A Technical Writer writes product instructions, user manuals or other material that helps to explain complex information or procedures. Writes help information available to customers online, or clear explanations of company policies. Supports internal communication among different technical, engineering and scientific specialists working on a project or product. Creates product documentation, and provides input for improving product design.
We are partnering with a global life sciences organization seeking a Drug Safety Consultant to support aggregate safety reporting across a broad portfolio of pharmacovigilance activities. Our team is looking for a strong scientific writer who can author, review, and manage high-quality aggregate reports while collaborating with global stakeholders and vendors.
Responsibilities:
Author, review, and support aggregate safety reports, including PSURs, PBRERs, DSURs, PADERs, and other local or developmental/post-marketing reports. Manage report timelines, coordinate stakeholder input, and help maintain the annual global aggregate reporting schedule. Interpret medical and scientific data from large datasets and convert findings into clear, concise narrative content and regulatory documentation. Collaborate with internal teams, external vendors, and document management partners to support report quality, template maintenance, and process improvements.
Required:
Strong hands-on authoring experience is required; candidates with only QC, compilation, input, or review support without significant writing ownership will not be a fit. Direct experience authoring aggregate safety reports is strongly preferred, including PSUR/PBRER, DSUR, or other developmental/post-marketing safety reports. Experience with scientific or regulatory writing in a pharmaceutical, PV, or related safety environment is required; clinical study report authoring, signal report writing, or similar medical writing experience may also be considered if it demonstrates substantial authoring ownership. Minimum of 5 years of pharmacovigilance experience is preferred, with around 4 years considered only for exceptionally strong candidates; strong Microsoft Excel and Word skills are required, including pivot tables and advanced document editing/formatting.
About SSI People:
With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from SSi People and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: SSi People Privacy Policy
