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Senior Medical Writer, Patient Safety
ParexelSenior Medical Writer analyzing safety documentation for clinical trials at Parexel. Leading safety submissions and collaborating with cross-functional teams to ensure compliance and quality standards.
About the role
Key responsibilities & impact- Leads the preparation of complex scheduled and unscheduled aggregate safety reports across multiple product types and regulatory regions.
- Develops strategic approaches for challenging safety submissions.
- Reviews and approves high-complexity safety documents.
- Manages meeting logistics including scheduling, agenda drafting, and minute preparation.
- Designs and implements advanced signal detection plans tailored to specific product profiles.
- Leads signal detection for priority products by conducting expert-level analyses.
- Authors and reviews high-priority signal assessment reports and health authority response documents.
- Prepares and handles reviews of health authority response documents.
- Collaborates with cross-functional teams to ensure RMPs are scientifically robust and compliant.
- Demonstrates deep expertise in safety profiles across a wide range of therapeutic areas.
Requirements
What you’ll need- Prior experience in pharmacovigilance, or related fields is preferred.
- Demonstrates Solid understanding of global pharmacovigilance regulations, medical terminology, and safety-related concepts.
- Preferred qualifications include a university degree in Life Sciences, Health, or Biomedical Sciences—such as Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, Dentistry, or Physiotherapy etc or equivalent combination of training and work experience.
- Clinical exposure in hospital-based environments is considered advantageous.
Benefits
Comp & perks- Health insurance
- Flexible work arrangements
- Professional development opportunities
ATS Keywords
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Hard Skills & Tools
signal detectionsafety report preparationsafety document reviewstrategic safety submissionshealth authority response document preparationexpert-level analysisaggregate safety reportssafety-related conceptsmedical terminologypharmacovigilance
Soft Skills
leadershipcollaborationorganizational skillscommunicationagenda draftingminute preparationlogistics managementanalytical skillsproblem-solvingattention to detail