
Aggregate Safety Reports Medical Content Specialist
9 hours ago
We are seeking a highly skilled Medical Writer to author aggregate safety reports and join our Safety team.
Responsibilities:- Accountable for the entire life cycle of documents, ensuring quality, timeliness, and compliance with internal/client SOPs and regulations.
- Responsible for end-to-end authoring of complex deliverables – periodic aggregate reports, including PBRERs, DSURs, SUSARs, PADERs/PAERs, ACOs, RMPs, and ad-hoc regulatory and safety reports.
- Perform review to validate accuracy and relevance of data presented in documents against source data or references used.
- Support junior writers with incorporation of review comments, tracking, and communication.
- Medical/M. Pharm/Pharm D/Life sciences degree.
- Minimum 2 years' experience in medical writing or equivalent experience in life sciences domain with experience in End-to-End authoring of periodic aggregate reports.
- Proficient in document management systems and other relevant applications (e.g. Excel, Outlook).
Why this role is crucial: Our Medical Writer will play a key part in ensuring the quality and accuracy of our safety reports, directly impacting public health and safety.
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