CS Writing Scientist

Haleon plc.; Hyderabad; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

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

The role involves coordinating with safety, regulatory, medical and clinical teams to ensure accurate data interpretation and timely submissions that support benefit-risk evaluation and regulatory obligations.

Qualifications

• Bachelor’s or master’s degree in pharmacy, life sciences or related field with at least 5 years of relevant experience preferred.
• Experience in preparing and reviewing pharmacovigilance aggregate reports (PSURs/PBRERs, DSURs or other safety reports).
• Sound knowledge of pharmacovigilance principles, MedDRA terminology and benefit-risk assessment.

Responsibilities

• Plan, author, coordinate and finalize pharmacovigilance aggregate safety reports from start to finish.
• Ensure regulatory compliance, scientific accuracy and timely delivery aligned with timelines.
• Develop clear safety narratives and executive summaries for internal and regulatory use.

Skills

Pharmacovigilance reporting

MedDRA knowledge

Scientific writing

Data interpretation

Regulatory compliance

Stakeholder engagement

Independent work

Time management

Education

Bachelor’s or Master’s in Pharmacy / Life Sciences

Tools

Microsoft Office

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 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

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.

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.