Associate Principal Scientist, Medical Safety Review Physician

Job Description
Under the direction and oversight of the Associate Vice-President, Head of ICMR, ICMR Senior Director, ICMR Directors/Therapeutic Area Team Leads (TAL), the Medical Safety Review (MSR) Physician will

• As required per SOP, provide in-line medical review of individual case safety reports (ICSRs) arising from our 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.
• 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

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 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.

Required Skills
Adaptability, Adaptability, Audit Process Evaluations, Case Report Forms, Clinical Judgment, Clinical Medicine, Clinical Research, Clinical Risk Management, Clinical Sciences, Communication, Compliance Program Development, Continual Improvement Process, Critical Thinking, Data Analysis, Decision Making, Detail-Oriented, Drug Safety Surveillance, Ethical Compliance, Healthcare Risk Management, Medical Writing, Pharmacokinetics, Pharmacovigilance, Post Marketing Surveillance, Regulatory Communications, Regulatory Compliance Audits {+ 3 more}

Preferred Skills
Current Employees apply HERE

Current Contingent Workers apply HERE

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status
Regular

Relocation
VISA Sponsorship
Travel Requirements
Flexible Work Arrangements
Hybrid

Shift
Valid Driving License
Hazardous Material(s)
Job Posting End Date
11/14/2025

• A job posting is effective until PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID
R359088