Pharmacovigilance and Compliance Specialist

Stryker is an exceptional company with exceptional people who deliver exceptional results. We have differentiated ourselves by advancing meaningful innovations, creating cost-effective solutions for and improving the lives of our global customers and patients. As a winner of the 2007 and 2008 Gallup Great Workplace Award, we have demonstrated that Stryker has one of the most productive and engaged workforces in the world. Our exceptional results fuel ongoing opportunities for Stryker employees to build outstanding careers and to develop and grow both personally and professionally. Our work environment attracts many different kinds of talented and driven people who love to win and serve others. We always put quality first. We hold ourselves accountable to reach or exceed our goals and continually improve everything we do. These attributes are shared by the employees that make up Stryker. They are the things that bring us together and serve as the foundation of all we do. And they are the enablers of both our past and future success.

Stryker is one of the world’s leading medical technology companies with the most broadly based range of products in orthopaedics and a significant presence in other medical specialties. The Company's products include implants used in joint replacement, trauma, craniomaxillofacial and spinal surgeries; biologics; surgical, neurologic, ear, nose & throat and interventional pain equipment; endoscopic, surgical navigation, communications and digital imaging systems; as well as patient handling and emergency medical equipment. For more information about Stryker, please visit the company web site at: http://www.stryker.com

The Pharmacovigilance and Compliance Specialist is responsible to ensure that all aspects of IRB processes for any Stryker Biotech product sold under a HDE are compliant with applicable federal regulations and internal SOPs. Responsible for tracking and reporting on related metrics. Responsibilities include investigating, coordinating and responding to technical inquiries in a consistent and timely manner. Will also be responsible for performing additional compliance monitoring related activities as determined by supervisor. Assists with Complaint and Adverse Event case processing including data entry into all applicable databases from initial receipt through regulatory submission Interacts with external and internal customers and vendors. · Responsible for oversight, verification, and maintenance of all IRB approval-related documentation, database maintenance, and surveillance activities· Responsible for oversight of the IRB approval and renewal processes, process development and refinement, and conducting and managing ongoing process reviews· Data entry and oversight of Oracle-based inventory and Pharmacovigilance systems, including Quality checks of data· Develop and deliver internal training for all relevant personnel on IRB process and requirements · Interact with Sales Support, Sales, PV, QA, IT, Distribution, Legal and other divisional functional areas on issues related to IRBs, technical inquiries, product complaints and quality investigation requests · Develop metrics and reporting to demonstrate compliant practices relative to IRB compliance · Track IRB/surgeon communications as related to the IRB process· Primary point of contact for IRB representatives, surgeons and sales representatives· May participate in Pharmacovigilance and Compliance audits, audit responses and corrective actions· Comprehensive understanding of all applicable global regulations · Bring serious or potentially serious adverse events and complaints and any Pharmacovigilance-related issues to the attention of management as necessary and appropriate· Participate in professional and department meetings providing data, assessment, and recommendations for improvement· Additional compliance monitoring related tasks as determined by supervisorMinimum of Bachelors level, or equivalent degree in nursing, pharmacy, or other life science · 1-3 years clinical safety experience in Device, BioPharmaceutical or Pharmaceutical environment · Experience with safety/surveillance activities, knowledge of drug safety regulations and guidelines, etc· Experience with relational database management and data analysis software· Flexibility regarding working hours is required· Excellent interpersonal, communication, planning and organizational skills requiredSee QualificationsStryker is an equal employment opportunity/affirmative action employer committed to hiring a diverse workforce.To read more about Stryker, please visit our website at www.stryker.com