Associate Principal Scientist, Medical Safety Review Physician Full-time

Individual Case Medical Review (ICMR) Physician

Under the direction and oversight of the ICMR Directors/Therapeutic Area Team Leads (TAL), the ICMR Physician will:

1. As required per SOP, provide in-line medical review of individual case safety reports (ICSRs) arising from Merck Sharp & Dohme LLC (Company) clinical trials and other sources, as required, and will include the following actions:
• 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
2. 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
3. Ensure compliance with global expedited reporting timelines with timely case assessment
4. Under the direction of the ICMR Director (TAL), perform Analysis of Similar Events (AOSE) when applicable
5. May participate in quality review of ICSRs from other ICMR Physicians and Associates
6. May lead and/or participate in cross-functional projects as the ICMR subject matter expert contributing to continuous process improvement of ICSR assessments
7. 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
8. May participate in the training of the specified ICMR Team
9. May participate in process, quality, innovation, technology and other business-related activities
10. May participate on special projects or rotational assignments within or outside of ICMR as part of their professional development

The MSR 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 ICMR 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.

Education Requirement:

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

Required Skills:

• 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

Required Skills:

Adaptability, ARIS Platform, Audit Process Evaluations, Case Writing, Clinical Judgment, Clinical Medicine, Clinical Research, Compliance Program Development, Conflict Resolution, Continuous Process Improvement, Critical Thinking, Data Analysis, Decision Making, Detail-Oriented, Drug Development, Drug Safety Surveillance, Ethical Compliance, Global Team Collaboration, Medical Writing, Pharmacovigilance, Post Marketing Surveillance, Regulatory Affairs Compliance, Regulatory Communications, Regulatory Compliance Audits, Risk Management

Preferred Skills: