GLOBAL SENIOR SAFETY PHYSICIAN
The global team consists of subject matter experts for vaccine safety who work either from our site or remotely in the USA. Together they constantly collect and assess data for the life cycle benefit risk management across our vaccines whether authorized or still in clinical development.
You would add your medical expertise as well as your in-depth knowledge of PV legislation to the team. We are looking for an analytical thinker who can handle complex data, build up structured processes and communicate information across a global team alike.
Your Responsibilities
The global team consists of subject matter experts for vaccine safety who work either from our site or remotely in the USA. Together they constantly collect and assess data for the life cycle benefit risk management across our vaccines whether authorized or still in clinical development.
You would add your medical expertise as well as your in-depth knowledge of PV legislation to the team. We are looking for an analytical thinker who can handle complex data, build up structured processes and communicate information across a global team alike.
Your Responsibilities
- Analysis of comprehensive development and post-market product information, synthesis, benefit-risk assessment, and reporting, incl. RMP, ISS, and aggregate report generation
- Primary ownership and accountability for product signaling review, analysis, delivery, and approval
- Proactive monitoring of product safety profiles from FIH throughout the lifecycle.
- Manages all medical safety aspects of allocated studies and post-market products and serves as the subject matter expert from a medical safety perspective.
- Leadership and ownership of internal medical safety governance bodies including timely action and communication as per safety governance forums.
- PV audit and inspection preparation and support for product-specific medical safety aspects
- Provide medical safety oversight and key input to protocols, investigator brochures, safety summaries, clinical study reports, regulatory reports (periodic, ad hoc), and labeling.
- Oversee and maintain PVA/SDEA management as well as CRO management concerning medical safety processes.
- Ensure that all assigned medical safety activities are set up in line with the PV standard operating procedures (SOPs) and relevant guidelines.
- Medical degree - human medicine or veterinary medicine
- Minimum 6 years of work experience in medical safety in a global position with marketed and development products (preferably phase 3 and beyond experience)
- In-depth knowledge of GVP, FDA guidance documents, and in general global PV legislation
- Safety database knowledge and data visualization skills
- Fluent in English
- Effective communication and negotiation skills, comfortable with working in a matrix organization, and able to break down problems to find solutions.
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Seniority level
Mid-Senior level -
Employment type
Full-time -
Job function
Research -
Industries
Biotechnology Research and Pharmaceutical Manufacturing
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