Utilizes clinical experience and training in patient care to lead or participate in safety signal detection activities aimed at identifying, evaluating, validating, and managing signals for marketed products. This includes conducting individual and aggregate data analyses, interpreting safety signals and trends, and documenting and communicating safety risks in collaboration with key internal and external stakeholders. Draws on previous clinical experience to assess the risks and benefits of medical devices concerning patient safety. May act as a medical reviewer for clinical trials and provide clinical insights to support life-cycle management activities.
ESSENTIAL DUTIES
- Conducts professional medical evaluations of medical device performance, analyzing clinical data from complaints, and assessing the impact on the safety of the company products.
- Performs searches and reviews of adverse event data, literature, and other relevant safety data for signal surveillance and detection.
- Collects and summarizes vigilance data for integration into Quality's Post Market-Surveillance Reports.
- Reviews and contributes to risk and benefit-risk assessments for marketed products, including assessments related to hazardous materials for compliance; oversees safety evaluations impacting patient and donor safety; and prepares risk management plans and reports.
- Reviews and assists with post-marketing aggregate safety reports (PSURs, PADERs, SUSARs, PBRERs, DSURs, IND annual reports) to ensure consistent communication on safety topics across various regulatory documents; reviews safety sections of the Summary of Safety and Clinical Performance (SSCP) and clinical study documents.
- Assists in the development of clinical study documents, including informed consent forms and clinical study reports; supports safety-related activities for pre-market applications and regulatory submissions.
- May contribute to clinical development plans to ensure appropriate medical safety oversight and post-market clinical follow-up (PMCF) studies.
- Collaborates with cross-functional teams on risk minimization strategies and may provide clinical insights during product development.
- Participates in relevant Health Hazard Evaluations and field action/recall activities.
- Engages with Clinical and Scientific Affairs to support product life-cycle management goals.
OTHER DUTIES AND RESPONSIBILITIES
The GMS Clinician may also perform or assist with medical monitoring functions for clinical studies, including:
- Reviewing adverse events (AEs) and serious adverse events (SAEs) to assess device and study relatedness and expectedness.
- Providing input on clinical development plans, protocol design, and risk assessments.
- Assisting in clinical data management, including MedDRA and WHO DD coding.
- Reviewing study deliverables such as final narratives and clinical study reports.
- Analyzing safety and efficacy trends across various clinical trials.
- Acting as the medical monitor contact for investigators and study sites regarding protocol compliance and participant safety.
MINIMUM QUALIFICATION REQUIREMENTS
Education
A degree appropriate for a licensed healthcare professional (e.g., BSN/RN, MSN/RN, Nurse Practitioner) or equivalent education and experience sufficient to perform essential job functions. An advanced degree in Epidemiology, Biostatistics, Health Surveillance, Patient Safety, or Medical Quality is preferred.
Experience
- Minimum of 3 years of clinical/hospital experience after postgraduate training.
- Preferred: Two years in a medical safety role within the pharmaceutical, biotech, or medical device sectors, with experience in transfusion medicine, blood banking, cellular therapy, and/or apheresis.
Skills
- Comprehensive knowledge of global regulations and reporting requirements related to medical device and pharmacovigilance, including signal detection and risk management activities.
- Understanding of drug/device development and lifecycle management processes.
- Familiarity with therapeutic areas related to the company products.
- Strong clinical and scientific judgment.
- Ability to apply medical terminology and concepts in various contexts.
- Proficient in analyzing datasets, interpreting results, and clearly communicating complex scientific information to diverse audiences.
- Capable of gathering data from multiple sources, creating case narratives, and conducting risk assessments.
- Effective teamwork and self-direction, with the ability to work independently.
- Proficient in relevant PC software applications.
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