Associate Principal Scientist, Medical Safety Review Physician — MSD | Joboostr

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Associate Principal Scientist, Medical Safety Review Physician — MSD | Joboostr

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Associate Principal Scientist, Medical Safety Review Physician

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Česko, PrahaDnes

Mám zájem Přizpůsobit životopis

O pozici

Job Description Under the direction and oversight of the ICMR Directors/Therapeutic Area Team Leads (TAL), the Individual Case Medical Review (ICMR) Physician will:

Co budeš dělat

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
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 ICMR Director (TAL), perform Analysis of Similar Events (AOSE) when applicable
May participate in quality review of ICSRs from other ICMR Physicians and Associates
May lead and/or participate in cross-functional projects as the ICMR 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 ICMR 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 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.

Koho hledáme

Education Requirement: M.D. or equivalent Ex US degree in Medicine
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

Plný úvazekSenior