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 integral programmes
- Authors, edits and quality-reviews a range of scientific and

📌 Pharmacovigilance Manager (España)
🏢 Barrington James
📍 España