Medical Director, Medical Device, Patient Safety

Medical Director, Medical Device, Patient Safety

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Company

Description:

Abb Vie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas—immunology, oncology, neuroscience, and eye care—along with products and services in our Allergan Aesthetics portfolio.

Location:

Lake County, IL (Abb Vie Headquarters) and open to other Abb Vie office locations in the US.

The Medical Device Safety Physician leads safety oversight for assigned products, advising on courses of action to meet safety goals. Working closely with cross‑functional teams—quality systems, regulatory affairs, medical writing, clinical development, clinical operations, manufacturing, epidemiology, marketing, and others—identifies, evaluates, and communicates safety issues. May provide clinical safety input to new product design teams as needed. Independently responsible for proactive safety strategy, medical safety assessment of SAEs/AEs reported to Product Surveillance, clinical study safety management, post‑market surveillance activities, regulatory reporting, lifecycle safety risk management strategies, and communication of safety information for assigned products.

• Responsible for safety aspects of clinical trials, including drafting/reviewing the Safety Management Plan and relevant safety chapters/text of key clinical trial documents such as informed consent and protocols.
• Evaluate all safety data generated in clinical trials on a contemporaneous basis.
• Provide medical leadership on global teams on safety‑related issues.
• Conduct overall evaluation, assurance, and reporting of safety for subjects in clinical trials and the development program.
• Perform medical assessment of Serious Adverse Events—including causality assessment, determination of expectedness, identification of events of interest, sentinel events, and additional follow‑up for pre‑ and post‑market products as appropriate.
• Provide medical safety input to Global Product Teams regarding expectedness, causality, data reconciliation, and analysis of safety data.
• Review and approve final listings of SAEs, AEs, AE of special interest, and other listings based on the clinical study requirements.
• Respond to safety questions from investigator sites and IRBs regarding safety issues and queries.
• Interpret safety findings for all clinical study reports, including final review of safety‑relevant adverse event coding and propose revisions or additions.
• Contribute to integrated safety summaries, risk‑benefit assessments, and other relevant safety sections in support of regulatory submissions and reports.
• Ensure accurate, relevant, and meaningful CSR data and insights.
• Liaise with assigned Data Safety Monitoring Boards.

• Ensure appropriate assessment of product complaints requiring medical interpretation for assigned products.
• Document medical assessment and determinations prior to submission of reports, including MDRs, to regulatory authorities.
• Provide medical input for regular and ad‑hoc product surveillance and safety reports for publication to regulatory authorities.
• Support reportability decisions and accurate coding for device adverse events and malfunctions.

• Contribute to assessment of newly identified and potential risks for development of risk‑management plans and risk‑minimization activities.
• Contribute to development and ongoing review of assigned product(s) Clinical Hazard Lists and Failure Mode and Effects Analysis.
• Review device risk‑management documents such as AE Matrix, Risk Management Plans, Risk‑Benefit Analysis, Design & Process FMEAs, and Risk Management Reports.
• Participate in Health Product Hazard Assessments and Health Hazard Evaluations.
• Support writing safety responses to regulatory authorities.
• Review literature to support submission of new device applications.