Clinical Safety Consultant with scientific background (m/w/d)
Ort
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Rahmendaten
<p><strong>Clinical Safety Consultant (m/f/d)<br> <br> Project Overview:</strong><br> <br> Consultant works closely with clinical safety physicians and assists aggregate report generation, signal identification and evaluation, in the specialty medicines therapeutic area for several marketed products in Europe. Consultant works with global safety staff (in US/Japan), other DS functions (Medical Affairs, Regulatory Affairs) and contracted vendors.<br> <br> <strong>Project Details:<br> <br> Start Date: </strong>01. June 2025<br> <strong>End Date:</strong> May 2026<br> <strong>Workload:</strong> full-time<br> <strong>Travel Requirements:</strong> Not planned<br> <strong>Duration:</strong> Long-term, with possibility of extension<br> <br> <strong>Location:</strong> 100% remote<br> <br> <strong>Key Responsibilities:</strong></p> <ul> <li> <p>Support clinical safety physicians in the preparation of aggregate safety reports (PSURs/DSURs) for authorized products in the specialty medicines portfolio.</p> <li> <p>Lead the project management of report preparation, including timeline planning, process oversight, and document handling within global systems.</p> <li> <p>Provide expert input on risk management activities, including signal detection, evaluation, mitigation, and updates of core safety documents (e.g., EU-RMP, signal assessment reports).</p> <li> <p>Develop and implement safety communication strategies for both internal and external stakeholders (e.g., EU risk minimization activities) in close collaboration with product safety physicians and local safety officers.</p> <li> <p>Act as first author of safety-related communications and oversee their execution across EU affiliates.</p> <li> <p>Independently document team meetings, decisions, and action points, and ensure proper archiving of documentation and ongoing tracking of safety signals in relevant systems.</p> <li> <p>Serve as project manager for safety-related topics involving signal management and aggregate reporting, ensuring adherence to timelines and regulatory standards.</p> </ul> <h4><strong>Qualifications:</strong></h4> <ul> <li> <p>University degree in a scientific discipline required (Bachelor’s minimum, Master’s or PhD preferred)</p> <li> <p>At least 5 years of relevant experience in pharmacovigilance or medical safety</p> <li> <p>Proven project management experience (5+ years with advanced degree; 7+ years with Bachelor’s)</p> <li> <p>Fluent in business English (written and spoken); German language skills desirable</p> <li> <p>Strong communication and interpersonal skills</p> <li> <p>Experienced in cross-functional collaboration within global matrix organizations</p> </ul>
