Chargé de recherche - Post - doctorant developing a bio - inspired decision support tool for zero carbon energy mix at UniLaSalle in Amiens.
MS
Hybrid Clinical Safety and Risk Management Associate Principal Scientist
Posted last month
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
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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