Safety Writer – Pharmacovigilance & Medical Writing
Location: Mumbai, India
Employment Type: Full-Time
Application Deadline: March 23, 2026
Experience Required: Minimum 3+ years in the pharmaceutical industry, including at least 2 years in medical writing or drug safety writing
Job Overview
We are seeking a highly skilled Safety Writer to support pharmacovigilance and regulatory medical writing activities. This role focuses on the preparation, review, and management of aggregate safety reports, risk management documents, and signal detection outputs for global regulatory submissions.
The ideal candidate will have strong expertise in safety writing, benefit-risk evaluation, and regulatory documentation, along with the ability to collaborate with cross-functional stakeholders and deliver high-quality outputs within strict timelines.
Key Responsibilities
Prepare and review aggregate safety reports including Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), Periodic Adverse Drug Experience Reports (PADERs), Annual Reports (IND), and Risk Management Plans (RMPs)
Lead report planning activities including data collection, strategy development, and stakeholder alignment meetings
Perform quality review and provide oversight for reports developed by junior or associate medical writers
Author benefit-risk evaluation reports, signal detection reports, safety issue analyses, and regulatory justification documents
Develop Common Technical Document (CTD) summaries including clinical overviews and summaries
Write subject narratives for adverse events (AEs) and serious adverse events (SAEs)
Support labeling activities including Core Data Sheets (CDS), USPI, Summary of Product Characteristics (SmPC), and Medication Guides
Conduct scientific literature searches, evaluate publications, and prepare summaries with company insights
Respond to medical information queries from healthcare professionals
Ensure compliance with global regulatory requirements, pharmacovigilance practices, and ICH-GCP guidelines
Coordinate with internal teams and clients to ensure timely delivery of high-quality documents
Drive process improvements and maintain high standards of documentation quality and efficiency
Required Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, or a related discipline
Strong knowledge of pharmacovigilance, regulatory writing, and clinical research processes
Excellent written and verbal communication skills in English
Proficiency in Microsoft Office tools
Preferred Qualifications
Master’s degree or PhD in Life Sciences or related field
Experience in scientific or clinical research environments
Strong understanding of global regulatory guidelines and safety reporting requirements
Key Skills and Competencies
Strong analytical and scientific writing skills
Excellent organizational and time management abilities
Ability to manage multiple deliverables and meet strict timelines
Effective stakeholder communication and collaboration skills
Attention to detail with a focus on quality and compliance
Work Environment and Expectations
Office-based role in Mumbai with minimal travel requirements (up to 5%)
Collaborative, fast-paced environment with exposure to global regulatory projects
Why Apply
This role offers an excellent opportunity to build advanced expertise in pharmacovigilance and regulatory medical writing, working on global safety submissions and contributing to patient safety and compliance in the pharmaceutical industry.
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