Safety Writer
Fortrea
full-time
Posted on:
Location Type: Hybrid
Location: Mumbai • India
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About the role
- Responsible for the preparation and review of aggregate safety, risk management, and signal detection documents
- Perform report management activities and lead client communication for the assigned reports
- Assist other medical writers in their safety deliverables, act as a co-author for complex or large reports
- Provide oversight and quality review of reports prepared by peers or junior associates
- Conduct scientific literature searches and review for safety reports or routine surveillance activities
- Ensure timely delivery of high-quality documents to internal customers and sponsors/clients
- Foster excellent working relationships with all clients, both internal and external
Requirements
- Minimum of first degree in life sciences (or equivalent)
- At least 3 years' experience in the pharmaceutical industry, or at least 2 years of it in medical writing
- Excellent command of written and spoken English
- Knowledge of MS Office
- Good organizational and time management ability
- Excellent interpersonal skills
- Scientific or Clinical research experience desirable
- Good understanding of regulatory requirements, good Pharmacovigilance practices and ICH GCP guidelines
Benefits
- Health insurance
- Flexible work arrangements
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
medical writingreport managementscientific literature searchesquality reviewsafety deliverablesrisk managementsignal detectionregulatory requirementsPharmacovigilance practicesICH GCP guidelines
Soft skills
organizational abilitytime managementinterpersonal skillscommunication skillsclient relationship management