Clinical Safety and Risk Management Principal Scientist

Job Description

The CSRM Physician is a leader in pharmacovigilance and is responsible for the overall clinical risk management and safety surveillance of assigned marketed products. As chairs of the Risk Management Safety Team (RMST), CSRM physicians lead the development and maintenance of risk management and pharmacovigilance plans.

Primary activities include, but are not limited to:

• Chair of the Risk Management and Safety Team (RMST) a subteam of the PDT, for assigned products. This may include participation in internal and joint internal/external research project teams relevant to the further study of marketed compounds.
• The CSRM Physician works closely with cross-functional team members including those from clinical development, epidemiology, regulatory affairs, statistics, and manufacturing to manage safety topics under evaluation to ensure efforts are aligned to meet global pharmacovigilance and risk management strategies for assigned products.
• Duties include all aspects of safety data evaluation, including assessing safety from multiple sources, e.g., clinical trials, literature and post-approval use and ensuring completeness of safety information in company core data sheets (CCDS).
• Accountable for scientific strategy for safety related documents (e.g., CTD components, Risk Management Plans (RMP) and Periodic Safety Update Reports) and for ensuring that the safety sections of Company product circulars are medically and scientifically appropriate.
• Responsible for safety surveillance activities for assigned products such as aggregate data analysis and post approval safety signalling reviews, using medical judgment in review of aggregate data and individual cases. Collaborates with CSRM Associate in order to oversee all safety surveillance activities for assigned products.
• Responsible for risk management activities such as contributing to recommendations for pharmacovigilance actions, making recommendations for labelling, and developing the RMPs, pharmacovigilance strategies and risk minimization activities as warranted in collaboration with CSRM medical associate.
• Oversees the review and approval of product labelling files stored in the safety database and demonstrates a working knowledge of MedDRA
• The CSRM Physician prepares safety summaries and analyses of safety related data for regulatory documents, aggregate reports, and may supervise the activities of CSRM medical associates in the execution of safety data analysis and authoring of regulatory documents.
• Participates in the development, implementation and evaluation of standards, processes, metrics, and other department initiatives.

Education:

• Required: Medical Doctor (MD)
• Preferred: Medical specialty

Required Experience and Skills:

• Minimum of 2-3 years clinical experience (in a patient care setting) following post-graduate medical training or other relevant clinical experience
• Minimum 7 years of professional experience with both clinical and pharmaceutical industry experience required, of which a minimum of 4 years MUST include safety experience (e.g. PV or clinical) involving causality assessment, analysis of aggregate safety data and/or authoring of safety documents
• Demonstrated organizational leadership skills
• Excellent communication, and writing skills in English
• Demonstrated skills in managing programs, processes, and facilitating meetings
• Effective presentation skills and experience influencing and negotiating
• Problem solving, conflict resolution and critical thinking skills

Required Skills:

Preferred Skills:

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