Job Title
Safety Writer III
Work Schedule
Standard (Monday–Friday)
Work Environment
Office-based
Company Overview
This role is with Thermo Fisher Scientific, a global leader in scientific research services, laboratory technologies, and pharmaceutical support solutions. The company works with pharmaceutical firms, biotech organizations, and clinical research partners across more than 100 countries.
The role also supports pharmacovigilance and clinical safety writing services, contributing to global drug safety and regulatory compliance.
Job Overview
As a Safety Writer III, you will be responsible for preparing, reviewing, and managing pharmacovigilance safety documents for clinical trials and marketed products. This role operates in a highly regulated environment and involves collaboration with global project teams, clients, and vendors.
You will ensure accurate, compliant, and timely delivery of safety writing outputs that support patient safety and regulatory submissions.
Key Responsibilities
Safety Writing & Documentation
Author, review, and quality-check safety reports, including:
DSURs (Development Safety Update Reports)
PSURs/PBRERs (Periodic Safety Update Reports / Benefit-Risk Evaluation Reports)
PA(D)ERs (Periodic Adverse Drug Experience Reports)
RMPs (Risk Management Plans)
Handle documents of varying complexity (low to high)
Support regulatory submission content for clinical and marketed products
Project Management
Manage timelines, deliverables, and multiple safety writing projects
Conduct kick-off meetings and coordinate project activities
Track budgets, forecasts, and project metrics
Communicate with internal teams, clients, and vendors
Regulatory & Compliance
Ensure compliance with global pharmacovigilance regulations
Follow ICH and US safety reporting guidelines
Review regulatory publications to stay updated on requirements
Leadership & Collaboration
Act as primary point of contact for assigned deliverables
Mentor and guide junior team members
Resolve project issues using independent judgment
Participate in audits, inspections, and client meetings
Required Qualifications
Bachelor’s or higher degree in a scientific discipline
Minimum 6 years of experience in pharmacovigilance/safety writing
Required Skills
Technical Expertise
Strong knowledge of ICH guidelines and US aggregate safety reporting
Experience with DSURs, PSURs/PBRERs, PA(D)ERs, and RMPs
Core Competencies
Medical-scientific writing and data interpretation skills
Strong attention to detail
Advanced critical thinking and problem-solving ability
Excellent project management and multitasking skills
Ability to handle complex regulatory documentation
Communication & Leadership
Strong written and verbal English communication skills
Ability to mentor and guide junior professionals
Ability to work effectively in global teams
Tools & Systems
Advanced Microsoft Office skills (Word, Excel, Outlook)
Ability to work across multiple regulatory and client systems
Role Expectations
Lead-level individual contributor role
High responsibility for accuracy and compliance
Exposure to global regulatory environments
Requires independent decision-making and escalation handling
Why Join
You will be part of a global scientific organization focused on improving patient safety and advancing healthcare innovation through strong pharmacovigilance and regulatory science capabilities.
Summary (Simple View)
This is a senior pharmacovigilance safety writing role focused on:
Regulatory safety reports
Clinical trial and marketed product safety documents
Project leadership and mentoring
Global compliance (ICH / US FDA standards)
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Remote, India | Siliguri |Illinois :
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