Parexel is hiring Medical Writer I / Medical Writer II – Patient Safety for its teams in Hyderabad, Bengaluru, and Mohali, including remote opportunities in Hyderabad and Mohali. The role focuses on pharmacovigilance, medical writing, safety signal assessment, regulatory safety documents, and compliance activities.

Job Details

Positions

Medical Writer I

The Medical Writer I role requires 2+ years of experience in pharmacovigilance, medical writing, or a related field. Responsibilities include preparing regulatory safety documents, conducting signal detection and literature reviews, and supporting safety assessment activities.

Medical Writer II

The Medical Writer II role requires 4+ years of experience in pharmacovigilance, medical writing, or a related field. In addition to technical responsibilities, the role includes mentoring junior team members, leading complex client discussions, managing multi-stakeholder document review cycles, and contributing to process improvement.

Responsibilities

• Prepare and lead scheduled and ad-hoc aggregate safety reports, including PSURs, PBRERs, and DSURs.
• Conduct independent safety signal detection using data from safety databases, clinical data, literature, and regulatory websites.
• Apply quantitative and qualitative methodologies to identify potential safety signals.
• Prepare Drug Safety Reports (DSRs) and Signal Evaluation Reports (SERs).
• Conduct systematic literature searches and reviews to summarize safety data and identify emerging trends.
• Manage signal tracking activities and maintain comprehensive signal logs.
• Identify and resolve discrepancies in safety data sources and maintain data integrity.
• Assist with preparation and updates of Risk Management Plans (RMPs) and related documents.
• Manage client queries, provide status updates, and escalate complex issues when appropriate.
• Maintain audit-ready documentation and support inspection readiness activities.
• For Medical Writer II, mentor junior employees, provide feedback, lead complex client discussions, manage review cycles, and support process improvement.

Eligibility / Qualifications

Candidates should have a university degree in Life Sciences, Health, or Biomedical Sciences, including disciplines such as:

• Pharmacy
• Microbiology
• Biochemistry
• Biotechnology
• Biophysics
• Dentistry
• Physiotherapy

An equivalent combination of training and work experience may also be considered.

Experience Required

• Medical Writer I: 2+ years of experience in pharmacovigilance, medical writing, or a related field.
• Medical Writer II: 4+ years of experience in pharmacovigilance, medical writing, or a related field.

Candidates should also have a solid understanding of global pharmacovigilance regulations, medical terminology, and safety-related concepts.

Required Skills

• Analytical thinking
• Scientific writing
• Problem-solving
• Pharmacovigilance knowledge
• Understanding of global pharmacovigilance regulations
• Medical terminology
• Safety assessment concepts
• Medical writing tools
• MS Office applications
• Familiarity with pharmacovigilance databases
• Familiarity with MedDRA and WHO-DD
• Strong communication skills
• Organization and time management
• Ability to prioritize multiple projects
• Attention to detail
• Ability to collaborate with internal teams and external clients

Preferred Qualifications

• Previous experience in pharmacovigilance or safety assessment
• Clinical exposure in hospital-based environments
• Direct clinical research experience
• Expertise in specific therapeutic areas or product types
• Familiarity with pharmacovigilance systems
• Knowledge of regulatory submission processes across multiple regions

Job Location and Work Arrangement

The positions are available across:

• India – Hyderabad
• India – Bengaluru
• India – Mohali
• India – Mohali – Remote
• India – Hyderabad – Remote

The role may be performed in a hybrid, on-site, or remote capacity.

Application Details

Application Link