Safety Writer
Company: Fortrea
Location: Bangalore / Mumbai, India
Employment Type: Full-Time
Department: Pharmacovigilance & Medical Writing
Experience Required: 2–5 Years
Job Level: Mid-Level Professional
Position Overview
The Safety Writer is responsible for the preparation, authoring, review, and management of aggregate safety reports, risk management documents, signal detection reports, and other pharmacovigilance-related regulatory documents. The role involves close collaboration with internal stakeholders, sponsors, regulatory teams, and medical experts to ensure timely delivery of high-quality safety documentation that complies with global regulatory requirements.
The successful candidate will contribute to patient safety by supporting benefit-risk evaluation activities, regulatory submissions, safety surveillance, literature monitoring, and medical communication initiatives.
Key Responsibilities
Safety Report Authoring & Regulatory Documentation
Author, review, and manage safety-related regulatory documents for global submissions.
Prepare high-quality pharmacovigilance reports in accordance with global regulatory requirements.
Ensure scientific accuracy, consistency, and compliance across all deliverables.
Key Documents Include:
Periodic Safety Update Reports (PSURs)
Periodic Benefit-Risk Evaluation Reports (PBRERs)
Development Safety Update Reports (DSURs)
Periodic Adverse Drug Experience Reports (PADERs)
Annual Reports (IND and other regulatory requirements)
Risk Management Plans (RMPs)
Signal Detection Reports
Safety Issue Analysis Reports
Benefit-Risk Evaluation Reports
Labeling Support Documentation
Safety Surveillance & Signal Management
Contribute to signal detection and signal evaluation activities.
Author periodic and ad-hoc signal reports.
Support safety surveillance initiatives by analyzing safety data and literature findings.
Assist in benefit-risk assessments and safety evaluations.
Clinical & Regulatory Writing
Prepare Common Technical Document (CTD) components, including:
Clinical Overviews
Clinical Summaries
Non-Clinical Overviews
Non-Clinical Summaries
Support preparation of regulatory submission documents.
Contribute to responses for health authorities and regulatory agencies.
Adverse Event Documentation
Write and review subject narratives for:
Serious Adverse Events (SAEs)
Adverse Drug Reactions (ADRs)
Significant Safety Events
Ensure narratives accurately reflect clinical data and regulatory expectations.
Labeling & Risk Management Support
Participate in development and maintenance of product labeling documents, including:
Company Core Data Sheets (CCDS)
US Prescribing Information (USPI)
Summary of Product Characteristics (SmPC)
Medication Guides (Med Guides)
Support safety-related labeling updates and change management activities.
Medical Information & Scientific Communication
Prepare scientifically accurate responses to healthcare professional (HCP) medical information requests.
Summarize complex clinical and safety data into clear, concise medical communications.
Support internal and external scientific discussions related to product safety.
Literature Review & Safety Intelligence
Conduct scientific literature searches and surveillance activities.
Review literature search strategies and recommend improvements.
Evaluate published scientific articles for safety relevance.
Prepare:
Literature Summaries
Safety Abstracts
Company Comments
Safety Assessments
Quality Review & Mentorship
Perform quality review of safety documents prepared by junior writers and associates.
Provide guidance and support to less experienced medical writers.
Act as co-author for complex or high-priority safety reports.
Ensure adherence to quality standards and regulatory requirements.
Project Coordination & Stakeholder Management
Lead report planning activities and kick-off meetings.
Coordinate with:
Sponsors
Pharmacovigilance Teams
Regulatory Affairs
Medical Experts
Clinical Development Teams
Manage timelines and ensure successful delivery of assigned projects.
Facilitate comment resolution meetings and stakeholder discussions.
Compliance & Process Excellence
Ensure compliance with:
ICH Guidelines
Good Pharmacovigilance Practices (GVP)
Good Clinical Practice (GCP)
Regulatory Authority Requirements
Internal SOPs
Promote process improvements and operational efficiency.
Maintain audit and inspection readiness.
Required Qualifications
Education
Mandatory
Bachelor’s Degree in:
Pharmacy (B.Pharm)
Life Sciences
Biotechnology
Biomedical Sciences
Pharmacology
Nursing
Medicine
Related Scientific Discipline
Preferred
M.Pharm
MSc (Life Sciences)
PharmD
MD
PhD
Other Advanced Scientific Degrees
Experience Requirements
Mandatory
Minimum 3 years of pharmaceutical industry experience
OR
Minimum 2 years of dedicated medical writing experience
Preferred Experience
Experience in:
Pharmacovigilance
Drug Safety
Regulatory Writing
Aggregate Safety Reporting
Signal Detection
Risk Management
Clinical Research
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