Parexel is hiring for Medical Writer I / Medical Writer II – Patient Safety across multiple locations in India. The roles focus on pharmacovigilance, regulatory safety documentation, signal detection, safety data analysis, and preparation of aggregate safety reports.
Candidates with a degree in Pharmacy, Life Sciences, Health Sciences, or Biomedical Sciences and relevant experience in pharmacovigilance or medical writing can apply for these positions.
Job Details
| Particulars | Details |
|---|---|
| Company | Parexel |
| Job Title | Medical Writer I / Medical Writer II |
| Department | Patient Safety |
| Job Requisition ID | R0000046349 |
| Job Location | Hyderabad, Bengaluru, Mohali |
| Work Mode | Hybrid, On-site, or Remote |
| Experience | 2+ years for Medical Writer I; 4+ years for Medical Writer II |
| Qualification | University degree in Life Sciences, Health, or Biomedical Sciences, or equivalent training and work experience |
| Job Posting | Posted today |
Positions Available
1. Medical Writer I – Patient Safety
Candidates should have at least 2 years of experience in pharmacovigilance, medical writing, or a related field. The role involves preparing regulatory safety documents, conducting signal detection activities, reviewing safety literature, and supporting risk management documentation.
2. Medical Writer II – Patient Safety
Candidates should have at least 4 years of experience in pharmacovigilance, medical writing, or a related field. In addition to technical responsibilities, this position involves mentoring junior team members, leading complex client discussions, managing document review cycles, and contributing to process improvement initiatives.
Job Locations
Parexel lists the following locations for these opportunities:
- Hyderabad, Telangana
- Bengaluru, Karnataka
- Mohali, Punjab
- Mohali – Remote
- Hyderabad – Remote
Additional locations are available under the job listing.
Key Responsibilities
Selected candidates will be responsible for the following activities:
- Prepare and develop aggregate safety reports, including Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), and Development Safety Update Reports (DSURs).
- Conduct independent signal detection using safety databases, clinical data, scientific literature, and regulatory websites.
- Prepare Drug Safety Reports (DSRs) and Signal Evaluation Reports (SERs).
- Conduct systematic literature searches and reviews to identify safety trends and support signal evaluation.
- Maintain signal tracking logs and resolve discrepancies in safety data sources.
- Assist in preparing and updating Risk Management Plans (RMPs).
- Communicate with clients, respond to routine queries, provide status updates, and escalate complex issues when required.
- Maintain audit-ready documentation, archive source materials, and support regulatory inspection readiness.
Additional responsibilities for Medical Writer II:
- Mentor junior team members and provide constructive feedback.
- Lead complex client discussions.
- Manage document review cycles involving multiple stakeholders.
- Contribute to process improvement initiatives.
Eligibility and Qualifications
Candidates applying for the Parexel Medical Writer I / Medical Writer II jobs should meet the following requirements:
- A university degree in Life Sciences, Health Sciences, or Biomedical Sciences, including Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, Dentistry, or Physiotherapy.
- Alternatively, an equivalent combination of training and work experience.
- At least 2 years of relevant experience for Medical Writer I.
- At least 4 years of relevant experience for Medical Writer II.
- A solid understanding of global pharmacovigilance regulations, medical terminology, and safety-related concepts.
- Experience in pharmacovigilance, medical writing, or a related field.
Required Skills
The job description highlights the following skills and competencies:
- Scientific writing and analytical thinking.
- Safety data interpretation and problem-solving.
- Knowledge of global pharmacovigilance regulations.
- Familiarity with medical writing tools and Microsoft Office applications.
- Familiarity with pharmacovigilance databases and coding dictionaries, including MedDRA and WHO-DD.
- Strong communication and organizational skills.
- Time management and the ability to prioritize multiple projects.
- Attention to detail and commitment to regulatory compliance.
- Ability to collaborate with internal teams and external clients.
Preferred Qualifications
Parexel also identifies the following as preferred qualifications:
- Previous experience in pharmacovigilance or safety assessment.
- Clinical exposure in hospital-based environments or direct clinical research experience.
- Expertise in specific therapeutic areas or product types.
- Familiarity with pharmacovigilance systems and regulatory submission processes across multiple regions.
