Job Title: Safety Writer – Pharmacovigilance & Regulatory Writing
Location: Mumbai / Pune, India
Work Mode: Hybrid
Employment Type: Full-Time
Application Deadline: January 17, 2026
Job Requisition ID: 2637
Job Overview
We are seeking an experienced Safety Writer to support global pharmacovigilance and regulatory activities through the preparation, review, and management of aggregate safety documents. This role is critical in ensuring high-quality, compliant safety deliverables for global regulatory submissions while leading client communications and mentoring junior writers.
The ideal candidate will bring strong scientific writing expertise, regulatory knowledge, and the ability to manage complex safety documentation within strict timelines.
Key Responsibilities
Author, review, and manage aggregate safety and risk management documents for global regulatory submissions, including:
Periodic Safety Update Reports (PSURs)
Periodic Adverse Drug Experience Reports (PADERs)
Development Safety Update Reports (DSURs)
Risk Management Plans (RMPs)
Annual Reports (IND and non-IND)
Lead report planning activities, data collection, kick-off meetings, and comment resolution discussions.
Perform quality review and provide oversight for safety reports authored by junior and associate medical writers.
Act as co-author for complex, high-impact, or large safety reports.
Author benefit-risk evaluations, signal detection reports, safety issue analyses, and justification documents for label updates.
Prepare adverse event and serious adverse event narratives.
Contribute to labeling activities including Core Data Sheets (CDS), USPI, SmPCs, and Medication Guides.
Conduct scientific literature searches, review selected publications, and prepare literature summaries and company comments.
Prepare medical information responses for healthcare professionals (HCPs).
Ensure compliance with regulatory requirements, pharmacovigilance standards, SOPs, and ICH-GCP guidelines.
Manage internal and external (client) communication to ensure timely delivery of high-quality safety documents.
Support continuous process improvement initiatives and promote consistency, efficiency, and quality in safety writing operations.
Qualifications & Experience
Education:
Bachelor’s degree in Life Sciences or equivalent (required)
Advanced degree (Master’s or PhD) preferred
Experience Required:
Minimum 3+ years of experience in the pharmaceutical or life sciences industry
At least 2+ years of hands-on experience in medical writing, preferably safety or pharmacovigilance writing
Skills & Competencies
Excellent written and spoken English with strong scientific writing skills
Solid understanding of global regulatory requirements, pharmacovigilance practices, and ICH-GCP guidelines
Strong organizational and time management abilities
Proficiency in Microsoft Office applications
Ability to manage multiple deliverables and meet tight regulatory timelines
Strong interpersonal and client-facing communication skills
Prior experience in clinical research or drug safety is an advantage
Work Environment & Additional Information
Hybrid working model (Mumbai or Pune office)
Up to 5% travel may be required based on project needs
Equal Opportunity Employer with a strong commitment to inclusion and accessibility
Why This Role Matters
This position offers the opportunity to work on global safety submissions, collaborate with cross-functional stakeholders, and contribute directly to patient safety and regulatory compliance across international markets.
Apply Now on thepharmadaily.com to advance your career in pharmacovigilance and regulatory medical writing.
Gujarat :
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Brussels |Antwerp :
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Zaventem |South America :
Peru | Argentina |Brazil :
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Athens | Koropi |Greece :
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Auckland |New Zealand :
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Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Hanoi | Hà Nội |Ho Chi Minh :
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Japan | Saitama |Tokyo :
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South Africa | Midrand |Nišava District :
Niš |Bohemia :
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