Position Description The Sr. Medical Safety Specialist serves as a medical resource and safety advocate to communicate, educate and recommend safety improvements with internal functional groups and external customers to improve the safety profile of Neuromodulation’s products and therapies. This position requires a bachelor’s degree in science/health care related field with excellent clinical background. Knowledge and experience in post-marketing device and/or pharmaceutical safety reporting and risk management principles is of benefit. A key responsibility of this position is completion of annual therapy safety reviews based on analysis, integration and interpretation of cumulative post market adverse event information and product/therapy performance information in order to maintain an accurate safety profile of Neuromodulation’s products and therapies. Ongoing responsibilities include safety assessments of post market adverse events and potential safety signals, scientific literature review, collaboration with internal functional groups to support complaint evaluation, health hazard assessments, post market vigilance and quality teams, and interactions with external customers, including expert physicians, local and national reimbursement bodies, and Regulatory Agencies (such as FDA). This position reports into the Medical Safety Surveillance department and receives medical direction and guidance from the Medical Safety Program Sr. Director (M.D.).
Position Responsibilities Duties and Responsibilities: •Complete annual medical safety reports that include an integrated and interpreted qualitative and quantitative assessment of post market adverse events and medical device events and recommendations for improving the safety profile of Neuromodulation’s products and therapies •Complete safety analysis of adverse events or potential safety signals identified through data trending or complaint evaluation teams •Serve as a medical consultant and patient safety advocate through active involvement in multifunctional teams including Clinical, Quality, Risk Management, Complaint Management •Provide guidance to other functional groups to optimize the quality and utility of safety data available for the annual medical safety reports •Prepare medical safety summaries and present at physician safety panels •Acquire and maintain knowledge of assigned products/products and therapies, labeling, diseases treated, indications, risks and mitigations •Review scientific literature to assess the quality and quantity of adverse events •Partner with Quality and provide medical input in the development of field action plans and safety communications; provide guidance to quality issue investigation teams to identify events of interest •Maintain knowledge of relevant regulations and guidelines, including ISO 14971, FDA and ICH guidelines for classifying and reporting medical device and drug adverse events •Contribute to the development and implementation of safety program initiatives, process improvements, and sound safety principles and practices •Work independently under general direction from direct manager; appropriately escalate safety issues to management.
Basic Qualifications •Bachelor’s degree in science/healthcare related field (e.g., nursing, paramedical, R Ph, medical safety liaison) and 7+ years in patient management or leadership role with excellent clinical background •MD, Physician Assistant, Pharm D or Nurse Practitioner with 3-5 years patient management experience •Demonstrated effective scientific writing •Work experience in Microsoft Office Word, Powerpoint, and Excel
Desired/Preferred Qualifications •Strong analytical and critical thinking skills •Specialty training/certification in neurological disease, pain management or infusion technology. •Masters in Public Health, epidemiology, or advanced statistical training •Experience in patient safety, data safety monitoring boards or safety physician panels •Experience in clinical trial safety, device or drug regulatory agency or industry, risk management or pharmacovigilance (PSUR, IND Annual Reports, NDAs, PMAs) •Understanding and knowledge of basic statistical analyses, clinical trial design, and standard adverse event coding classification systems and toxicity scales •Ability to interact effectively and professionally with cross functional teams and external customers and stakeholders •Project management experience •Demonstrated ability to deliver results; self-starter, multi-tasker •Excellent attention to detail and organizational skills •Experience in presentations at scientific meetings as well as publications •Proficiency MeDRA, World Health Organization Adverse Event dictionary, Common Terminology Criteria for Adverse Events, and others as needed
Physical Job Requirements •Stand/Sit 8 hours
Thank you for your interest in the Senior Medical Affairs Specialist position.
To begin the application process, please enter your email address.
Email: Email is invalid Email is needed
By applying to a job using CareerBuilder.com you are agreeing to comply with and be subject to the CareerBuilder.com Terms and Conditions for use of our website.