Associate Principal Scientist, Medical Safety Review Physician
Associate Principal Scientist, Medical Safety Review Physician
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1 Vacancy
Job Description
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 (RMSTs) 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 Companys 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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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:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Preferred Skills:
Job Posting End Date:
09/16/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Staff IC
Employment Type
Full-Time
