Hybrid Clinical Safety and Risk Management Associate Principal Scientist

at MSD

• Job title: Clinical Safety and Risk Management Associate Principal Scientist
• Job type: Full Time
• Experience level: Junior, Mid level
• Salary: Not specified
• Degree requirement: Professional Certificate
• Location requirements: Hybrid, Prague, Czech

About the role

• Clinical Safety and Risk Management Associate Principal Scientist performing medical review of safety reports at a global healthcare leader. Collaborating with physicians and regulatory agencies to ensure product safety.

Responsibilities

• Performs primary medical review of serious adverse experience (AE) reports and other AE reports of interest in order to monitor and describe the safety profile of assigned products
• Takes an active role in oversight and development of pharmacovigilance and risk management plans (RMPs)
• Assists the CSRM physician to prepare responses to inquiries from health professionals and regulatory agencies regarding adverse experiences
• Collaborates with the CSRM physician, strategizing with the RMST, recommending appropriate data to respond to queries and analyze data
• Applies clinical, pharmacological, and epidemiologic knowledge and information technology (IT) skills in order to manage safety surveillance and risk management of assigned products
• Accountable for monitoring the safety profile of assigned products
• Prepares responses to safety inquiries from various stakeholders
• Participates in the development, implementation and evaluation of standards, processes, metrics, and other department initiatives

Requirements

• At least two years of clinical experience in a patient care setting is required
• Minimum 5 years of professional experience with both clinical and pharmaceutical industry experience required
• A minimum of 2 years MUST include safety experience (e.g. PV or clinical) involving causality assessment, analysis of aggregate safety data and/or authoring of safety documents
• Experience in drug safety, pharmacovigilance and/or risk management
• Excellent writing and communication skills in English
• Demonstrated leadership skills in managing programs, processes, and facilitating meetings
• Effective presentation skills and experience influencing and negotiating
• Computer skills - use of database and basic MS Office suite applications
• Problem solving, conflict resolution and critical thinking skills

Benefits

• Flexible Work Arrangements: Hybrid
• Professional Development Opportunities