Senior Safety Writer And Process Lead

Fortrea

5-7 years

preferred by company

India Mumbai

10 Jan. 19, 2026

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Safety Writer & Process Lead – Pharmacovigilance

Location: Mumbai, India
Job Type: Full-Time
Experience Required: 5–7 years in pharmaceutical or medical writing; 4+ years in safety/medical writing preferred
Job ID: 256223

Role Overview

We are seeking a Senior Safety Writer & Process Lead to join our Mumbai team, specializing in pharmacovigilance and regulatory safety documentation. This role combines expert medical writing skills with process management to ensure the creation, review, and delivery of high-quality safety, risk management, and benefit-risk evaluation reports for global regulatory submissions.

The ideal candidate will have strong experience in drug safety and pharmacovigilance, a thorough understanding of regulatory requirements, and the ability to manage multiple deliverables and cross-functional teams efficiently.

Key Responsibilities

Lead end-to-end preparation and review of complex safety documents, including:
- Periodic Safety Update Reports (PSURs)
- Periodic Benefit-Risk Evaluation Reports (PBRERs)
- Development Safety Update Reports (DSURs)
- Common Technical Document (CTD) summaries and bridging documents
- Risk Management Plans (RMPs) and associated regulatory reports
Author and review medical information responses for healthcare professionals (HCPs).
Act as a writing coach and mentor to junior writers, supporting onboarding and training.
Coordinate team activities for report writing, including resource allocation, scheduling, and communication with internal and external stakeholders.
Conduct literature searches for authoring reports, label changes, and safety updates.
Prepare and maintain labels and core safety documents, including Core Data Sheets, USPI, SPCs, and Medication Guides.
Ensure compliance with regulatory standards, ICH GCP guidelines, and Good Pharmacovigilance Practices.
Maintain metrics, documentation, and quality checks to ensure timely and accurate deliverables.
Support client communications, manage queries, and provide status updates on project deliverables.
Contribute to process improvements, SOP implementation, and efficiency initiatives in safety writing and report management.

Required Qualifications & Skills

Education: Bachelor’s degree in Life Sciences, Pharmacy, or equivalent. Advanced degree (MSc, PhD) preferred.
Experience:
- 5–7 years in pharmaceutical industry, pharmacovigilance, or medical writing.
- Minimum 4 years specifically in medical safety writing.
Strong understanding of drug safety, benefit-risk assessment, and pharmacovigilance processes.
Knowledge of regulatory submission requirements and global safety reporting standards.
Excellent command of written and spoken English, with strong scientific writing skills.
Proficiency in Microsoft Office and standard documentation tools.
Strong organizational, time management, and interpersonal skills.
Ability to mentor junior team members and coordinate cross-functional teams effectively.

Preferred Skills

Experience in drug discovery or clinical research.
Strong working knowledge of anatomy, physiology, disease states, and medical treatments.
Familiarity with global regulatory frameworks and safety databases.
Ability to travel up to 10% for client or project-related requirements.

Work Environment

Hybrid work model: client office as per assignment and/or home-based office.
Travel requirements: up to 10%, including overnight stays.

SEO & GEO Optimized Keywords:
Senior Safety Writer Mumbai, Pharmacovigilance Lead India, Regulatory Safety Reports, PBRER & DSUR Author, PV Process Lead, Medical Writing Jobs Mumbai

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Senior Safety Writer And Process Lead

Job Description

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