Work Flexibility: Remote or Hybrid or Onsite
Stryker's Neurovascular Division is seeking to hire a Senior Staff Medical Safety Specialist in Fremont, California or remotely anywhere in the United States. Who we want:• Meticulous documenters.
Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations. • Collaborative partners.
People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions. • Analytical problem solvers.
People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues. • Dedicated achievers.
People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations. • Curious learners.
People who seek out cutting-edge research and information to expand and enhance their ability to develop new ideas into reality.
The Senior Medical Safety Specialist is responsible for providing medical expertise and assessment to support patient safety throughout the life cycle as both an advocate for patient safety and in support of safe and effective use of neurovascular products and therapies. Represent Safety function on clinical project teams. Maintain responsibility for managing serious and major adverse event reporting for investigational and marketed devices. Work with confidential patient and company data. Internally interface with cross-functional clinical project teams.
WHAT YOU NEED:
- Demonstrate advanced ability to apply domain competencies in an effective and consistent manner with tasks such as rating harms and hazards within documents, NC, PFA/HHE, NPD etc.
- Evaluate complex, unique, or ambiguous adverse events or potential safety signals identified through Quality, Clinical, PMS, and Regulatory related business unit processes
- 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 and action.
- Provide evidence-based medical safety input, education and/or response to safety inquiries from internal or external stakeholders
- Provide input to the Medical Safety function strategy, participates in, and leads initiatives that contribute to Medical Safety success
- Develop trial protocol, case report forms, complaint management plan, and final study report in collaboration with core clinical trial team
- Author clinical trial Safety Plan, Clinical Events Committee Charter, Data Management Committee Charter
- Assess and triage adverse events, escalating to committee(s) as appropriate; reconcile adverse events with SAE database according to established guidelines
- Author narratives for Clinical Events Committee adjudication and Regulatory filing
- Prepare for and run Clinical Events Committee and Data Management Committee meetings
- Assess and trend in-trial patient risk and report to post-market surveillance as appropriate
- Act as subject matter expert and consultant to Clinical Research Associates and other internal and external stakeholders
- Maintain safety database and analyze metrics for reporting
- Collaborate with other staff to resolve complex or unclear situations
- Propose and participate in departmental continuous improvement initiatives
- Perform formal literature searches and summarize articles
- Assist in training staff
- Bachelor's Degree required; in a health/science-related field preferred.
- A MD, RN, or MPH preferred.
- A Master's or Ph.D. degree in health/science-related field preferred.
- 6+ years of combined experience in clinical research, clinical trials, medical safety or post market regulatory required.
- Strong medical and narrative writing skills preferred.
- Experience in adverse event reporting strongly preferred.
- Experience in IDE / Class III product clinical trials preferred.
- Experience with electronic data capture and safety databases preferred.
- Vascular experience preferred.
- Must be able to think analytically, have the ability to process scientific and medical data, with the ability to multi-task and problem solve.
- Must be able to work and make independent decisions, understand complex medical information, and be able to take the initiative to lead projects and assignments.
- Excellent organizational, project and time management skills.
- Excellent working knowledge of regulatory guidelines (FDA/CFR; EN540/GCP), and medical terminology.
This job may be performed remotely from anywhere in the United States, except that this job may not be filled or performed in Colorado.
Travel Percentage: 10%
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.
Stryker is driven to work together with our customers to make healthcare better. In order to fulfill our commitment as a federal contractor, while focusing on the health and safety of our employees and those that we serve, Stryker is encouraging US employees as well as all new US employees joining our company to be fully vaccinated against COVID-19. Today or in the future, vaccination may be a requirement based on the essential functions of the specific role or applicable regulations. Please refer to our COVID-19 Vaccination Requirements FAQs page for current vaccination and/or reasonable accommodation requirements and timelines.