CS Writing Scientist

Haleon; Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Haleon in Hyderabad is seeking a Consumer Safety Writing Scientist to lead planning, authoring, and quality review of pharmacovigilance aggregate safety reports for regulatory submission. You will ensure timely, inspection-ready PSURs, DSURs, and other reports, collaborating with safety, regulatory, medical, and clinical teams.

We require a strong pharmacovigilance writing background, excellent English, and the ability to craft scientifically balanced narratives and executive summaries to

Qualifications

• Bachelor’s or master’s degree in pharmacy, life sciences or related field with 5+ years of relevant experience preferred.
• Proven experience writing pharmacovigilance aggregate reports (PSURs, PBRERs, DSURs) and related documents.
• Strong knowledge of MedDRA terminology and safety data interpretation.

Responsibilities

• Plan, author, coordinate, and finalize pharmacovigilance aggregate safety reports from initiation to completion.
• Maintain current product safety knowledge and ensure consistent use of safety information across reports.
• Review literature and data sources to identify safety topics and signals for reports.
• Develop clear safety narratives, conclusions, and executive summaries for regulatory use.
• Ensure audit readiness with thorough documentation and traceable data sources.

Skills

Excellent written English

Pharmacovigilance writing

PSURs/PBRERs/DSURs experience

MedDRA terminology

Executive summaries

Stakeholder engagement

Microsoft Office

Education

Bachelor’s or Master’s degree in pharmacy or life sciences

Tools

Microsoft Office

MedDRA usage

Job description

Welcome to Haleon

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:

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 clearly to support robust aggregate report conclusions. Broad understanding of pharmacovigilance activities, with sound documentation practices. Proficient in Microsoft Office tools.

Soft Skills Strong communication and stakeholder engagement skills. Able to work independently with limited supervision. Able to manage multiple report deliverables, competing priorities, stakeholder inputs, and regulatory deadlines while maintaining quality and attention to detail. Self-motivated, adaptable, and responsive to changing timelines and business priorities.

Job Posting End Date 2026-09-15

Equal Opportunities

Equal Opportunities Haleon are committed to mobilising our purpose in a way that represents the diverse consumers and communities who rely on our brands every day. It guides us in creating an inclusive culture, where different backgrounds and views are valued and respected – all in support of understanding and best serving the needs of our consumers and unleashing the full potential of our people. It’s important to us that Haleon is a place where all our employees feel they truly belong. During the application process, we may ask you to share some personal information, which is entirely voluntary. This information ensures we meet certain regulatory and reporting obligations and supports the development, refinement, and execution of our inclusion and belonging programmes that are open to all Haleon employees. The personal information you provide will be kept confidential, used only for legitimate business purposes, and will never be used in making any employment decisions, including hiring decisions.

Adjustment or Accommodations Request

If you require a reasonable adjustment or accommodation or other assistance to apply for a job at Haleon at any stage of the application process, please let your recruiter know by providing them with a description of specific adjustments you are requesting. We’ll provide all reasonable adjustments to support you throughout the recruitment process and treat all information you provide us in confidence.

Note to candidates

The Haleon recruitment team will contact you using a Haleon email account (@haleon.com). If you are not sure whether the email you received is from Haleon, please get in touch.

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.