Job Title: Senior Safety Writer and Process Lead
Location: Mumbai, India
Employment Type: Full-Time
Work Mode: Office-based / Hybrid (as per project requirement)
Job Requisition ID: 256223
Job Overview
We are seeking an experienced Senior Safety Writer and Process Lead to lead the preparation, review, and lifecycle management of complex aggregate safety, risk management, signal detection, and benefit–risk evaluation documents for global regulatory submissions.
In this leadership role, you will oversee end-to-end safety report execution, guide and mentor a team of medical writers, ensure compliance with global pharmacovigilance regulations, and act as the primary point of contact for client-facing safety writing activities. The position requires deep domain expertise in drug safety, pharmacovigilance, and regulatory medical writing, combined with strong process and people leadership skills.
Key Responsibilities
Safety Writing & Regulatory Deliverables
Lead planning, authoring, review, approval, and submission of medium- to high-complexity safety reports in accordance with project scope and timelines.
Author and review aggregate safety and regulatory documents including:
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 non-IND)
Risk Management Plans (RMPs) and addenda
Bridging reports and ad hoc safety documents
Prepare Common Technical Document (CTD) summaries, including Clinical and Non-Clinical Overviews and Summaries.
Support benefit–risk evaluations, signal detection reports, safety updates, and justification documents for regulatory actions.
Create and maintain product labeling documents such as Core Data Sheets (CDS), USPI, centralized SPCs, and Medication Guides.
Process Leadership & Team Coordination
Act as a process lead, coordinating multiple safety writing activities across a team of writers.
Provide schedule oversight, workload allocation, and cross-functional coordination for data collection and report inputs.
Serve as a writing coach and mentor, supporting capability development of junior and mid-level medical writers.
Perform and document quality checks, maintain metrics, and support continuous process improvement initiatives.
Assist with resource estimation and RFP responses related to safety writing deliverables.
Client & Stakeholder Management
Serve as the primary client contact for safety writing activities, ensuring alignment on scope, expectations, and timelines.
Manage internal and external communications to resolve issues impacting deliverables.
Ensure consistent, high-quality service delivery in a cost-effective and timely manner.
Literature & Scientific Support
Lead and oversee scientific literature searches, evaluation of safety-relevant publications, and preparation of summaries.
Recommend labeling changes based on emerging safety data and prepare supporting justification documentation.
Qualifications & Experience
Education
Bachelor’s degree in Life Sciences or an equivalent scientific discipline
Equivalent relevant experience may be considered in lieu of formal education
Experience Required
5–7 years of experience in the pharmaceutical or CRO industry
Minimum 4+ years of hands-on experience in medical writing, with a strong focus on pharmacovigilance and safety writing
Demonstrated experience leading aggregate safety reports and complex regulatory deliverables
Exposure to drug discovery and pharmacovigilance environments is highly desirable
Core Competencies & Skills
Excellent command of written and spoken English
Strong knowledge of global pharmacovigilance regulations, GVPs, and ICH-GCP guidelines
Thorough understanding of drug safety, benefit–risk assessment, and signal management
Strong foundation in anatomy, physiology, disease states, and therapeutic interventions
Proven organizational, time management, and multitasking abilities
High attention to detail with strong quality review skills
Proficiency in Microsoft Office applications
Excellent interpersonal and stakeholder communication skills
Preferred Qualifications
Advanced degree (Master’s or PhD) in Life Sciences, Pharmacy, or related discipline
Work Environment & Travel
Office-based or home-based work model, depending on client assignment
Up to 10% travel, including overnight stays, based on project requirements
Why Join This Role
This position offers an opportunity to lead high-impact global safety writing programs, influence pharmacovigilance processes, and mentor future safety writers while working on complex regulatory submissions that directly impact patient safety worldwide.
Apply now on thepharmadaily.com to advance your career in pharmacovigilance medical writing, safety leadership, and regulatory strategy.
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