Parexel FSP has an exciting opportunity for a Director, Risk Management to join our team in Europe. This role can also be based in any European location and will be a fully remote home-based position.
Job Summary:
The Director, Risk Management will provide strategic expertise to product teams and will drive the execution of Risk Management (RM) activities included within RMP (Risk Management Plans) across business units to embed a culture of innovative and efficient risk management strategies to enhance patient safety.
They will provide expertise regarding RMP requirements and implementation for pre-marketed and post-marketed drug products and recommend appropriate risk mitigation options for drug related safety issues, considering the vantaggi-risk profile of the drug, and approaches used for other products both internally and externally.
Key Accountabilities:
- Acts as a SME for Safety SOPs.
- Manages special projects and assists with communications. Provides guidance and coaching to less experienced colleagues; participates in initial training of newly hired team members,
acts as first point of contact to assist others in issue resolution as necessary.
- Has the foresight and judgement to recommend and then manage external safety KOL consultations, expert working groups, and other external safety forums.
- Implements opportunities identified for consistency and standardization in Safety.
- Identifies and evaluates issues and presents strategies to ensure that timelines are met or accelerated.
- Influences above country and local individuals responsible for Safety, Regulatory, and Medical for appropriate risk management development and implementation.
- With oversight, provide strategic guidance for risk management planning, taking into consideration local regulatory requirements, risk management best practices, and product specific risk profile, and development and implementation of RMP initiatives for products within the sponsor portfolio
- Leads using effecti
📌 Director, Risk Management (Roma)
🏢 Parexel
📍 Roma