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Sr Medical Affairs Spec - Exempt
Virtual Location Sarasota, FL 34232 US
Job Description
(Pay 56.50-64/h depending on experience)
Nice to have is FL - near Miami Lakes but not required
HM's Top Needs:
-
5 years VAD experience
-
Active medical license RN/PA/NP etc.
-
Hands on patient care/bedside experience - within the past 10 years
Education Required: Education comensurate to earning a Medical License
Yearsrsquo Experience Required: MInimum 5 years
Senior Medical Safety Specialist supporting Mechanical Circulatory Support ndash Remote Option/Contingent with potential to full time. Careers that Change Lives
We are seeking a Senior Medical Safety Specialist a fully remote opportunity medical expertise and assessment to support patient safety throughout the lifecycle as both an advocate for patient safety and in support of safe and effective use of H/LVAD devices. You will collaborate with multiple functions including Research and Development Risk Management Quality/Post-Market Vigilance Regulatory and Clinical to help deliver against our highest quality standards.
The Senior Medical Safety Specialist works with minimal supervision on a range of medical safety activities of varying complexity in collaboration with Medical Safety team members and other functions including Regulatory Quality/Post-Market vigilance Risk Management Complaint Handling Product Development and Medical Affairs. They primarily interact with MS team members Medical Safety Medical Directors and Specialists and other functions as needed to share information or gain input to support decision-making on various aspects of patient safety. They may occasionally interact in a supportive role with external physicians.
A Day in the Life You will apply your medical knowledge clinical bedside expertise and product knowledge to promote patient safety through the following activities:
- Leverage medical knowledge and advocate for patient safety by providing input to internal functions and business processes across the product life cycle promoting product safety.
- Apply knowledge of HeartWare Ventricular Assist Device and/or Left Ventricular Assist Device LVAD management.
- Evaluate events and potential safety signals identified through Quality Clinical and Regulatory related business unit processes.
- Author 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 per business unit processes for investigation assessment and action.
- Assist with obtaining input from external medical and subject matter experts on safety matters.
- Complete qualitative and quantitative assessments of post-market adverse events medical significance and recommendations for inclusion in regulatory annual reports.
- 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.
- 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.
- Acquire and maintain advanced knowledge of applicable business unit policies/procedures 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 a matrixed organization.
- Develop solutions and lead opportunities to advance and improve safety practices.
- May lead other projects that span outside of Medical Safety as assigned in part or in entirety.
- 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 various levels and audiences.
- Adapt verbal and written communication style to situational context.
- Adapt to changing priorities and work demands.
- Travel is required. Less than 10.
Must Have: Minimum Requirements
- Bachelorrsquos degree required in Nursing or related healthcare field.
- Licensed healthcare professional in related healthcare field.
- Proficient knowledge of cardiac disease states managed by a mechanical pump.
- Combination of Licensure and Medical Affairs/Safety or Clinical Management experience.
- Proficient knowledge of LVAD including heart rhythm interpretation device programming failure modes and medical complications and implant procedural workflow.
- Minium of 4 years of relevant LVAD management experience including implant procedures programming and device management in a clinic or hospital setting or advanced degree with minimum of 2 years of similar relevant experience.
Nice to Have
- Ability to perform patient assessments.
- 3 years experience specifically in the medical device industry preferred.
- Ability to understand and apply practical medical and product knowledge in a competent manner for Medical Safety activities.
- Able to make competent risk-based and timely medical safety decisions based on insightful analysis of critical information able to balance analysis with decisiveness.
- Able to understand scientific/technical concepts and function of medical devices.
- Excellent verbal and written communication skills to effectively convey message and influence diverse stakeholders.
- Versatile learner able to quickly and effectively integrate new information and skills.
- Divergent thinker with solid critical thinking and problem-solving skills. Must be able to reach determined goals by prioritizing workload effectively and independently.
- High attention to detail and accuracy able to work independently with minimal supervision accountable for outcomes.
- Able to develop trusted relationships and collaborate with peers co-workers and key functional partners.
- Good understanding of regulatory guidance from European Medicines Evaluation Agency EMEA Food and Drug Administration FDA.
- Proficient in Microsoft Office applications including Microsoft Word and Excel and ability to learn new document systems/solutions.
- Command of basic statistical and data analytical assessments.
The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.
Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.
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