Harish Kumar Pharmacology
Principal Medical Writer (Safety Scientist), SME & PV Expert | 10+ Years PV Experience | Risk Management Plans, Effectiveness check for aRMMs, PBRER, PSUR, DSUR, PADER | Oncology l Originators, Biosimilars | PV Trainer
- Role
- Principal Medical Writer, Patients Safety at Parexel
- Location
- Chandigarh, CH, IN
- LinkedIn followers
- 500 followers
About Harish Kumar Pharmacology
Pharmacovigilance and medical writing professional with approximately 10 years of experience in the preparation, quality review, & lifecycle management of key safety regulatory documents, including PBRER/PSUR, DSUR, RMP, PADER, and aCOs for biosimilar/originator, & generic products. Demonstrated expertise in the preparation of global & country-specific RMPs, including low and High complex submissions and related documents such as Additional Risk Minimization Measures (aRMMs), Pharmacovigilance Measures (aPVMs), DHPC and Targeted Follow-up Questionnaires (TFuQs). Proficient in monitoring Safety Risk Management (SRM) Mailbox & safety profiles and expert statements for PBRERs. Skilled in addressing Health Authority and PRAC queries, preparing formal responses, and integrating feedback into regulatory documents. Strong background in case processing, including triage, data entry, validation, and quality review of ICSRs across multiple sources. Certified Train-the-Trainer with experience leading refresher sessions, onboarding programs, and training academies. Experienced mentor for PV scientists and medical writers, supporting both case processing and authoring activities. Supported in company and client audits.Awards: 02: The Great Indian Award (2016), Pride of country Award (2017)Publications: 25, Journals: 08, Conferences: 10, Book Chapters: 02, Medical Magazines & News: 05Scholarships: 02: Masters (AICTE), PhD (Sir C. V. Raman)Entrances Qualified: 02: GATE 2009, PhD (UGC) 2012: 1st RankMedical Writing Certificate Program (Intermediate Level), Parexel Medical Writing Training Academy, 2024.Certificate of appreciation, Team Award, BRAVO GSS Program, Q2 2024, PAREXEL.Certificate of appreciation, Country Head Recognition Program, Q1 2024, PAREXEL.Certificate for outstanding performance, Country Head Recognition Program, 2022, PAREXEL.Certificate for first position, Parexel India Annual Awards, 2022, PAREXELCertificate of Recognition, Team of the Quarter, Q2 2022, PAREXEL
Experience
Principal Medical Writer, Patients Safety
Dec 2025 — Present
Education
Guru Jambheshwar University
PhD Pharmacology
2012 — 2015
Catalyst Clinical Services Private Ltd.
Professional Diploma in Clinical Research
2007 — 2007
Guru Jambeshwar University
M.Pharmacy
2009 — 2011
Guru Jambheshwar University
B.Pharmacy
2004 — 2008
PharmaSchool, United Kingdom (UK)
Open access Good Clinical Practical Test
2011 — 2012
United States Food and Drug Administration (US FDA)
Scientific investigations
2011 — 2012
BioPharma institute for Pharmacy professionals, Paramus, New Jersey.
GMP Training-documentation and Record keeping, Circulating Tumor cells as Biomarkers,
2011 — 2012
National Institute of Health, USA
Clinical Research Training, Protecting Human Research Participants
2011 — 2012
Stanford University School of Medicine
Case Studies In Medical Errors
2020 — 2020
Catalyst Clinical Services Private Ltd.
Scientific Writing and Creation of Essential Documents
2011 — 2011
Catalyst Clinical Services Pvt. Ltd., New Delhi
Onclogy Clinical Trial Training
2007 — 2012
Stanford University School of Medicine
Associate of Science - AS
2020 — 2020
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