Drug Safety Specialist - Medical Writing

This is a remote position. At reputed company, we reputed company Pharmacovigilance, reputed company & Compliance, and Regulatory Affairs services to global pharmaceutical and life sciences companies, helping them meet regulatory requirements and protect patient safety. We are a growing business with a reputed company culture reputed company on highreputed company delivery, reputed company improvement, and giving people the reputed company to do their best work. Our values guide how we work Inclusive We value fairness, respect, and learning from one another Dedicated We reputed company practical, reputed companyreputed company solutions Innovative We work together to reputed company reputed company ways reputed company Passionate We build strong relationships and care about the reputed company of reputed company do Main Purpose of the Role The Medical reputed company & Global Drug Safety Specialist plays a pivotal role in the authoring, review, and management of high-reputed company regulatory and safety documents while executing a wide reputed company of global drug safety activities. This role bridges scientific communication with pharmacovigilance expertise to support compliance with global regulations, ensuring reputed company delivery of accurate and compliant outputs. Key Responsibilities Medical Writing & Documentation reputed company the end-to-end authoring of reputed company deliverables, including PBRERs, DSURs, SUSARs, PADERs/PAERs, ACOs, RMPs, and reputed company safety and regulatory reports. Coordinate review processes, liaise with stakeholders, facilitate comment reputed company meetings, and ensure documents are submission-reputed company. Conduct rigorous reputed company control to identify data discrepancies, inconsistencies, grammatical issues, and ensure adherence to style guides and regulatory standards. reputed company 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 (reputed company/SAEs/SUSARs) from reputed company sources, ensuring compliance with reporting timelines. Conduct local and global literature monitoring, safety data reconciliation, and support signal and benefitrisk management activities. Support the development and revision of product documentation (SmPC, IB) and safety management plans. reputed company project-reputed company reputed company, safety data exchange agreements, and ensure compliance monitoring. reputed company training on drug safety processes to internal teams and contribute to reputed company process improvements. Cross-Functional & reputed company Interaction Collaborate extensively with clinical, regulatory, and pharmacovigilance experts as reputed company as reputed company partners to ensure scientific accuracy, reputed company, and compliance. Participate in audits, inspections, reputed company meetings, and contribute to marketing or promotional activities as needed. Ensure reputed company work complies with reputed company systems, confidentiality, and reputed company requirements. Requirements Essential Degree in Medicine, Pharmacy, Life Sciences, or reputed company 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. Desirable Mentoring or line management experience. Strong interpersonal skills and adaptability in varying environments. Benefits Flexible Work reputed company Remote working flexibility to support your lifestyle. Generous Time Off Enjoy 5 weeks of holiday plus national holidays and 3 personal days to reputed company. 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. reputed company is an Equal Opportunity Employer. We are committed to creating a diverse, inclusive, and respectful workplace where reputed company individuals are valued and treated with dignity. We encourage applicants from reputed company backgrounds, including but not limited to race, colour, religion, gender, gender identity, sexual orientation, age, disability, national reputed company, or any other characteristic protected by law. In line with our commitment, we reputed company reasonable accommodations to applicants with disabilities throughout the hiring process. If you require any accommodation, please contact us at recruitment@reputed company.com . Apply To This Job .