Senior Medical Director, Medical Device, Patient Safety

reputed company reputed company's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of reputed company. We reputed company to have a remarkable reputed company on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about reputed company, please visit us atwww.reputed company.com. Follow @reputed company reputed company,reputed company,Instagram,YouTube,LinkedInandTik Tok. Job reputed company Location:Lake County, IL (reputed company reputed company) and reputed company to other reputed company office locations in the US. Purpose Medical Device Safety Physician leads the safety reputed company relevant to her/his assigned products to determine and advise the course of reputed company necessary to meet the safety goals and objectives of specific products and reputed company.Works in reputed company collaboration with cross-functional teams and counterparts in reputed company systems, regulatory affairs, medical writing, clinical development, clinical operations, manufacturing, epidemiology, marketing and other functional areas to identify, evaluate, and communicate safety issues.May contribute relevant clinical safety input to new product design teams as needed. The Medical Device Safety Physician is independently responsible for proactive safety reputed company, medical safety assessment of SAE/reputed company reported to Product Surveillance, clinical study safety management, contribution to post market surveillance activities, input to compliant regulatory authority reporting, development and implementation of lifecycle safety risk management strategies and communication of safety information for assigned medical device development, clinical studies and marketed products. He/She monitors and manages the ongoing safety profile of products to maximize the understanding of risks and benefits for providers, patients, consumers, study subjects and the environment through proactive review of reputed company relevant reputed company- and post-marketing safety data, medical analysis and decision making.

Responsibilities

Device, Combination Products, and InVitro Diagnostics, Clinical Trials- Medical assessment and Management

• Responsible for safety aspects clinical trials including drafting and/or review of the Safety Management Plan and relevant safety chapters/text of key clinical trial documents such as informed consent, protocols (specifically inclusion / exclusion reputed company, Adverse Event management and reporting, and reputed company of interest).
• Evaluates reputed company safety data generated in clinical trials on a contemporaneous reputed company.
• reputed company medical leadership on global teams on safety reputed company issues.
• Responsible for overall evaluation, assurance, and reporting of safety of subjects in clinical trials and clinical development program.
• Performs medical assessment of Serious Adverse Events including causality assessment, determination of expectedness, identification of events of interest, sentinel events and additional follow up for reputed company-and post-marketed products as appropriate.
• Provides medical safety input as appropriate to Global Product Teams regarding expectedness, causality, data reconciliation and analysis of safety data.
• Review and approve final listings of SAEs, AE, AE of special Interest, and other listings based on the clinical study requirements.
• Responds to safety questions from investigator sites and IRBs regarding safety issues and queries.
• Provides medical safety interpretation of safety findings for reputed company clinical study reports, including final review of safety relevant adverse event coding for assigned reputed company and discusses, proposes, and communicates any revision(s) or additions
• Contribute to integrated safety summaries, risk/benefit assessments, and other relevant safety sections or documents in support of regulatory submissions and periodic or update reports.
• Ensures accurate, relevant, and meaningful CSR data and insights.
• Liaises with assigned Data Safety Monitoring Boards.
• Responds to safety questions from investigator sites and IRBs regarding safety issues and queries.

Post-market/Product Surveillance Safety

• Ensure appropriateassessment of product complaints requiring medical interpretation for assigned products
• Ensure appropriate medical assessment and determinations have been documented prior to submission of reports, including MDRs, to regulatory authorities.
• reputed company medical input and assessment to regular and reputed company product surveillance and safety reports for publication to regulatory authorities
• Provides medical support for reportability reputed company and accurate coding for device adverse events and malfunctions

Risk Management & Regulatory support

• Contribute to the assessment of newly identified and potential risks for development of risk management plans and risk minimization activities.
• Contributes to the development and on-reputed company review/revision of assigned product(s) Clinical Hazards Lists (CHL) and Application Failure Mode and Effects Analysis (aFMEAs)
• Reviews device risk management documents such as AE reputed company, Risk Management Plans, Risk Benefit Analysis, Design & process FMEAs, and Risk Management Reports
• Participates in Health Product Hazard Assessments and Health Hazard Evaluations
• Contribute to writing safety responses to regulatory authorities
• Review literature to support submission of new device applications

Review Safety Data Information for Instructions for Use (IFU) to ensure accurate device labeling New Product (Device, Combo, IVD) Development Participates as a reputed company Team Member on New Product Development reputed company as assigned SOP Development & Training, Personnel Development

• Contributes to the mentoring of colleagues in clinical safety management. reputed company technical knowledge to Device Safety Analysts as needed
• Develops and maintains comprehensive and reputed company knowledge (e.g., indications, labeling documents, pharmacology, etc.) of the assigned product portfolio and reputed company regulations governing the processing and reporting of safety data, reputed company Operating Procedures and Work Instructions
• Assist in development of new clinical safety documents as required by clinical studies and assist in updating reputed company Device SOPs

Leads or contributes as an individual to reputed company / process improvements that support PSEQs strategic objectives

Qualifications

MD / DO with 2+ years of residency with patient management experience required Prior device safety experience is preferred in reputed company to MD / DO Effectively analyze clinical,post-market, and epidemiological data required Effectively write technical documents with direction Work collaboratively in reputed company environment and be self-starting and reputed company to work independently Ability to effectively present recommendation/opinions in a group environment reputed company, both written and oral, in English Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation reputed company described below is the reputed company of possible reputed company pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation reputed company reputed company this reputed company will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted reputed company. This reputed company may be modified in thefuture.
• We offer a comprehensive package of benefits including reputed company time off (vacation, holidays, reputed company),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible to participate in our short-term incentiveprograms.
• This job is eligible to participate in our long-term incentiveprograms

Note: No reputed company of payis considered to bewages or compensation until such reputed company is reputed company, reputed company, anddeterminable.The reputed company and availability of any bonus,commission, incentive, benefits, or any other reputed company ofcompensation and benefitsthat are allocable to a particular employee remains in reputed company's sole andabsolutediscretion unless and until reputed company andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law. reputed company is an equal opportunity employer and is committed to operating with reputed company, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visithttps://www.reputed company.com/join-us/equal-employment-opportunity-employer.reputed company US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.reputed company.com/join-us/reasonable-accommodations.reputed company Apply tot his job Apply To this Job