Drug Safety Specialist - Medical Writing

This is a remote position.

We are a growing business with a collaborative culture focused on high‑quality delivery, continuous improvement, and giving people the space to do their best work.

Our values guide how we work:

• Inclusive – We value fairness, respect, and learning from one another
• Dedicated – We deliver practical, client‑focused solutions
• Innovative – We work together to find better ways forward
• Passionate – We build strong relationships and care about the quality of what we do

The Medical Writer & Global Drug Safety Specialist plays a pivotal role in the authoring, review, and management of high-quality regulatory and safety documents while executing a wide range of global drug safety activities. This role bridges scientific communication with pharmacovigilance expertise to support compliance with global regulations, ensuring timely delivery of accurate and compliant outputs.

Key Responsibilities

Medical Writing & Documentation

• Lead the end-to-end authoring of complex deliverables, including PBRERs, DSURs, SUSARs, PADERs/PAERs, ACOs, RMPs, and ad-hoc safety and regulatory reports.

• Coordinate review processes, liaise with stakeholders, facilitate comment resolution meetings, and ensure documents are submission-ready.

• Conduct rigorous quality control to identify data discrepancies, inconsistencies, grammatical issues, and ensure adherence to style guides and regulatory standards.

• Provide mentoring and guidance to junior writers on structure, style, and compliance.

• Maintain up-to-date knowledge of global regulatory requirements (FDA, ICH, GCP) and ensure adherence to electronic publishing standards.

Global Drug Safety

• Manage the processing of safety reports (AEs/SAEs/SUSARs) from all sources, ensuring compliance with reporting timelines.

• Conduct local and global literature monitoring, safety data reconciliation, and support signal and benefit–risk management activities.

• Support the development and revision of product documentation (SmPC, IB) and safety management plans.

• Oversee project-related contracts, safety data exchange agreements, and ensure compliance monitoring.

• Provide training on drug safety processes to internal teams and contribute to continuous process improvements.

Cross-Functional & Client Interaction

• Collaborate extensively with clinical, regulatory, and pharmacovigilance experts as well as external partners to ensure scientific accuracy, clarity, and compliance.

• Participate in audits, inspections, client meetings, and contribute to marketing or promotional activities as needed.

• Ensure all work complies with quality systems, confidentiality, and security requirements.

Requirements

• Degree in Medicine, Pharmacy, Life Sciences, or related field (advanced degree preferred).
• Minimum 3 years’ experience in medical writing and/or drug safety roles.
• Robust knowledge of regulatory documentation, drug development processes, and global safety regulations (ICH, GVP, GCP).
• Proficiency with safety databases and document management systems.
• Excellent written and verbal communication skills with exceptional attention to detail.
• Strong organisational skills with the ability to prioritise and meet tight deadlines.

• Mentoring or line management experience.
• Strong interpersonal skills and adaptability in varying environments.

Benefits

• Flexible Work Options: Remote working flexibility to support your lifestyle.
• Generous Time Off: Enjoy 5 weeks of holiday plus national holidays and 3 personal days to recharge.
• Home Office Support : Get support to create a productive home office setup.
• Bonuses: Benefit from an annual bonus program, spot bonuses, and employee-nominated recognition.

In line with our commitment, we provide reasonable accommodations to applicants with disabilities throughout the hiring process. If you require any accommodation, please contact us at [email protected] .