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Cs Writing Scientist

Haleon
5+ years
Not Disclosed
Hyderabad
15 Sept. 10, 2026
Job Description
Job Type: Full Time, Hybrid Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Basic Statistics Interpretation, Clinical Research Knowledge, Evidence Synthesis, Literature Review, Medical Writing, MS Word, Narrative Writing, Scientific Writing

CS Writing Scientist

Job Details

  • Company: Haleon

  • Location: Hyderabad Connaissance Park, Hyderabad, India

  • Employment Type: Full-time

  • Job Requisition ID: 547536

  • Job Posting End Date: September 15, 2026

  • Functional Area: Consumer Safety / Pharmacovigilance

  • Preferred Experience: Minimum 5 years of relevant experience

  • Preferred Qualification: Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related scientific discipline

Role Overview

The Consumer Safety Writing Scientist is responsible for planning, authoring, coordinating, quality reviewing, and delivering pharmacovigilance aggregate safety reports in accordance with global, regional, and local regulatory requirements.

The role ensures that safety reports are scientifically accurate, balanced, compliant, timely, and inspection-ready. The position supports ongoing benefit-risk evaluation and helps fulfil Marketing Authorisation Holder (MAH) pharmacovigilance obligations.

Position Purpose

The role leads the end-to-end preparation and delivery of pharmacovigilance aggregate safety reports for regulatory submission.

The position holder will prepare scientifically balanced, compliant, and fit-for-purpose safety documents, including:

  • Periodic Safety Update Reports (PSURs)

  • Periodic Benefit-Risk Evaluation Reports (PBRERs)

  • Development Safety Update Reports (DSURs)

  • Medical Device Periodic Safety Update Reports

  • Canadian Annual Reports

  • US Periodic Adverse Drug Experience Reports (PADERs)

  • Other periodic or ad hoc aggregate safety reports, as applicable

The role requires close collaboration with Consumer Safety Science, Regulatory Affairs, Medical, Clinical, Labelling, and other contributing functions to ensure accurate safety data interpretation, robust benefit-risk assessment, and timely report completion.

Key Responsibilities

Aggregate Safety Report Management

  • Plan, author, coordinate, review, and finalize pharmacovigilance aggregate safety reports from initiation through completion.

  • Ensure scientific accuracy and regulatory compliance of assigned reports.

  • Deliver reports according to agreed timelines and business requirements.

  • Coordinate contributions from relevant internal stakeholders.

  • Ensure reports are complete, consistent, scientifically balanced, and fit for regulatory submission.

  • Manage multiple aggregate reporting deliverables simultaneously.

Safety Data Compilation and Assessment

  • Compile, assess, and integrate relevant safety data from multiple sources.

  • Review information from:

    • Safety databases

    • Clinical data

    • Scientific literature

    • Regulatory commitments

    • Previous aggregate reports

    • Approved reference documents

  • Assess safety information for relevance, consistency, and completeness.

  • Interpret safety data to support aggregate report conclusions.

  • Identify relevant safety information requiring discussion within aggregate reports.

Literature Review and Signal Identification

  • Review scientific literature and relevant safety information.

  • Identify emerging safety topics and potential signals.

  • Determine whether identified safety information requires inclusion or discussion in aggregate reports.

  • Support safety signal evaluation through appropriate data interpretation.

  • Collaborate with Consumer Safety Science and other functions on emerging safety concerns.

Scientific Writing

  • Develop clear and scientifically balanced safety narratives.

  • Prepare executive summaries and report conclusions.

  • Present complex safety information in a clear and scientifically appropriate manner.

  • Ensure conclusions are supported by available safety data.

  • Provide scientifically sound content for:

    • Aggregate safety reports

    • Regulatory responses

    • Internal decision-making

    • External communications

    • Benefit-risk assessments

Benefit-Risk Evaluation

  • Provide aggregate reporting expertise to Consumer Safety Science.

  • Contribute to benefit-risk assessments.

  • Support evaluation of safety signals and safety topics.

  • Contribute to safety surveillance activities.

  • Support labelling updates where safety information impacts product information.

  • Ensure aggregate report strategy and content appropriately reflect the overall benefit-risk profile.

Product Safety Knowledge

  • Maintain current knowledge of assigned products and their safety profiles.

  • Ensure consistent and accurate use of approved product safety information.

  • Apply approved safety information consistently across aggregate reports and related regulatory documents.

  • Maintain awareness of relevant product-specific regulatory and safety requirements.

Quality Control and Inspection Readiness

  • Maintain audit and inspection readiness for assigned reports.

  • Ensure complete and traceable documentation.

  • Maintain clear rationale for key decisions and conclusions.

  • Ensure data sources are appropriately documented and traceable.

  • Maintain controlled document versions.

  • Ensure appropriate quality control evidence is available.

  • Ensure assigned reports meet company quality standards and regulatory expectations.

Stakeholder Management

  • Collaborate closely with Consumer Safety Science.

  • Work with Regulatory Affairs on regulatory requirements and submissions.

  • Collaborate with Medical and Clinical functions on scientific and clinical content.

  • Work with Labelling teams when safety information affects product labelling.

  • Coordinate with other contributing functions to obtain required data and inputs.

  • Independently resolve content and process issues with stakeholders.

  • Challenge stakeholder inputs when scientifically or procedurally appropriate.

  • Ensure stakeholder contributions are delivered within agreed timelines.

Process Improvement

  • Drive improvements in aggregate report writing processes.

  • Improve report templates and quality standards.

  • Develop and promote consistent ways of working.

  • Identify opportunities to improve efficiency and quality.

  • Support initiatives focused on:

    • Consistency

    • Efficiency

    • Compliance

    • Quality

    • Inspection readiness

Regulatory and Compliance Responsibilities

  • Ensure aggregate reports comply with applicable global, regional, and local regulatory requirements.

  • Maintain awareness of aggregate reporting expectations.

  • Ensure reports fulfil Marketing Authorisation Holder pharmacovigilance obligations.

  • Support timely regulatory submission of assigned reports.

  • Ensure report content is scientifically balanced and supported by appropriate evidence.

  • Maintain appropriate documentation for regulatory and inspection purposes.

Required Qualifications

  • Bachelor’s degree in Pharmacy, Life Sciences, or a related scientific discipline; or

  • Master’s degree in Pharmacy, Life Sciences, or a related scientific discipline.

Required Experience

  • Minimum 5 years of relevant professional experience is preferred.

  • Experience in pharmacovigilance and drug safety is highly relevant.

  • Experience preparing and reviewing pharmacovigilance aggregate safety reports.

  • Experience with periodic safety reporting and safety data analysis.

  • Experience working with cross-functional stakeholders in a regulated pharmaceutical or healthcare environment.

Technical Skills

  • Strong pharmacovigilance knowledge.

  • Experience with aggregate safety reporting.

  • Knowledge of PSUR/PBRER preparation and review.

  • Knowledge of DSURs and other periodic safety reports.

  • Understanding of medical device safety reporting is advantageous.

  • Knowledge of pharmacovigilance principles.

  • Knowledge of MedDRA terminology.

  • Understanding of medical and clinical concepts.

  • Knowledge of aggregate reporting requirements.

  • Understanding of benefit-risk evaluation.

  • Ability to interpret and analyze safety data.

  • Ability to identify and evaluate safety topics and potential signals.

  • Strong documentation practices.

  • Proficiency in Microsoft Office applications.

Scientific Writing Skills

  • Excellent written English.

  • Strong scientific writing capabilities.

  • Ability to prepare clear, concise, and scientifically balanced narratives.

  • Ability to communicate complex safety information effectively.

  • Ability to develop evidence-based conclusions and executive summaries.

  • Strong attention to detail and document quality.

Soft Skills and Behavioral Competencies

  • Strong communication skills.

  • Strong stakeholder engagement capabilities.

  • Ability to work independently with limited supervision.

  • Strong organizational and time-management skills.

  • Ability to manage multiple deliverables simultaneously.

  • Ability to manage competing priorities.

  • Ability to work effectively under regulatory deadlines.

  • Self-motivated and proactive approach.

  • Adaptability to changing timelines and business priorities.

  • Strong attention to detail.

  • Ability to challenge inputs constructively.

  • Strong collaboration and problem-solving skills.

Key Deliverables

The position may be responsible for the preparation, review, coordination, and finalization of:

  • PSURs

  • PBRERs

  • DSURs

  • Medical Device PSURs

  • Canadian Annual Reports

  • US PADERs

  • Other periodic safety reports

  • Ad hoc aggregate safety reports

  • Safety narratives

  • Executive summaries

  • Benefit-risk assessment content

  • Regulatory responses

  • Safety-related supporting documentation

Core Competencies

  • Pharmacovigilance

  • Aggregate safety reporting

  • Drug safety

  • Consumer safety

  • Scientific writing

  • Safety data analysis

  • Benefit-risk assessment

  • Signal evaluation

  • MedDRA

  • Regulatory compliance

  • Literature review

  • Medical and scientific concepts

  • Quality control

  • Inspection readiness

  • Stakeholder management

  • Cross-functional collaboration

  • Project and timeline management

  • Process improvement

Role Expectations

The CS Writing Scientist is expected to independently manage complex aggregate reporting activities while maintaining high standards of scientific accuracy, regulatory compliance, and document quality.

The role requires strong ownership of deliverables, effective stakeholder coordination, the ability to interpret safety data, and the judgment to challenge or escalate issues when appropriate.

The successful candidate should be able to balance multiple regulatory deadlines while maintaining accuracy, consistency, traceability, and inspection readiness.

About Haleon

Haleon is a consumer health company focused on improving everyday health through a combination of scientific expertise and understanding of consumer needs. Its portfolio includes brands such as Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum.

The organization emphasizes innovation, collaboration, inclusion, professional development, and creating meaningful health outcomes for consumers globally.

Equal Opportunities

Haleon is committed to creating an inclusive workplace where diverse backgrounds, perspectives, and experiences are valued and respected. Employment decisions are made fairly and without discrimination.

Adjustments and Accommodations

Candidates requiring reasonable adjustments or accommodations during the recruitment process can contact their recruiter and provide details of the specific support required. Haleon states that such information will be handled confidentially.

Candidate Communication

Candidates should be aware that Haleon’s recruitment team will contact applicants using an official @haleon.com email account. Candidates should verify the source of any recruitment communication if they are uncertain about its authenticity.