Reviewer, Safety (MDV) - Health & Fitness jobs in Malta - April 2019
Recruitment Agency
Paragon Europe

Reviewer, Safety (MDV)

Healthcare,
Medical
Posted date 04/04/2019 |
Closing date 04/05/2019
Full Time Experienced, Graduate

Paragon Europe in Malta is seeking to recruit a Reviewer, Safety (MDV) for one of their clients within the Healthcare and Pharmaceutical industry on a full-time basis. 



The main purpose of the job:

  • 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;
  • Interact with medical professionals and healthcare facilities to investigate individual cases of device-related serious adverse events in accordance and in strict compliance with the firm's Global Privacy Policy consistent with the Safe Harbor Privacy Principles;
  • 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.



Qualifications:

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.


Paragon Europe:
Paragon Europe is an innovative, international EU affairs, advisory and compliance company with head offices in Malta and Brussels. From its inception, Paragon Europe has striven to realise excellence by competing with cutting edge peers in the ultra-competitive market of EU funding. Paragon Europe works with both private and public organisations, NGOs, universities, educational institutes and agencies offering various services related to European funded programmes such as Horizon 2020, Erasmus+, Youth Workers, COSME, PON/POR and more. We assist these organisations with the sourcing and implementation of EU funded projects and tailor our services to each individual requirement ensuring positive results every time. Besides advising public and private organisations on EU funding, Paragon staff also assist good organisations to become great through business and financial advice.

Kindly submit your application directly to us using the 'Apply Now' button.

Share

Health & Fitness Jobs in Malta relate to the provision of health and fitness-related services. Jobs in health and fitness include healthcare, medical, animal care, spa hosts, beautician, cosmetic treatment, fitness, massage therapy, and nutrition roles. Discover more health & fitness jobs in Malta.

This website uses cookies to improve your user experience. By using our website you consent to all cookies in accordance with our Cookie Policy.