Parexel Medical Writer I II Pharmacovigilance

Parexel Hiring – Medical Writer I / Medical Writer II | Patient Safety

Parexel is hiring Medical Writer I / Medical Writer II – Patient Safety for its Medical Affairs team in India. The role focuses on pharmacovigilance, aggregate safety reports, signal detection and evaluation, literature review, Risk Management Plans and regulatory safety documentation. Candidates with Life Sciences, Health or Biomedical Sciences qualifications and relevant pharmacovigilance or medical writing experience can apply.

Medical Writer I / Medical Writer II – Patient Safety

Job Details

• Company: Parexel
• Position: Medical Writer I / Medical Writer II
• Category: Medical Affairs
• Job ID: R0000046349
• Primary Location: Hyderabad, India
• Additional Locations: Bengaluru, India; Remote, India; Mohali, India
• Work Mode: Hybrid / On-site / Remote, as applicable

About Parexel

Parexel is a global clinical development partner providing clinical and consulting solutions to the life sciences industry. The company works with biopharmaceutical companies and research sites to support clinical trials and the development of new therapies.

Medical Writer I – Patient Safety

Key Responsibilities

• Prepare, compile and lead the development of scheduled and ad-hoc aggregate safety reports, including:

  • Periodic Safety Update Reports (PSURs)
  • Periodic Benefit-Risk Evaluation Reports (PBRERs)
  • Development Safety Update Reports (DSURs)
  • Other regulatory safety documents

• Conduct independent signal detection using safety data from 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 safety trends.
• Support signal evaluation and epidemiology assessments.
• Manage signal tracking activities and maintain comprehensive signal logs.
• Identify and resolve discrepancies in safety data sources.
• Ensure data integrity across safety deliverables.
• Assist with preparing and updating Risk Management Plans (RMPs) and related documents.
• Manage routine client interactions and queries.
• Maintain audit-ready documentation and properly archive source materials.
• Support inspection-readiness activities and regulatory compliance.

Medical Writer II – Patient Safety

In addition to the responsibilities above, the Medical Writer II role includes:

• Mentor junior team members on technical and soft skills.
• Provide constructive feedback.
• Lead complex client discussions.
• Manage multi-stakeholder document review cycles.
• Contribute to process improvement initiatives.

Eligibility & Qualifications

Educational Qualification

Candidates should have a University degree in Life Sciences, Health or Biomedical Sciences, such as:

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

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

Experience

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.

Required Skills

• Strong analytical thinking
• Scientific writing
• Problem-solving
• Pharmacovigilance knowledge
• Understanding of global pharmacovigilance regulations
• Medical terminology and safety-related concepts
• Medical writing tools
• Microsoft Office applications
• Pharmacovigilance databases
• Coding dictionaries such as MedDRA and WHO-DD
• Strong communication and organizational skills
• Excellent time management
• Ability to prioritize multiple concurrent projects
• Attention to detail
• Ability to work with internal teams and external clients

Preferred Qualifications

• Prior 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
• Understanding of regulatory submission processes across multiple regions

Eligible Qualification Courses

B.Pharm | M.Pharm | Pharm.D | B.Sc. Microbiology | M.Sc. Microbiology | B.Sc. Biochemistry | M.Sc. Biochemistry | B.Sc. Biotechnology | M.Sc. Biotechnology | Biophysics | BDS | BPT | Other relevant Life Sciences, Health or Biomedical Sciences qualifications

Location & Work Mode

Primary Location: Hyderabad, India

Additional Locations:

• Bengaluru
• Remote, India
• Mohali

Work Mode: Hybrid / On-site / Remote, depending on the applicable position and location.

How to Apply

Interested and eligible candidates can apply through the official Parexel careers portal.

Apply for Medical Writer I / Medical Writer II – Parexel

Job Summary