted in enhancing patient care through clinical pharmacy practices in outpatient and critical care environments. Supported management of 30 patients in outpatient department and over 500 in dispensing department. Conducted thorough reviews of prescriptions to achieve precise medication dispensing.
Education
Master of Pharmacy (M. Pharma) - Pharmaceutical Regulatory Affairs
Chitkara University
Punjab07.2023
Bachelor of Pharmacy (B. Pharmacy) - Pharmaceutical Sciences
Roland Institute of Pharmaceutical Sciences (RIPS)
Berhampur06.2021
11th 12th - PCMB
Khallikote Juniors College
Berhampur, Odisha01.2015
Matriculation -
Saraswati Vidya Mandir
Berhampur, Odisha01.2013
Skills
- Clinical Safety Assessment
- Understanding of Good Clinical Practice (GCP) in clinical safety documentation & Good Pharmacovigilance Practice
- Causality & Expectedness Evaluation
- Case Processing & Case triage
- Expedited and Non-expedited Safety Report Submission
- KPI development
- Effective communication skills
- Case Narrative writing
- ARGUS/ArisG (LSMV) Safety Database Management
- IVP Database Handling (IQVIA)
- MedDRA Medical Events Coding
- Proficient in Microsoft Office Suite
- Mentoring skills
- Independent work proficiency
- Compliance writing proficiency
- Quality improvement
- Multitasking Abilities
- Teamwork
- Problem-solving
- Time management abilities
Certification
- Certified Course on Pharmacovigilance, Clinical Research & Clinical Data management and Medical Writing, Clini-India, Bangalore
- Regulatory Compliance Training - FDA and EMA Guidelines
- MedDRA Coding Proficiency
Interests
Publications
- Behera, P.K., 2022, "Therapeutic potential of gallic acid in Obesity: Considerable Shift!", Obesity Medicine, 37, 100473
- Behera, P.K., 2023, "Unravelling the role of chitosan for nasal drug delivery systems: A review.", Carbohydrate Polymer Technologies and Applications, 5, 100316
- Behera, P.K., 2024, "Free Radicals and Kidney Disorders", Book Chapter, 25, Apple Academic Press
Timeline
Patient Safety Associate II
Parexel International (India) Pvt. Ltd.
07.2025 - 02.2026
Patient Safety Associate I
Parexel International (India) Pvt. Ltd.
05.2023 - 06.2025
Intern
ROCHE PHARMACEUTICAL PVT. LTD.
01.2021 - 06.2021
Intern
City Hospital
01.2021 - 02.2021
Master of Pharmacy (M. Pharma) - Pharmaceutical Regulatory Affairs
Chitkara University
Bachelor of Pharmacy (B. Pharmacy) - Pharmaceutical Sciences
Roland Institute of Pharmaceutical Sciences (RIPS)
11th 12th - PCMB
Khallikote Juniors College
Matriculation -
Saraswati Vidya Mandir