Pharmacovigilance Medical Writing Manager

Candidate must be EU-based; this is a remote position

Candidate must have previous vendor (in-house) experience - e.g. CRO/Consultancy

Summary

The Pharmacovigilance Medical Writing Manager is responsible for writing and editing a range of scientific and medical content, 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, in accordance with applicable Good Clinical Practice requirements and legislation. The medical writer will work independently to review client documents and author reports, collaborating with Pharmacovigilance Project Leads and other relevant functions to ensure the accuracy and clarity of all content.

Responsibilities

- Proactively contributes to the development and implementation of Medical Writing best practice, policies, SOPs and process improvement initiatives, leading to more efficient and improved standards and systems for authoring, reviewing, editing and finalising documents, in compliance with applicable company SOPs and regulations
- Develops and refines templates to improve alignment and efficiency across departments and programmes, in accordance with standards and regulatory guidelines and requirements
- Defines document development strategy and resourcing needs for programmes, including medical writing vendor engagement and oversight
- Drives document execution tactics, such as defining document development, implementing review and revision processes, developing timelines (including those relating to document "birth dates"), assigning resources, facilitating document-related meetings,



providing cross-functional updates and defining data needs, to ensure timely completion of key documents for complex global programmes
- Authors, edits and quality-reviews a range of scientific and medical documents, including but not limited to Aggregate Reports, RMPs, REMS, protocols, investigator brochures, clinical study reports, responses to regulatory questions and other clinical and regulatory documents, in accordance with applicable SOPs, Good Clinical Practice requirements and legislation
- Collaborates with clients and pharmacovigilance staff to ensure all documents meet the required standards for content, format and style
- Maintains up-to-date knowledge of relevant therapeutic areas and scientific developments
- Develops and maintains ongoing scientific expertise relevant to therapeutic areas, product labelling, pivotal studies and disease state management
- Integrates scientific expertise with regulatory and compliance guidelines to ensure comprehensive review and creation of materials submitted as part of the approval process
- Uses appropriate software, platforms and tools to organise and maintain document references
- Attends and participates in all relevant client and internal meetings
- Supports the continuous development of Medical Writing capabilities, providing ongoing training and mentoring to Pharmacovigilance team members as needed




- Keeps senior leadership informed, when required, of project status and, in particular, any issues affecting document quality or project budget
- Provides new business cost estimates when required, and supports business development colleagues with new business acquisition for pharmacovigilance projects, including medical writing services

Requirements

- 8-10 years of relevant experience, including education and medical writing experience within the pharmaceutical/biotech industry
- Excellent working knowledge of relevant terminology, International Conference on Harmonisation (ICH) guidelines, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), applicable regulatory requirements and quality management processes
- Superior writing and editorial skills, with strong data analysis capabilities and the ability to interpret clinical data, understand complex scientific and clinical information, and create consistent, strategic messaging for diverse audiences
- Ability to contribute to, oversee and coordinate the work of multiple pharmacovigilance staff members and vendor resources across multidisciplinary teams
- Direct experience in the pharmaceutical/biotech industry, with an understanding of requirements for clinical trials and drug development, regulatory submissions, pharmacovigilance reporting and medical communications
- Understanding and working knowledge of general legal, regulatory and compliance requirements relating to pharmacovigilance
- Proficiency with Embase, OvidPV, PubMed, Microsoft Office Suite (Outlook, Word, Excel), and safety databases such as Oracle Argus Safety, ArisG LifeSphere, Veeva Safety and AB Cube SafetyEasy

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📌 Pharmacovigilance Manager (España)
🏢 Barrington James
📍 España