Brief Description:

The Manager, Medical Safety Operations, will be responsible for coordinating and managing the operational aspects and supporting the strategies of Medical Safety including the Organ Safety Advisory Panel (OSAP), Coffee Connection and other medical safety initiatives. This role will combine knowledge of PV with strong project management, operational and interpersonal skills to ensure smooth execution of the strategies of Medical Safety and oversight, documentation and execution of OSAP / Medical Safety Governance activities. The role will also support key operations related to Medical Safety such as process development/improvement (SOP/WI), audit/inspection-related activities, contracts, procurement, healthcare professional (HCP) engagement, and cross-functional collaboration to meet strategic objectives for Medical Safety / GRADS organization.

Essential Functions/Responsibilities

• Working closely with the Medical Safety Leadership Team, the Manager, Medical Safety Operations, is expected to:
  • Manage and coordinate Operations of Medical Safety-related activities
  • Provide strategic support of Medical Safety-initiatives
  • Develop and maintain OSAP charters, governance documents, and procedural guidelines.
  • Lead planning and execution of OSAP meetings, including agenda development, scheduling, pre-read preparation, logistics, meeting facilitation, interacting with presenting project teams, taking and archiving meeting minutes.
  • Track and document OSAP action items, and follow-up activities to ensure timely completion/escalation
  • Serve as the primary point of contact for OSAP operations, ensuring effective and timely communication across Medical Safety, Clinical Development, and other relevant stakeholders, such as internal and external experts.
  • Serve as primary point of contact for procurement system (e.g., Coupa) transactions and approvals related to medical safety activities.
• Coordinate HCP engagement logistics (e.g. contracting, non-compete agreement, FMV) in compliance with company standards.
• Manage project team spaces (e.g., SharePoint, MS Teams) for effective communication and collaboration.
• Identify process gaps related to Medical Safety and drive process (SOP/WI) development, improvement and training to ensure full compliance with world-wide regulations
• Assess regulatory intelligence impacting Medical Safety and collaborate with key stakeholders (e.g., QPPV, GRADS Compliance) to update or develop procedures ensuring regulatory compliance and operational excellence.
• Collaborate with GRADS Alliance Management, Legal, Finance, and Procurement to ensure timely and compliant contract processing.
• Support additional medical safety initiatives requiring project management, coordination, and documentation.
• Participate in cross-business partnership projects described in the SDEA, internal audits and Health Authority inspections, as required.

Required Knowledge, Skills, and Abilities

• Minimum of 3 years of experience in PV / safety operations, pharmaceutical project management (PMP certification or equivalent project management training preferred).
• A minimum facility with comprehension and analysis of PV-related scientific information including being able to rapidly assimilate scientific terminology and understand the logical inferences about cause and effect.
• Experience managing contracts and governance documentation, with a strong understanding of project management principles and tools.
• Excellent organizational, prioritization, communication, and facilitation skills.
• Skilled in managing multiple priorities.
• Ability to work independently with minimal supervision while fostering team collaboration.
• Proficiency in Microsoft Office Suite, with the ability to quickly learn new software and database systems.

Required/Preferred Education and Licenses

• A minimum of Bachelor’s degree (preferably a Master’s degree) in life sciences, public health, or related scientific/technical field, such as RN, PharmD, MPH, or Pharmaceutical Sciences.

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