Patient Safety Partner

The Patient Safety Partner (Lead) is responsible for the implementation, maintenance, and oversight of the local pharmacovigilance (PV) system for assigned affiliates. This role sets the strategic direction for patient safety and risk management, ensuring alignment with global priorities and local business needs.

Key Responsibilities

• Lead and facilitate safety strategy and planning to prioritize impact.
• Collaborate with affiliate leadership and global teams to leverage safety insights and influence organizational strategies.
• Act as the primary point of contact for safety-related matters, including interactions with local regulatory authorities.
• Design and maintain effective local PV processes, ensuring compliance and continuous improvement.
• Oversee safety-related activities, including individual case safety reports, signal detection, risk management, and safety labeling.
• Shape the local PV ecosystem by promoting regulatory reliance and international harmonization.
• Drive safety solutions for launch readiness and integrate safety insights into the patient journey.
• Foster cross-functional partnerships to address complex compliance challenges and product-related gaps.

Requirements

• Degree in a life science or healthcare-related discipline.
• 3-5 years of experience in clinical research or development, with at least 3 years specifically in PV or safety at an affiliate or regional level.
• Proven experience in global and local matrix environments, including stakeholder management and influencing.
• Expertise in relevant PV and medical device regulations and experience interacting with health authorities.
• Strong strategic leadership, negotiation, and analytical skills.
• Customer-centric mindset with an understanding of health systems and patient journeys.
• Ability to adapt to dynamic environments and leverage new technologies like AI and automation in PV processes.