Job Title: Principal Safety Writer – Pharmacovigilance & Medical Writing
Location: Mumbai, India
Employment Type: Full-Time
Work Mode: Office-based / Remote (as per project needs)
Application Deadline: January 16, 2026
Job Requisition ID: 2634
Job Overview
We are seeking an experienced Principal Safety Writer to lead global pharmacovigilance writing activities, including aggregate safety reporting, risk management, signal detection, and benefit–risk evaluation. This senior-level role requires independent ownership of complex safety deliverables, technical leadership of medical writing teams, and direct client engagement across global projects.
The successful candidate will act as a technical and scientific lead, ensuring high-quality, compliant, and timely safety documentation while driving process improvements, mentoring writers, and contributing to scientific publications and regulatory strategy.
Key Responsibilities
Safety Writing & Regulatory Leadership
Lead authoring and review of aggregate safety reports for global regulatory submissions, including:
Annual Reports (IND and non-IND)
Periodic Safety Update Reports (PSURs)
Periodic Adverse Drug Experience Reports (PADERs)
Development Safety Update Reports (DSURs)
Clinical Overviews and Medical Device Safety Reports
Ensure end-to-end management of safety deliverables, maintaining quality standards and meeting regulatory timelines.
Provide technical oversight to co-authors and writing teams and assume accountability for overall document quality.
Client & Stakeholder Management
Act as the primary client contact for report management and safety writing activities.
Manage stakeholder expectations, proactively identify risks, propose mitigation strategies, and escalate critical issues when required.
Participate in safety and benefit–risk review meetings with clients and cross-functional stakeholders.
Signal Management & Benefit–Risk Evaluation
Lead and contribute to signal detection and signal management activities, including strategy development and data retrieval from safety databases and scientific literature.
Author and review signal evaluation reports, safety issue analyses, and benefit–risk evaluation documents.
Collaborate with safety physicians to propose label updates and risk minimization measures.
Scientific Publications & Medical Communication
Develop abstracts, posters, manuscripts, and presentations for scientific conferences and pharmacovigilance forums.
Prepare medical information responses for healthcare professionals (HCPs).
Draft and support responses to health authority questions and regulatory feedback.
Leadership, Quality & Process Excellence
Act as a writing coach and mentor, providing feedback, training, and best practice guidance to medical writers.
Support project management activities including schedule tracking, metrics, and compliance monitoring.
Drive continuous improvement initiatives related to quality, efficiency, and regulatory compliance.
Contribute to business development activities such as resource estimation and RFP responses.
Additional Responsibilities
Create and update product labels including Core Data Sheets (CDS), USPI, centralized SPCs, and Medication Guides.
Conduct comprehensive literature reviews and execute advanced search strategies for complex scientific topics.
Ensure compliance with global regulatory requirements and internal SOPs.
Represent the organization at scientific meetings and conferences when required.
Qualifications
Education
Bachelor’s degree in Life Sciences or related discipline (minimum requirement)
Equivalent relevant experience may be considered in lieu of formal education
Advanced degree (Master’s or PhD) preferred
Experience Required
5–7 years of experience in the pharmaceutical or CRO industry
Minimum 4 years of hands-on medical or safety writing experience
Strong expertise in pharmacovigilance, regulatory submissions, and benefit–risk assessment
Proven experience leading teams, mentoring writers, and managing complex safety deliverables
Core Skills & Competencies
Excellent command of written and spoken English
In-depth knowledge of ICH, GCP, GVP, and global regulatory requirements (US, EU, emerging markets)
Strong understanding of the pharmaceutical product development lifecycle
Ability to work independently and lead cross-functional teams
High level of organizational, leadership, and stakeholder management skills
Proficiency in Microsoft Office applications
Preferred Experience
Experience in drug discovery and pharmacovigilance
Scientific or clinical research background
Exposure to global regulatory interactions and inspections
Work Environment & Travel
Office-based or remote work model
Willingness to travel up to 15%, including overnight stays, as required by project needs
Why Join This Role
This role offers a strategic leadership opportunity to shape global safety narratives, influence regulatory decision-making, mentor the next generation of medical writers, and contribute to scientific excellence in pharmacovigilance.
Apply now on thepharmadaily.com to advance your career as a Principal Safety Writer in global pharmacovigilance and regulatory medical writing.
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