Job Description

Job title: CSRM Physician

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

Key responsibilities:

• Engage directly in product development activities via core membership on Product Development Teams and chairmanship of the Risk Management and Safety Team (RMST), and other related sub-team participation, for assigned products. This may include participation in internal and joint internal/external research project teams relevant to ongoing clinical development (pediatric fillings, new markets) and the further study of marketed compounds.
• Partners with clinical development to ensure that clinical programs will support robust safety assessment of products ongoing clinical development. Works with Clinical Research to develop the benefit-risk evaluation in aggregate safety reports.
• 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 signaling 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 labeling, 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 labeling 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 summaries in support of regulatory filings 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.
• Manages a team of safety physicians and has an oversight role for their products.
• Serves as the Physician Management Reviewer for post approval safety signaling reviews.

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
• 6 years of relevant 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 analysis of aggregate safety data, authoring of safety documents, signal detection and risk management.
• 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:

Accountability, Accountability, Clinical Development, Clinical Judgment, Clinical Research, Clinical Risk Management, Clinical Safety, Clinical Trial Oversight, Clinical Trials, Communication, Cross-Functional Teamwork, Data Analysis, Detail-Oriented, Drug Safety Surveillance, Epidemiology, Intellectual Curiosity, Interpersonal Relationships, Machine Learning, Pharmacovigilance, Post Marketing Surveillance, Product Labels, Product Risk Management, Risk Management, Safety Databases, Safety Reporting {+ 1 more}

Preferred Skills:

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Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

10/30/2025

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