Neuropharmacology
ABHISHEK CHANDER
MEDICAL WRITER
Bengaluru,Karnataka
Summary
Medical Writer / Associate Medical Writer specializing in pharmacovigilance, signal detection, and regulatory-compliant medical documentation. Authors SERs, supports PBRER training, and reviews literature and monitored events to strengthen safety evaluation and benefit-risk assessment. Partners with safety physicians and regulatory teams to deliver clear, compliant documentation across global requirements.
Overview
2
2
Languages
6
6
years of professional experience
Work History
Quality Assurance Associate / Trainee
Stanford Pharmaceuticals
09.2020 - 02.2021
- Gained 6 months of experience in pharmaceutical Quality Assurance activities.
- Supported review and documentation of quality-related records and compliance activities.
- Assisted with quality documentation, SOP-related activities, and adherence to established pharmaceutical quality requirements.
- Developed practical understanding of Good Documentation Practices (GDP) and quality systems within a pharmaceutical environment.
- Pharmaceutical Industry Experience
Medical Writer / Associate Medical Writer
Parexel International
01.2024 - Current
- Perform qualitative and quantitative analysis of pharmacovigilance database outputs for signal detection and management.
- Conduct signal validation, prioritization, evaluation, documentation, and ongoing monitoring in alignment with global regulatory requirements.
- Author Safety Evaluation Reports (SERs) supporting benefit-risk assessment activities.
- Trained in PBRER writing, including understanding of report structure, content requirements, and safety data presentation.
- Perform literature surveillance, triage, and analysis for potential safety signals and aggregate safety reporting.
- Conduct monitored event medical assessments, including RSI listedness review, causality assessment, and identification of confounders and risk factors.
- Support safety documentation and reporting in accordance with ICH, FDA, CIOMS, and EU pharmacovigilance requirements.
- Collaborate cross-functionally with safety physicians and regulatory teams to ensure high-quality, compliant medical documentation.
Education
Advanced Diploma - Clinical Research and Pharmacovigilance
M.Pharm - Pharmacology
Maharishi Markandeshwar University
Mullana, Ambala09.2023
B.Pharm - undefined
Shoolini University
Solan08.2021
Skills
Medical and scientific writing
Safety evaluation reports (SERs)
Pbrer writing
Reference safety information (RSI) review
Scientific literature research
Disproportionality analysis
Signal detection and signal management
Literature surveillance, triage and analysis
Benefit-risk assessment
Aggregate safety data review
Accomplishments
- Qualified NIPER JEE.
- Qualified GPAT 2021.
- GPAT 2021 Rank: 251.
Affiliations
- Registered Pharmacist – Himachal Pradesh State Pharmacy Council (HPSPC)
- Registration No.: 46150
PUBLICATIONS
- Chander A, Sharma J, Mahajan S, Dhankhar S, Chauhan S, Saini M, Mehta S. Serotonergic Dynamics in Autism Spectrum Disorder: Unraveling the Intricate Connection. CNS & Neurological Disorders - Drug Targets. 2025;24(7):511–520.
- Dhawan A, Choudhary S, Gupta S, Chander A, Dhanawat M. Avelutiy: A New Era in Medicine — Unraveling the Multifaceted Benefits of Dextromethorphan/Bupropion Combination. Current Drug Therapy. 2024;19(6).
Interests
Diabetes and its microvascular complications
Neurodegenerative diseases
Autism spectrum disorder and gut microbiome axis
Timeline
Medical Writer / Associate Medical Writer
Parexel International
01.2024 - Current
Quality Assurance Associate / Trainee
Stanford Pharmaceuticals
09.2020 - 02.2021
B.Pharm - undefined
Shoolini University
M.Pharm - Pharmacology
Maharishi Markandeshwar University