- Analyze comprehensive development and post-market product information, synthesize findings, conduct benefit-risk assessments, and generate reports including Risk Management Plans (RMP), Investigator's Brochure Safety Summaries (ISS), and aggregate reports.
- Take primary ownership and accountability for product signaling review, analysis, delivery, and approval.
- Proactively monitor product safety profiles from First-in-Human (FIH) trials throughout the product lifecycle.
- Manage all medical safety aspects of assigned studies and post-market products, serving as the subject matter expert.
- Lead and manage internal medical safety governance bodies, ensuring timely action and communication in safety governance forums.
- Prepare for and support pharmacovigilance audits and inspections, focusing on product-specific medical safety aspects.
- Provide medical safety oversight and key input to various documents including protocols, investigator brochures, safety summaries, clinical study reports, regulatory reports, and labeling.
- Oversee and maintain Pharmacovigilance Agreement (PVA) and Safety Data Exchange Agreement (SDEA) management, as well as Contract Research Organization (CRO) management concerning medical safety processes.
- Ensure all assigned medical safety activities comply with pharmacovigilance standard operating procedures (SOPs) and relevant guidelines.
- Medical degree (human medicine or veterinary medicine).
- Minimum 6 years of experience in medical safety within a global role, preferably with experience in phase 3 and beyond.
- In-depth knowledge of Good Pharmacovigilance Practices (GVP), FDA guidance documents, and global pharmacovigilance legislation.
- Proficiency in safety databases and data visualization.
- Fluent in English.
- Effective communication and negotiation skills, with the ability to thrive in a matrix organization and solve complex problems.
Senior Safety Physician - United Kingdom - Skills Alliance
Description
Position: Senior Safety Physician
Description:
We are seeking a Senior Safety Physician to join our international team dedicated to ensuring the safety of our vaccine products. The team operates globally, with members based in Germany and the USA. Together, they conduct continuous data collection and assessment to manage the benefit-risk profile of our vaccines, whether authorized or still in clinical development.
Your role will involve leveraging your medical expertise and extensive knowledge of pharmacovigilance (PV) legislation to contribute to our team. We are looking for an individual who excels in analytical thinking, can navigate complex data, establish structured processes, and effectively communicate information across our global team.
Responsibilities:
Qualifications: