Medical Writer – Patient Safety

Parexel

Medical Writer-II at Parexel oversees the preparation and review of safety documentation. Ensuring compliance with regulatory requirements and contributing to safety analysis and client engagement.

Posted 5/22/2026full-timeRemote • 🇮🇳 IndiaMid-LevelSeniorWebsite

About the role

Key responsibilities & impact

Leads or contributes to the preparation and compilation of aggregate safety reports.
Reviews and finalizes safety documents for accuracy and compliance.
Coordinates submissions to regulatory authorities.
Conducts literature searches and systematic reviews.
Identifies complex data discrepancies.
Supports development of Risk Management Plans.
Actively contributes to safety strategy discussions.
Serves as primary client liaison for projects.
Monitors KPIs and SLAs for assigned deliverables.
Mentors junior team members by providing training.

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.
Knowledge of safety writing topics and familiarity in pharmacovigilance databases (e.g., MedDRA, WHO-DD).
Education: Preferred qualifications include a university degree in Life Sciences, Health, or Biomedical Sciences—such as Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, Dentistry, or Physiotherapy.
Clinical exposure in hospital-based environments is considered advantageous.

Benefits

Comp & perks

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Hard Skills & Tools

pharmacovigilancesafety writingdata discrepancy identificationrisk management planningliterature searchessystematic reviewsKPI monitoringSLA monitoring

Soft Skills

client liaisonmentoringtrainingcommunicationcollaboration