CS Writing Scientist

gsknch; Telangana; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Haleon in India is seeking a Consumer Safety Writing Scientist to lead planning, authoring, quality review, and delivery of pharmacovigilance aggregate safety reports in line with regulatory requirements.

You will coordinate with safety, regulatory, medical, and clinical teams to ensure timely, accurate submissions, robust benefit-risk assessment, and inspection readiness, including PSURs and other periodic reports.

Qualifications

• Bachelor's or master's degree in pharmacy, life sciences or a related field, with at least 5 years of relevant experience.
• Experience in pharmacovigilance aggregate reporting and regulatory submissions.
• Strong written English and ability to produce scientifically balanced narratives.

Responsibilities

• Plan, author, coordinate, and finalize pharmacovigilance aggregate safety reports from initiation to completion.
• Maintain current product safety knowledge and ensure consistent use of approved safety information across reports.
• Compile safety data from databases, clinical data, literature, regulatory commitments and reference documents.
• Review literature and safety information to identify topics and signals for inclusion.
• Collaborate with stakeholders to resolve content or process issues and meet timelines.
• Develop clear, scientifically balanced safety narratives and executive summaries.
• Provide aggregate reporting expertise to Consumer Safety Science for risk assessment and labeling updates.
• Maintain audit and inspection readiness with documentation and control of versions.
• Drive improvements to report writing processes, templates, and quality standards.

Skills

Excellent written English

Pharmacovigilance

Aggregate reporting

Data interpretation

Safety narratives

Education

Bachelor's or master's in pharmacy or life sciences

Job description

Welcome to Haleon. We're a purpose-driven, world-class consumer company putting everyday health in the hands of millions. In just three years since our launch, we've grown, evolved and are now entering an exciting new chapter - one filled with bold ambitions and enormous opportunity.

Our trusted portfolio of brands - including Sensodyne®, Panadol®, Advil®, Voltaren®, Theraflu®, Otrivin®, and Centrum® - lead in resilient and growing categories. What sets us apart is our unique blend of deep human understanding and trusted science.

Now it's time to fully realise the full potential of our business and our people. We do this through our Win as One strategy. It puts our purpose - to deliver better everyday health with humanity - at the heart of everything we do. It unites us, inspires us, and challenges us to be better every day, driven by our agile, performance-focused culture.

Hello. We're Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we're improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands - including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum - through a unique combination of deep human understanding and trusted science. What's more, we're achieving it in a company that we're in control of. In an environment that we're co-creating. And a culture that's uniquely ours. Care to join us. It isn't a question

About the role:

The Consumer Safety Writing Scientist leads the planning, authoring, quality review, and delivery of pharmacovigilance aggregate safety reports in line with global, regional, and local regulatory requirements. The role ensures timely, accurate, and inspection-ready submissions that support ongoing benefit-risk evaluation and fulfil Marketing Authorisation Holder obligations.

Position Purpose:

This role leads the planning, authoring, coordination, quality control, and delivery of pharmacovigilance aggregate safety reports for regulatory submission. The role holder prepares compliant, scientifically balanced, and fit-for-purpose documents, including PSURs/PBRERs, DSURs, medical device PSURs, Canadian Annual Reports, US PADERs, and other periodic or ad hoc aggregate reports, as applicable. The role requires close collaboration with Consumer Safety Science, Regulatory, Medical, Clinical, Labelling, and other contributing functions to ensure accurate safety data interpretation, robust benefit-risk assessment, and timely report delivery.

Accountabilities/Responsibilities:

• Plan, author, coordinate, and finalize pharmacovigilance aggregate safety reports from initiation to completion, ensuring scientific accuracy, regulatory compliance, and alignment with agreed timelines.
• Maintain current product safety knowledge and ensure consistent, accurate use of approved product safety information across aggregate reports and related regulatory documents.
• Compile, assess, and integrate relevant safety data from appropriate sources, including safety databases, clinical data, literature, regulatory commitments, prior aggregate reports, and approved reference documents.
• Review literature and relevant safety information to identify safety topics and potential signals requiring inclusion or discussion in aggregate reports.
• Work independently with stakeholders to resolve content or process issues, challenge inputs where appropriate, and ensure deliverables are completed in line with company procedures and regulatory expectations.
• Develop clear, scientifically balanced safety narratives, conclusions, and executive summaries that support internal decisions, external communications, regulatory responses, and aggregate report outcomes.
• Provide aggregate reporting expertise to Consumer Safety Science, contributing to benefit-risk assessments, signal evaluation outputs, labelling updates, and safety surveillance activities that inform report strategy and content.
• Maintain audit and inspection readiness for assigned reports through complete documentation, clear decision rationale, traceable data sources, controlled versions, and quality control evidence.
• Drive improvements to aggregate report writing processes, templates, quality standards, and ways of working, with a focus on consistency, efficiency, compliance, and inspection readiness.

Qualifications & Experience

Bachelor's or master's degree in pharmacy, life sciences or a related scientific discipline with a minimum of 5 years of relevant experience is preferred.

Competencies and Skills

Technical Skills

• Excellent written English, with strong scientific writing capabilities.
• Experience in preparing and reviewing pharmacovigilance aggregate reports, including PSURs/PBRERs, DSURs, or other periodic safety reports.
• Sound knowledge of pharmacovigilance principles, MedDRA terminology, medical concepts, aggregate reporting requirements, and benefit-risk evaluation.
• Able to interpret, analyze, and present safety data