Senior Safety Writer and Process Lead
Job ID: 256223
Location: Mumbai, India
Category: Clinical Research | Pharmacovigilance | Medical Writing
Employment Type: Full Time
Job Overview
We are seeking an experienced Senior Safety Writer and Process Lead to lead the end-to-end development of aggregate safety reports, risk management documentation, signal detection outputs, and benefit–risk evaluation reports for global regulatory submissions. This role requires strong pharmacovigilance domain expertise, advanced medical writing skills, and the ability to manage complex deliverables while coordinating activities across multiple writers and stakeholders.
The successful candidate will be accountable for planning, authoring, reviewing, approving, and submitting safety documents in compliance with global regulatory standards, ensuring timely delivery of high-quality outputs to internal teams and external sponsors.
Key Responsibilities
Safety and Regulatory Writing
Lead the preparation, review, and finalization of aggregate safety reports, including but not limited to:
Periodic Safety Update Reports (PSUR)
Periodic Benefit-Risk Evaluation Reports (PBRER)
Development Safety Update Reports (DSUR)
Periodic Adverse Drug Experience Reports (PADER)
Annual Reports (IND and non-IND)
Bridging and ad hoc safety reports
Author and review Risk Management Plans (RMPs), safety update reports, benefit–risk evaluations, addendum reports, and supporting documentation.
Develop Common Technical Document (CTD) summaries, including Clinical Overviews, Non-Clinical Overviews, and Clinical Summaries.
Generate and review line listings, summary tabulations, CFIs, and CFCs.
Labeling and Medical Information
Create, review, and update regulatory labeling documents, including Core Data Sheets (CDS), USPI, SmPCs, and Medication Guides.
Conduct comprehensive literature searches, evaluate emerging safety data, recommend labeling updates, and prepare justification documents.
Prepare medical information responses for healthcare professionals (HCPs).
Process Leadership and Team Coordination
Coordinate report-writing activities across a team of safety and medical writers, including workload allocation, scheduling, and progress tracking.
Act as a writing coach and mentor, supporting quality, consistency, and professional development across the team.
Serve as the primary point of contact for clients for all safety writing–related activities.
Ensure effective internal and external communication to obtain inputs, resolve issues, and maintain project timelines.
Quality, Compliance, and Operational Excellence
Perform and document quality checks, maintain metrics, and support training initiatives.
Assist with resource planning, effort estimation, and RFP responses.
Implement and promote standardized, efficient, and compliant writing processes aligned with SOPs and regulatory expectations.
Ensure full compliance with global regulatory requirements, Good Pharmacovigilance Practices (GVP), and ICH GCP guidelines.
Required Qualifications and Experience
Education
Bachelor’s degree in Life Sciences or a related discipline (minimum requirement)
Equivalent relevant experience may be considered in lieu of formal education
Advanced degree (Master’s or PhD) preferred
Experience
5–7 years of experience in the pharmaceutical or life sciences industry, or
Minimum 4 years of experience in medical or safety writing
Demonstrated experience in aggregate safety reporting and pharmacovigilance
Exposure to drug development, safety surveillance, and benefit–risk management preferred
Skills and Competencies
Excellent command of written and spoken English
Strong scientific writing, editing, and review capabilities
In-depth knowledge of pharmacovigilance regulations, drug safety reporting, and benefit–risk assessment
Solid understanding of anatomy, physiology, disease states, and medical treatments
Proficiency in MS Office applications
Strong organizational, time management, and multitasking skills
Excellent interpersonal and stakeholder management abilities
Ability to manage medium- to high-complexity projects with minimal supervision
Work Environment and Travel
Mumbai-based role with client office and/or home-based work options depending on project requirements
Willingness to travel up to 10%, including overnight stays, as needed
Equal Employment Opportunity
The organization is committed to providing equal employment opportunities and supports reasonable accommodations in accordance with applicable laws.
Keywords for SEO & GPT Optimization:
Senior Safety Writer jobs, Pharmacovigilance Medical Writing, Aggregate Safety Reports, PSUR PBRER DSUR, Risk Management Plans, Drug Safety Writing Jobs India, Clinical Regulatory Writing, ICH GCP, Benefit Risk Evaluation, Mumbai Clinical Jobs
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