Summary
Overview
Work History
Education
Skills
Certification
Timeline
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Dr.Sneha Aishwarya Subramanian

Dr.Sneha Aishwarya Subramanian

Manchester

Summary

A dedicated clinical pharmacologist with 7 years of comprehensive experience in clinical healthcare and pharmacovigilance, with a specialization in medical review and post-marketing adverse drug reaction (ADR) reporting. Possess in-depth expertise in drug development, including pharmacokinetic and pharmacodynamic profiling, therapeutic applications, and causality assessments. Have successfully managed ICSR cases across multiple regulatory authorities, including MHRA, Canada, EMEA, and Australia. Eligible to work in UK and donot require visa sponsorship.

Overview

7
7
years of professional experience
1
1
Certification

Work History

Drug Safety Physician

Apcer Life Sciences
New Delhi
11.2022 - 11.2023
  • Expertly reviewed ICSRs in APCER's pharmacovigilance database, applying clinical knowledge to provide causality assessment of the cases and offering expert opinions. Conducted spontaneous follow-ups when needed and worked with UK and European clients, gaining insight into EU regulatory and submission guidelines.
  • Proficient in handling Aris g and ARGUS database.

Regulatory Affairs Consultant

Aeon Formlations PVT.LTD.
Chennai
09.2020 - 10.2022
  • Experienced in preparing regulatory submissions (IND, NDA, MAA) and technical documents, with strong knowledge of FDA, EMA, ISO, and cGMP standards. Proficient in technical writing, risk management, and collaborating with cross-functional teams to ensure compliance. Assisted in developing regulatory strategies for product approvals.

Clinical Pharmacology Register

Sri Ramachandra Medical College
Chennai
04.2017 - 08.2020
  • Worked as a resident for 3 years during my MD Pharmacology program at Sri Ramachandra University (CDSCO Zonal Center for PV). Gained expertise in protocol writing, SAE and ADR reporting, causality assessment (PvPI, MEDRA), pharmacokinetics, pharmacodynamics, bioavailability studies, and animal handling. Proficient in GCP/GLP guidelines, drug literature evaluation, and Vigiflow database entry and causality assesment.

Observership

Azidus Laboratories
Chennai
04.2018 - 04.2018
  • Attended observership at Azidus laboratories,a global CRO conducting BA/BE studies and gained a practical knowledge of the operations,conductance and analysis of various BA/BE studies.

Education

Advanced Certification in Medical Writing -

HENDRY HARVIN
10-2024

M.D. - Pharmacology

Sri Ramachandra Medical College
Chennai
08-2020

MBBS -

Tamilnadu Dr.MGR Medical University
Chennai
05-2016

Skills

  • Causality Assement
  • Aris G,Argus Database handling
  • Medical Writing
  • Regulatory Affairs
  • Signal Detection
  • Applied Pharmacology
  • Clinical diagnosis and treatment
  • MS EXCEL
  • MS Word
  • Risk management strategies
  • Cross-Functional Teamwork

Certification

  • ICH GCP CERTIFICATION
  • MEDRA Maintenance and Support Service Organisation(MSSO)
  • Microsoft word Linkedin learning
  • Microsof Excel Linkedin learning

Timeline

Drug Safety Physician

Apcer Life Sciences
11.2022 - 11.2023

Regulatory Affairs Consultant

Aeon Formlations PVT.LTD.
09.2020 - 10.2022

Observership

Azidus Laboratories
04.2018 - 04.2018

Clinical Pharmacology Register

Sri Ramachandra Medical College
04.2017 - 08.2020

Advanced Certification in Medical Writing -

HENDRY HARVIN

M.D. - Pharmacology

Sri Ramachandra Medical College

MBBS -

Tamilnadu Dr.MGR Medical University

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Dr.Sneha Aishwarya Subramanian