Drug Benefit-Risk Evaluation/Pharmacovigilance Medical Writing Manager

Candidates must be EU/UK based Drug Benefit-Risk Evaluation/Pharmacovigilance Medical Writing Manager Summary The Pharmacovigilance Medical Writing Manager is responsible for the development, authoring, editing and quality review of a range of scientific, medical and regulatory documents supporting pharmacovigilance and drug benefit-risk evaluation activities. The role will contribute to documents including, but not limited to, Aggregate Reports, Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), protocols, investigator brochures, clinical study reports, responses to regulatory questions and other clinical and regulatory documents. The Medical Writing Manager will work independently and collaboratively with Pharmacovigilance Project Leads, Drug Safety, Benefit-Risk, Clinical, Regulatory and other relevant functions to ensure that documents are scientifically accurate, clinically meaningful, strategically aligned and compliant with applicable Good Clinical Practice requirements, legislation, company SOPs and global regulatory standards. ResponsibilitiesContributes to the development and implementation of Medical Writing best practices, policies, SOPs and process improvement initiatives, driving greater efficiency and consistency in the authoring, review, editing and finalisation of documents.Develops and refines document templates to improve alignment and efficiency across departments and programmes, in accordance with regulatory guidelines and internal standards.Defines document development strategies and resourcing requirements for programmes, including the engagement and oversight of external medical writing vendors.Leads document execution activities, including defining development strategies, implementing review and revision processes, establishing timelines, assigning resources, facilitating document-related meetings and coordinating cross-functional updates.Defines data and content requirements to ensure the timely completion of key documents for complex global drug development and pharmacovigilance programmes.Authors, edits and quality-reviews scientific, medical and regulatory documents, including Aggregate Reports, RMPs, REMS, protocols, investigator brochures, clinical study reports, regulatory responses and benefit-risk evaluation materials.Supports the preparation and communication of drug benefit-risk evaluations and assessments, integrating safety, efficacy, clinical and regulatory information into clear and scientifically robust documentation.Collaborates with clients, pharmacovigilance professionals, safety scientists and cross-functional stakeholders to ensure documents meet required standards for content, accuracy, format and style.Interprets complex clinical and safety data and translates scientific information into clear, consistent and strategically appropriate messaging for regulatory and scientific audiences.Maintains up-to-date knowledge of relevant therapeutic areas, scientific developments, product labelling, pivotal studies and disease-state management.Integrates scientific and clinical expertise with global regulatory, pharmacovigilance and compliance requirements to support materials submitted as part of the product approval and lifecycle management process.Uses appropriate software, databases, platforms and tools to organise, analyse and maintain document references and supporting information.Attends and participates in relevant client and internal meetings, providing medical writing and benefit-risk expertise as required.Supports the continued development of Medical Writing and Pharmacovigilance capabilities through training, mentoring and knowledge sharing.Keeps senior leadership informed of project status and escalates issues that may affect document quality, timelines, resources or project budgets.Provides new business cost estimates when required and supports business development activities relating to pharmacovigilance, drug safety, benefit-risk evaluation and medical writing services. Requirements8–10 years of relevant experience, including medical writing experience within the pharmaceutical, biotechnology or life sciences industry.Strong experience in pharmacovigilance, drug safety, benefit-risk evaluation and regulatory medical writing (non negotiables). Excellent working knowledge of relevant terminology, ICH guidelines, GCP, SOPs, global pharmacovigilance requirements and quality management processes.Superior scientific writing, editing and communication skills, with strong data analysis capabilities and the ability to interpret complex clinical and safety information.Demonstrated ability to develop clear, consistent and strategically appropriate scientific and regulatory messaging for diverse audiences.Experience coordinating and overseeing the work of multiple pharmacovigilance, medical writing and/or vendor resources across multidisciplinary teams.Direct pharmaceutical/biotechnology industry experience, with an understanding of clinical trials, drug development, regulatory submissions, pharmacovigilance reporting and medical communications.Working knowledge of global legal, regulatory and compliance requirements relating to pharmacovigilance and drug safety.Experience with benefit-risk assessment/evaluation and the integration of safety and efficacy information into regulatory and scientific documentation.Proficiency with Embase, OvidPV, PubMed and Microsoft Office Suite, including Outlook, Word and Excel.Experience with safety databases such as Oracle Argus Safety, ArisGlobal LifeSphere, Veeva Safety and AB Cube SafetyEasy is highly desirable. To Applygjohnstone@barringtonjames.com+441293778666