Research Scientist at Valence Labs developing ML models for predicting cellular responses in drug discovery. Building generative models based on massive multiomics datasets with collaborative research.
MS
Hybrid Clinical Safety and Risk Management Associate Principal Scientist
Posted 2 months ago
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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