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MEDIC001536 Medical Safety & Risk Management Physician - Florham Park, NJ

Job Information

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# of Positions :
Minimum Education Level :
Experience Required :
Duration :
Full Time Regular
Shift :
First Shift (Day)
Hours per week:
Start Date :

Job Description


The Medical Safety and Risk Management Physician will report into the Medical Safety and Risk Management Lead and serves as the primary medical reviewer for all assigned Shionogi projects and products ranging from investigative through post-marketed status. Will contribute to the analysis, review, and approval of Individual Case Safety Reports (ICSRs) and maintain active medical safety oversight for assigned products.
Performs medical review and assessment of adverse event reports for marketed and investigational products, adhering to documented procedures and company/partner timelines; accountable for seriousness, causality, listed assessments and medical accuracy in all Adverse Event (AE) case assessments.
Performs review and clarification of trial-related AEs, medical case review of Serious Adverse Events (SAEs), including review of case documentation, narratives and AE coding.
Ensures medical accuracy of case narratives, coding and medical sense of all cases and ensures appropriate queries are raised to expedite case closure.
Conducts scientific literature review as part of signal detection activities.
Participates in development and maintenance of risk management plans(RMPs) and REMS and oversight of critical safety issues and benefit-risk assessments.
Provides medical content and review of aggregate safety reports such as PSUR, DSUR, PADER, and other periodic reports and ensures the overall quality of documents.
Maintains current working knowledge of global drug development and pharmacovigilance guidelines and regulations, especially in regions of company product development and/or marketing (US FDA, PMDA, EMA, MHRA, ICH, etc.).
Assists in preparing and may present product safety issues at meetings, as needed .
Assists in the creation, review and implementation of new SOPs, Work Instructions, guidelines, documents and other tools pertaining to safety.
Provides support for preparation of regulatory documents and responses to regulatory inquiries, licensing activities, regulatory inspections, product quality complaints, and project or product recall activities.
MD or DO from accredited institution of Medical Education (board certified preferred; board eligible or OUS equivalent) with a minimum of 1 year of clinical experience.
A minimum of 3 years of experience in Pharmacovigilance/Drug Safety with development and marketed products in a biopharmaceutical industry setting.
Strong ability to understand and evaluate technical, scientific and medical information; and understand the safety/medical implications; exposure to clinical data collection, assessment, and analysis.
Proficiency with ARGUS safety database, MedDRA coding, Microsoft Excel, Word, and PowerPoint.
Proficiency in verbal and written communication with some experience in presentations.
Excellent teamwork and collaboration skills.
Ability to make responsible decisions to protect Companys liability exposure and to represent company in a professional manner.
Ability to manage urgent and unexpected crisis safety situations/alarms and to identify issues and take appropriate actions.
Flexible work arrangements will allow for work from home, but we suggest you live a commutable distance to our offices in Florham Park, NJ -- to allow for your convenience on days when you are required or need/want to work onsite.
To be considered for this position, you must apply and meet the requirements of this opportunity.
We look forward to reviewing your resume & qualifications.
Please be aware that Shionogi Inc. mandates COVID-19 vaccination of all employees and contractors regardless of work location. Accommodations may be made in accordance with applicable law.
The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilitiesmay change or be assigned at any time with or without notice.
Shionogi Inc. is an equal opportunity/affirmative action employer.
All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law.
It is the policy of Shionogi Inc. to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractors legal duty to furnish information. 41 CFR 60-1.35(c)

Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity

Company Information

Name :
Description :
See job description
Type :
Direct Employer
Address :
300 Campus Drive
Suite 300
Florham Park, NJ 07932

Application Information

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Job Posting Entered On :
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