CS Writing Scientist

Job Summary

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.

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 and 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.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.