Senior Safety Writer
Fortrea
full-time
Posted on:
Location Type: Remote
Location: India
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Job Level
Tech Stack
About the role
- Lead the preparation and review of aggregate safety, risk management, signal detection, and benefit-risk evaluation reports
- Responsible for end-to-end report management, including planning, authoring, and managing review, approval, and submission steps
- Apply safety domain knowledge and process expertise to manage deliverables of medium to high complexity
- Ensure timely delivery of high-quality documents to internal customers and sponsors/clients
- Coach, mentor, and provide shadowing opportunities and hands-on experience for the training and development of medical writers and junior associates
- Support project management activities
- Foster excellent working relationships with all clients, both internal and external.
Requirements
- Minimum of first degree in life sciences (or equivalent)
- At least 4 years’ experience in the pharmaceutical industry, or at least 3 years of it in medical writing
- Excellent command of written and spoken English
- Good written and verbal communication skills
- 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
- Available for travel 10% of the time including overnight stays as necessary consistent with project needs and office location.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
medical writingrisk managementsignal detectionbenefit-risk evaluationreport managementregulatory requirementsPharmacovigilance practicesICH GCP guidelinesscientific researchclinical research
Soft Skills
coachingmentoringcommunicationorganizational skillstime managementinterpersonal skillsrelationship buildingteam collaborationproblem-solvingleadership