Senior Safety Writer and Process Lead
Location: Mumbai, India
Employment Type: Full-time
Job Requisition ID: 256223
Category: Drug Safety / Pharmacovigilance / Medical Writing
Role Overview
The Senior Safety Writer and Process Lead is a critical leadership role responsible for the end-to-end planning, authoring, review, and submission of complex aggregate safety and benefit-risk documents for global regulatory submissions. This role combines deep pharmacovigilance expertise with process leadership, team coordination, and quality oversight to ensure timely, compliant, and high-quality safety deliverables.
The position serves as a primary point of contact for clients and internal stakeholders, supports multiple report types across products, and mentors medical writers while driving efficient, standardized safety writing processes.
Key Responsibilities
Safety Writing & Regulatory Documentation
Lead the preparation, review, and management of aggregate safety reports, including:
Periodic Safety Update Reports (PSUR) / Periodic Benefit-Risk Evaluation Reports (PBRER)
Periodic Adverse Drug Experience Reports (PADER)
Development Safety Update Reports (DSUR)
Annual Reports (IND and other regional formats)
Signal detection, benefit-risk evaluation, bridging, addendum, and ad hoc safety reports
Author and review Risk Management Plans (RMPs), safety updates, and supporting regulatory documentation.
Prepare Common Technical Document (CTD) summaries, including Clinical and Non-Clinical Overviews and Summaries.
Develop and maintain product labeling documents such as Core Data Sheets (CDS), US Prescribing Information (USPI), centralized SPCs, Medication Guides, and related safety updates.
Conduct literature searches to support safety assessments, labeling updates, and benefit-risk evaluations, including preparation of justification and supporting documents.
Process Leadership & Team Coordination
Lead and coordinate safety writing activities across a team of writers, including work allocation, scheduling, and progress tracking.
Act as a writing coach and mentor to support skill development and quality improvement.
Serve as the primary client contact for safety writing deliverables, ensuring alignment with scope, timelines, and quality expectations.
Support resource planning, effort estimation, and responses to RFPs and proposal activities.
Track metrics, perform and document quality checks, and support training initiatives.
Identify, escalate, and resolve issues impacting project delivery and timelines.
Compliance & Quality Oversight
Ensure compliance with global regulatory requirements, pharmacovigilance regulations, and internal SOPs.
Promote standardized, efficient, and high-quality safety writing processes across projects.
Maintain accountability for deliverables and inspection-ready documentation at all times.
Required Qualifications & Experience
Education
Bachelor’s degree in Life Sciences or a related discipline.
Equivalent professional experience may be considered in lieu of formal education.
Experience
5–7 years of experience in the pharmaceutical or life sciences industry, or
Minimum 4 years of dedicated medical or safety writing experience.
Experience in pharmacovigilance and drug safety reporting is strongly preferred.
Exposure to drug discovery, clinical research, or regulatory writing is desirable.
Core Skills & Competencies
Excellent written and spoken English communication skills.
Strong knowledge of global pharmacovigilance regulations, ICH guidelines, and GCP.
Thorough understanding of drug safety, signal detection, and benefit-risk assessment.
Solid grounding in anatomy, physiology, disease states, and medical treatments.
Proficiency in Microsoft Office applications.
Strong organizational, time-management, and interpersonal skills.
Ability to manage multiple deliverables in a fast-paced, client-focused environment.
Preferred Qualifications
Advanced degree (Master’s or PhD) in life sciences, pharmacy, or a related discipline.
Work Environment & Travel
Client-site, office-based, or home-based work arrangement depending on project requirements.
Willingness to travel up to 10%, including occasional overnight stays, based on project needs.
Equal Opportunity Statement
The organization is committed to equal employment opportunities and providing reasonable accommodations throughout the recruitment process.
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