Paragon Europe is seeking to recruit a Reviewer, Safety (MDV) for one of our clients within the Healthcare and Pharmaceutical industry.
This section focuses on the main purpose of the job in one to four sentences.
Provide safety (medical) review for individual complaints involving patient harm with the use of the company's medical devices (clinical and spontaneous), including medical term coding, seriousness, expectedness and causality assessment for an assigned therapeutic area.
Ensure that appropriate medical interpretation and consistency are applied to medical device-related adverse event case assessments.
Work with clinical counterparts in the assigned therapeutic area as needed, including but not limited to review of serious adverse event handling.
Be an expert for assigned medical devices, maintain current knowledge of full product portfolio and safety profiles for products.
Communicate and interact effectively within and across Therapeutic Teams, and within Functional Team Management as appropriate
Support internal and external customers related to the evaluation of medical device safety issues and adverse events potentially associated with licensed products safety and performance
Essential Duties and Responsibilities:
This section contains a list of five to eight primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned.
Provide medical review of individual medical device complaints resulting in the patient, user or third party harm, including medical term coding, seriousness and causality assessment. Ensures that appropriate medical interpretation, adequate product and therapeutic area knowledge and consistency are applied to device-related adverse event case assessments.
Assess the need for additional safety investigation (clinical follow up) and lead the clinical investigation for individual medical device complaints resulting in the patient, user or third party harm.
Support internal and external customers related to the evaluation of medical device safety issues and adverse events potentially associated with licensed products safety and performance.
Share medical/clinical expertise with counterparts in other functional areas such as quality assurance, regulatory affairs, marketing, manufacturing, and legal globally.
Ensure fast communication of all medical device safety related issues to appropriate stakeholders (MDV Medical Safety Officers), including support for the Important MDV Safety Communication.
Maintain knowledge of medical device reporting regulations worldwide (especially FDA’s CDRH and European Commission MDD), risk management standards, and quality management systems.
Contribute to the training and continuing education for new departmental staff.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
In-depth knowledge of medical device adverse event processing including triage, investigation, medical assessment and submission to regulatory authorities.
Knowledge and understanding of medical device regulations and regulatory guidelines and/or guidance.
Awareness, and preferably working knowledge, of coding dictionaries (e.g., MedDRA)
Experience with commercial databases and the ability to work in an enterprise cloud-based collaboration environment (box.com)
Good analytical and problem-solving skills
Excellent oral and written communication and interpersonal skills
Medical writing expertize
Ability to adapt and drive constant change for continuous improvement
Education and/or Experience
Include the education and experience that is necessary to perform the job satisfactorily.
Healthcare professional (RN,) preferably with a Bachelor’s degree in nursing (US only) or equivalent.
At least 5 years of medical professional experience (hospital, patient care, or equivalent experience), including 2 years related clinical, safety or regulatory experience in the medical device industry.
Knowledge of at least two therapeutic areas (Medication Delivery, Nutrition, Surgery, Anesthesia Critical Care, Renal: APD/CAPD and/or HD)
Experience with multicultural teams, able to manage multiple tasks, and ability to influence in a cross-functional team setting.
Knowledge and understanding of national and international medical device regulations and regulatory guidelines
Working relationships with and exposure to various Regulatory Authorities worldwide
Knowledge of medical aspects of medical device safety, medical device vigilance in pre- and post-marketing safety practices