Principal Medical Writer, Patient Safety

Parexel

Principal Medical Writer handling complex aggregate safety reports worldwide at Parexel. Managing safety signal detection, collaborating with cross-functional teams and providing strategic scientific expertise.

Posted 5/22/2026full-timeRemote • 🇮🇳 IndiaLeadWebsite

About the role

Key responsibilities & impact

Independently lead the preparation/update of complex aggregate safety reports across multiple product types
Manage the distribution of final reports to stakeholders, including partners and health authorities
Leads advanced safety signal detection and management for key products
Collaborates with cross-functional teams to analyze complex safety data
Provides strategic scientific expertise across therapeutic areas

Requirements

What you’ll need

Prior experience in pharmacovigilance or related fields is preferred
Solid understanding of global pharmacovigilance regulations, medical terminology, and safety-related concepts
University degree in Life Sciences, Health, or Biomedical Sciences
Clinical exposure in hospital-based environments is considered advantageous

Benefits

Comp & perks

Health insurance
Retirement plans
Paid time off
Flexible work arrangements
Professional development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

safety signal detectionaggregate safety reportsdata analysispharmacovigilancemedical terminology

Soft Skills

leadershipcollaborationstrategic expertise

Certifications

university degree in Life Sciencesuniversity degree in Healthuniversity degree in Biomedical Sciences