Job Description

The Medical Safety Review Physician will work closely and collaboratively with colleagues in other departments in the Company, including but not limited to Clinical Safety Scientists, Clinical Directors in Clinical Research, CSRM Physicians, and CSRM Associates and Scientists, Global and US Pharmacovigilance and Global Pharmacovigilance Case Management. The MSR Physician will be an extended member of the Risk Management Safety Teams (RMST’s) for the products that they support, and other relevant sub-teams.

The Medical Safety Review Physician is under the direction and oversight of the Associate Vice-President, Head of ICMR, ICMR Senior Director, ICMR Directors/Therapeutic Area Team Leads (TAL).

Key responsibilities:

• As required per SOP, provide in-line medical review of individual case safety reports (ICSRs) arising from our Company’s clinical trials and other sources, as required, and will include to determine or confirm the need for expedited reporting to regulatory agencies, ensure the quality coherence, and accuracy of the case narrative, performs a medical assessment of the case in the context of the available safety data and the known safety profile, and provide a company statement and a causality assessment which will be included as part of the Individual Case Report

• Improve the accuracy and completeness of the case report by generating medical queries, as needed, which will be communicated to the corresponding site via the safety database

• Ensure compliance with global expedited reporting timelines with timely case assessment

• Under the direction of the MSR Director (TAL) and/or the Senior Director, perform Analysis of Similar Events (AOSE) when applicable

• May participate in quality review of ICSRs from other MR Physicians and Associates

• May lead and/or participate in cross-functional projects as the MSR subject matter expert contributing to continuous process improvement of ICSR assessments

• Consult with the Clinical Director for the trial and with the Clinical Safety and Risk Management (CSRM) Physician, as needed, for cases requiring additional clinical or safety subject matter expertise

• May participate in the training of the specified MSR Team

• May participate in process, quality, innovation, technology and other business-related activities

• May participate on special projects or rotational assignments within or outside of ICMR as part of their professional development

Qualifications, Skills and Experience

• Minimum of 1 year experience in clinical medicine following training, with 3 years of experience preferred; this experience is required in patient care settings

• A minimum of 3 years of relevant work experience that may include both clinical medicine practice post training and pharmaceutical industry experience required

• The candidate must have a strong understanding of scientific and medical concepts

• Excellent writing and communication skills in English required

• Effective presentation skills and experience influencing and negotiating required

• Computer skill required- use of database and basic MS Office suite applications

• Problem-solving, conflict resolution, and critical thinking skills are required.

Preferred Experience and Skills:

• Medical specialization

• Experience in drug safety, pharmacovigilance and/or risk management is highly desirable

• Prior medical review and/or case management experience

• Relevant Safety Systems Experience (i.e., Argus, ARIS-G, etc.)

• Drug development experience (early or late phase clinical research, regulatory affairs, and/or safety/PV)

• Demonstrated leadership skills in managing programs & processes, leading meetings, and influencing peers and direct reports to drive results

• Experience working and collaborating with global teams

Education:

• M.D. or equivalent Ex US degree in Medicine

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