Safety Writer – Mumbai, India
Job ID: 254757
Category: Clinical / Medical Writing
Location: Mumbai, India
About the Role
We are seeking an experienced Safety Writer to join our clinical operations team in Mumbai. This role is responsible for the preparation, review, and quality oversight of aggregate safety, risk management, and signal detection documents for global regulatory submissions. The ideal candidate will have 3+ years of experience in the pharmaceutical industry, with 2+ years in medical writing, strong knowledge of pharmacovigilance practices, and familiarity with ICH-GCP and regulatory requirements.
The Safety Writer will collaborate with internal teams and clients, ensuring timely, high-quality deliverables while maintaining compliance with regulatory standards and internal SOPs.
Key Responsibilities
Author and review safety reports for regulatory submissions, including:
Periodic Safety Update Reports (PSUR)
Development Safety Update Reports (DSUR)
Annual Reports (IND and other)
Periodic Adverse Drug Experience Reports (PADER)
Risk Management Plans (RMP)
Provide oversight and quality review of reports prepared by junior writers or peers.
Contribute to ad hoc reports, benefit-risk evaluations, label update justifications, and supporting documents.
Author subject narratives for adverse drug reactions (ADRs) and serious adverse events (SAEs).
Prepare Common Technical Document (CTD) summaries, including Clinical and Non-Clinical Overviews.
Conduct scientific literature searches for routine surveillance and report authoring; review and summarize articles.
Collaborate with internal and external stakeholders to collect required data and inputs.
Assist in creating and updating product labels, including Core Data Sheets, USPI, and SmPCs.
Implement efficient and consistent processes to ensure timely and high-quality deliverables.
Ensure compliance with all regulatory requirements, pharmacovigilance standards, and internal SOPs.
Qualifications & Experience
Education:
Bachelor’s degree in Life Sciences, Pharmacy, or related field required.
Advanced degrees (MSc, PhD) are preferred.
Relevant experience may be considered in lieu of formal education.
Experience:
Minimum 3 years in the pharmaceutical industry, with at least 2 years in medical writing.
Strong knowledge of pharmacovigilance, ICH-GCP guidelines, and regulatory requirements.
Scientific or clinical research experience is desirable.
Skills & Competencies:
Excellent written and verbal English communication skills.
Proficiency in MS Office applications.
Strong organizational, analytical, and time-management skills.
Ability to work collaboratively and independently in a matrix team environment.
Attention to detail and commitment to high-quality outputs.
Work Environment
Office-based role in Mumbai, India.
Available for travel up to 5% as project requirements dictate.
Why Join Us
Opportunity to work in a dynamic, client-focused environment in clinical safety and medical writing.
Gain exposure to global pharmacovigilance and regulatory practices.
Career growth in a leading pharmaceutical and clinical operations company.
Collaborative and professional workplace promoting innovation, quality, and excellence.
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