Ch. Bhargava Krishna
Aspiring Professional Regulatory Medical Writer | Quality Reviewer skilled in CER, PSUR, PMSP, PMCF, SSCP, CEP, CSR, PBRER, HCSR & PPA — delivering precision, compliance, and innovation in every report.
- Role
- Medical Writer at HCLTech
- Location
- Vijayawada, AP, IN
- LinkedIn followers
- 500 followers
About Ch. Bhargava Krishna
I’m a Medical Affairs Specialist with a solid foundation in Regulatory and Clinical writing, specializing in medical devices and diagnostics. Specialized in Regulatory reports like: Clinical Evaluation Reports (CER)| Periodic Safety Update Reports (PSUR) 🩺 Post-Market Surveillance (PMS)|🧩Post-Market Clinical Follow-up (PMCF)|Health Canada Safety Report (HCSR) Summary of Safety & Clinical Performance (SSCP)| 🧾Product Performance Analysis (PPA) With a proven track record of 15+ successful regulatory and clinical documentation initiatives across global markets, I combine precision, compliance, and strategic communication to deliver high-quality results.I’m also skilled in conducting audits and quality reviews for both internal and client documentation, ensuring alignment with EU MDR and international regulatory standards.Driven by precision, quality, and continuous learning, I’m passionate about bridging science, regulation, and patient safety through impactful medical writing.I ensure full compliance with EU MDR, IVDR, and FDA regulations, crafting documents that strengthen regulatory submissions and uphold product quality and patient safety.Driven by attention to detail and innovation, I thrive in dynamic, cross-functional environments, leveraging my strengths in medical writing, project management, and regulatory strategy to bridge science, compliance, and patient impact.Let’s connect and explore opportunities to advance healthcare communications and regulatory excellence together. Reach me at: b••••••••@gmail.com
Experience
Medical Writer
Jan 2021 — Present · Vijayawada, IN
Currently working as Medical writer At HCL Technolgies
Education
Chalapathi Institute of Pharmaceutical Sciences, Lam
Master of pharmacy, Pharmacology
2017 — 2019
Narsaraopeta institute of pharmaceutical sciences
Bachelor of Pharmacy - BPharm, Pharmacy
2013 — 2017
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