Safety Writer – Pharmacovigilance & Regulatory Medical Writing
Location: Mumbai, India
Category: Clinical / Pharmacovigilance / Medical Writing
Job ID: 254757
Experience Required: 3+ Years (Medical Writing / Pharmacovigilance)
Role Overview
We are seeking an experienced Safety Writer to support global pharmacovigilance and regulatory activities through the preparation, review, and quality oversight of aggregate safety reports, risk management documents, and signal detection deliverables. This role is critical in ensuring the timely delivery of high-quality, compliant safety documentation for global regulatory submissions.
The ideal candidate will bring strong scientific writing expertise, a deep understanding of pharmacovigilance regulations, and the ability to collaborate effectively with internal teams and global clients.
Key Responsibilities
Author, review, and manage aggregate safety and risk management documents for global regulatory submissions
Lead report planning activities, including data collection, strategy development, kick-off meetings, and comment resolution discussions
Prepare safety reports including, but not limited to:
Development Safety Update Reports (DSURs)
Periodic Safety Update Reports (PSURs)
Periodic Adverse Drug Experience Reports (PADERs)
Annual Reports (IND and non-IND)
Risk Management Plans (RMPs)
Take ownership of assigned deliverables and coordinate with internal teams and sponsors to obtain required inputs
Perform quality review and oversight of safety reports prepared by junior and associate medical writers
Author benefit–risk evaluation reports, safety issue analyses, signal detection reports, and justification documents for label updates
Prepare CTD summaries, including Clinical and Non-Clinical Overviews and Clinical Summaries
Draft subject narratives for adverse drug reactions (ADRs) and serious adverse events (SAEs)
Contribute to the creation and maintenance of product labeling, including Core Data Sheets (CDS), USPI, SmPCs, and Medication Guides
Conduct and review scientific literature searches, prepare literature abstracts/summaries, and recommend company comments
Ensure compliance with global regulatory requirements, pharmacovigilance regulations, GVP, ICH, and GCP guidelines
Support internal and external client communication to ensure timely, cost-effective, and high-quality delivery
Promote standardized, efficient, and compliant writing processes aligned with SOPs and quality standards
Qualifications
Education
Bachelor’s degree in Life Sciences or a related discipline (required)
Master’s or PhD preferred
Equivalent relevant industry experience may be considered in lieu of formal education
Professional Experience
Minimum 3 years of experience in the pharmaceutical industry, including at least 2 years in medical writing or pharmacovigilance
Demonstrated experience in writing and reviewing aggregate safety reports
Strong understanding of global regulatory requirements, pharmacovigilance practices, and ICH/GCP guidelines
Exposure to scientific or clinical research environments is desirable
Core Skills & Competencies
Excellent written and spoken English with strong scientific communication skills
High attention to detail with a strong quality and compliance mindset
Proficiency in Microsoft Office and document management systems
Strong organizational, time management, and multitasking abilities
Effective interpersonal skills with the ability to collaborate across global teams
Client-focused approach with the ability to manage multiple deliverables
Work Environment & Travel
Office-based role in Mumbai, India
Willingness to travel up to 5%, including overnight stays, based on project requirements
Why This Role
Opportunity to work on global pharmacovigilance and regulatory submissions
Exposure to complex safety writing, signal detection, and benefit–risk evaluation projects
Collaborative environment with opportunities to mentor junior writers
Career growth within medical writing and drug safety domains
Equal Employment Opportunity
The organization is committed to providing equal employment opportunity and maintaining a diverse, inclusive, and accessible workplace. Reasonable accommodations are available throughout the recruitment process.
SEO Keywords Optimized
Safety Writer Jobs, Pharmacovigilance Medical Writing Jobs, Aggregate Safety Report Writer, PSUR DSUR Writer Jobs India, Drug Safety Medical Writer Mumbai, Regulatory Safety Writing Careers
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