Medical Safety Specialist

Abiomed is an innovative medical device company with an inspiring mission "Patients first." and a unique guiding company principle "Regenerating hearts. Saving lives." With 1,800 employees, Abiomed is one of the fastest growing medical technology companies in the world with corporate headquarters in Danvers, USA and locations in Aachen and Berlin, Germany, Tokyo, Japan and Singapore. Abiomed is an employer with attractive working conditions and an appreciative corporate culture that focuses on the needs of its employees. Abiomed inspires and retains exceptional talent through collaboration, passion and continuous development. The Medical Safety Specialist reports into the Assoc. Dir, Clinical Affairs and Programs, EMEA & APAC and is responsible for implementing and executing the safety functions and responsibilities for the medical and clinical research programs. **Responsibilities**: - Go-to person in clinical trial safety (designated trials): includes creation, maintenance and execution of safety management plan, managing safety contracts (CEC, DSMB, monitors, etc) and committee meetings. Ensure timely and accurate execution of safety processes such as initial medical review of events, reconciliation between EDC & safety database, issue/follow up on source queries, track to pre-specified study timelines, aggregate/periodic reporting, process improvements, and other clinical trial safety activities - Supports the design, authoring, implementation, and execution of standard operating procedures (SOPs) - Conduct medical reviews of events reported in clinical trials, post-market databases, and other sources - Participate on cross-functional teams involved in the development or support of products including research and development, quality engineering, medical affairs, clinical research, regulatory affairs and quality assurance - Comply with guidelines, standards and regulations pertaining to medical information provided to customers - Partner with the Head of Global Safety to escalate detected signals and patterns to leadership with recommended next steps - Prepare safety response letters and medical to medical communications together with Medical Affairs clinicians and the Medical Safety Officer - Perform medical record assessment **Job Qualifications**: - Medical or clinical background, preferably with degree - Several years of experience in medical device/medical safety, complaint handling, quality & regulatory systems, or related - Spoken and written fluency in both, German and English - Effective analytical and problem-solving skills; Ability to work with a mínimal amount of supervision - Experience with international clinical studies preferred - Ability to coordinate and lead multiple projects simultaneously - Exceptional interpersonal skills and willingness to work in a team environment - Knowledge and proficient use of Microsoft Office Suite Applications (Word, Excel, Power Point, and Microsoft Project) **We offer**: - Pleasant, open corporate culture with a strong mission: "Recovering Hearts, Saving Lives" - Comprehensive induction program with structured onboarding plan throughout the orientation phase - Company pension allowance of up to 1,500 euros per year and capital-forming benefits - Abiomed shares at a preferential price - Benefit packages for occupational disability insurance and company group accident insurance - Full cost coverage for a job ticket in the Aachen or Berlin area - Various health programs and a leasing option for a job bike ABIOMED is an Equal Employment Opportunity employer. We are committed to the policy of providing equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, disability or national origin.