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Medical Safety Specialist, Literature

Medical Safety Specialist, Literature
Mansfield, Massachusetts, United States
Requisition #:
Post Date:
Nov 29, 2018
Careers That Change Lives
This position is primarily responsible for providing support of activities supporting compliance to the Medical Device Regulations.
The Medical Safety Specialist is primarily responsible for providing review of medical literature for Post-Market Product Surveillance. This position will continually monitor the safety and risk/benefit profile of products distributed, marketed and sold by Medtronic?s Minimally Invasive Therapies Group (MITG). You will collaborate with multiple functions including Research and Development, Risk Management, Quality/Post-Market Vigilance (PMV), Regulatory, and Clinical Affairs.
A Day In The Life
You will apply your medical knowledge, clinical expertise, and product knowledge to support patient safety through the application of:
Medical Input:
+ Maintain medical knowledge in medical specialties, diagnoses, treatments and procedures related to product and therapy areas.
+ Conduct post market literature surveillance from a variety of product data sources including clinical, post-market complaints, legal, and medical/scientific literature.
+ Review of literature for both branded, and competitive products (including competitive recalls/ field safety notices).
+ Leverage medical knowledge and advocate for patient safety by providing medical safety input to internal functions and business processes across the product life cycle where the Medical Safety role is defined.
Medical Safety Assessments:
+ Evaluate events and potential safety signals identified through literature notifying Post Market Vigilance (PMV), Quality, Clinical, and Regulatory related business unit processes.
+ Collaborating with other members of the team/ cross-functional teams who are authoring high quality and accurate safety assessments per business unit processes, leveraging complaint data, literature, registries, or other data sources as appropriate.
+ Critically assess and escalate newly identified safety issues (suspected increase in severity and/or frequency of known events or new event with causal relationship to the device) per business unit processes for investigation assessment and action.
+ Assist with obtaining input from external medical and subject matter experts on safety matters.
Safety Inquiries:
+ Provide evidence-based medical safety input, education and/or response to safety inquiries from internal or external stakeholders (e.g., external medical personnel or other third-parties, including regulatory agencies or health care organizations).
Product and Therapy Knowledge:
+ Acquire and maintain proficient knowledge of assigned products and therapies, such as device design and function, product labeling, indications, mechanism of action, care pathways, and overall safety profile (i.e. hazards and harms).
+ Actively acquire and maintain knowledge of relevant scientific literature associated with assigned devices/therapies.
Business Acumen:
+ Acquire and maintain advanced knowledge of applicable business unit policies/procedures, and relevant regulatory requirements and guidelines (e.g., ISO 14971, Application of Risk Management, ISO 13485, Quality Management Systems).
+ Maintain an advanced understanding of key business processes involving medical safety (e.g., risk management, post market vigilance).
+ Work effectively across the matrix
+ Develop solutions and lead opportunities to advance and improve safety practices. May lead other projects as assigned in part or in entirety that span outside of medical safety.
+ Medical Communication and Influence:
+ Lead and influence evidence-based medical decision making across the matrix organization.
+ Provide strategic input and influence business strategies to optimize Medical Safety value.
+ Interpret, analyze, and effectively communicate medical assessment across a variety of levels and audiences.
+ Adapt verbal and written communication style to situational context.
+ Adapt to changing priorities and work demands.
Must Have; Minimum Requirement
+ Licensed healthcare professional or certified personnel with clinical knowledge and relevant patient care experience.
+ Bachelor?s Degree RN, RT
+ Combination of Licensure and Medical Affairs/Safety or Clinical Management experience
+ Certified Professional In-Patient Safety, CPPS (within 1 year of hire)
+ Minimum of 5 years relevant experience in direct patient care.
+ Ability to perform patient assessments
+ Solid medical background with the ability to understand complex disease states and different treatment outcomes and complications.
+ Excellent verbal and written English communication skills
+ Proficient in Microsoft Office applications including Microsoft Word and Excel and ability to learn new document systems/solutions.
Nice To Have
+ 3+ years preferable experience in the medical device industry.
+ Good understanding of regulatory guidance from European Medicines Evaluation Agency (EMEA), Food and Drug Administration (FDA).
+ Advanced Degree
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

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