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Medical Writer I, Patient Safety-Job-7

Parexel
Parexel
1-3 years
Not Disclosed
Bangalore, India
10 Feb. 16, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Medical Writer I – Patient Safety

Location: Bengaluru, India
Job Category: Medical Sciences / Pharmacovigilance
Experience Required: 1–3 years in medical writing, pharmacovigilance, or related life sciences roles


About Parexel

Parexel is a global leader in biopharmaceutical services, providing innovative solutions across clinical research, regulatory affairs, and patient safety. Our teams support the development and commercialization of life-saving therapies worldwide. At Parexel, you will work in a collaborative, inclusive environment that values scientific excellence, integrity, and continuous learning.


Role Overview

We are seeking a Medical Writer I – Patient Safety to contribute to pharmacovigilance documentation and safety analysis. The role involves preparing high-quality safety reports, supporting signal detection, and assisting in risk management activities for assigned products. This position requires strong scientific writing skills, attention to detail, and knowledge of pharmacovigilance regulations.


Key Responsibilities

Safety Medical Writing & Reporting

  • Prepare and compile aggregate safety reports such as PSURs, PBRERs, DSURs, PADERs, SASRs, ARBE reports, and safety statements following global templates and regulatory guidance.

  • Independently lead simpler safety reports and support medium-complexity reports under guidance.

  • Incorporate team and client feedback, ensuring data integrity, consistency, and quality.

  • Coordinate submission of safety documents to regulatory authorities across multiple regions.

  • Generate supporting documentation, including labeling comparisons, appendices, and INN checks.

Safety Analysis & Signal Management

  • Conduct quantitative and qualitative safety data analysis to identify potential safety signals.

  • Maintain signal tracking logs and assist in preparing signal assessment documents such as DSRs and SERs.

  • Perform literature reviews to summarize safety findings for ongoing evaluations.

  • Ensure data consistency and resolve discrepancies in line listings and databases.

Risk Management & Scientific Support

  • Assist in developing and updating Risk Management Plans (RMPs) and associated documentation.

  • Maintain knowledge of product safety profiles and therapeutic areas.

  • Demonstrate proficiency with pharmacovigilance coding dictionaries (MedDRA, WHO-DD).

  • Contribute to team discussions, provide scientific input, and communicate progress effectively.

Client Engagement & Quality Compliance

  • Manage routine client interactions and escalate complex issues appropriately.

  • Maintain high-quality deliverables, adhere to global regulatory standards, and support audit readiness.

  • Participate in continuous improvement initiatives and maintain proper documentation for inspections.

Learning, Innovation & Technology

  • Apply new tools and technologies to enhance reporting efficiency and quality.

  • Continuously update skills through advanced training and contribute to team productivity.


Required Skills & Competencies

  • Strong analytical and problem-solving skills for interpreting complex safety data.

  • Excellent scientific writing, documentation, and communication skills.

  • Knowledge of pharmacovigilance regulations, safety reporting requirements, and coding dictionaries (MedDRA, WHO-DD).

  • Strong organizational skills with the ability to manage multiple projects and meet deadlines.

  • Collaborative mindset with experience working in cross-functional, global teams.

  • Proficiency in Microsoft Office and familiarity with pharmacovigilance databases is preferred.


Education & Experience

  • Education: Degree in Life Sciences, Health, or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, Dentistry, Physiotherapy, or related fields).

  • Experience: 1–3 years in medical writing, pharmacovigilance, drug safety, or related life sciences roles. Clinical or hospital-based exposure is a plus.


Why Join Parexel

  • Work with a globally recognized leader in clinical research and patient safety.

  • Collaborate on cutting-edge projects across therapeutic areas with international teams.

  • Access learning opportunities, career growth pathways, and a supportive work culture.

  • Contribute to global healthcare impact through high-quality medical writing and pharmacovigilance.