Johnson & Johnson Hiring for Medical Safety Specialist at Danvers, MA Full Time

Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed’s “Patients First!” culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.

I Am Abiomed | I Am Heart Recovery | Patients First!

The Medical Safety Specialist reports into the Medical Safety Department within the Regulatory & Clinical Affairs function and is responsible for implementing and executing the safety functions and responsibilities for the medical and clinical research programs.

Job Responsibilities:

• Leader and subject matter expert in clinical trial safety (designated trials):
• Management of safety related clinical trial activities: Conduct medical reviews of events reported in clinical trials, post-market databases, and other sources. Ensure timely and accurate execution of safety processes, adverse event and medical record reviews and assessments; manage safety requests for source documents, management of safety queries, track safety activities to study timelines, manage or contribute to development and ongoing review of study related documents and case report forms, event reconciliation between EDC and Quality Assurance/Complaints, and other clinical trial safety activities as directed.
• Develop and implement Safety Management Plan (SMP)
• Review of draft informed consent forms (templates and site specific)
• Activities related to study committees (CEC, DSMB/DMC, Independent Medical Monitor) which may include creation/management of committee charters, creation/review of adjudication narratives, managing member contracts, training and committee meetings or overseeing third party management of committee activities.
• Management of Independent Medical Monitor activities per associated Charter
• Responsibilities may include management and coordination of Abiomed led CEC activities which may include, but are not limited to, management of committee members, scheduling and oversight of meetings, oversight of preparation of meeting materials (e.g., agendas, minutes, adjudication dossiers), data base entry/verification, coordination of CEC related activities with study lead safety specialist and CEC process improvement activities.
• Work with regulatory affairs and clinical operations, or third-party managing safety reporting, to ensure accurate and timely reporting of AEs, SAEs and UADEs per study and regulatory requirements
• Collaborate with Medical Affairs clinicians and Medical Safety Director to prepare safety response letters and medical to medical communications.
• Support the design, authoring, implementation, and execution of standard operating procedures (SOPs).
• Comply with guidelines, standards and regulations that are applicable to medical devices and medical device clinical trials.
• Contribute to the development and implementation of medical safety program initiatives, process improvements and sound safety practices.

Qualifications

• Bachelor’s Degree in Nursing or life sciences required; Advanced degree preferred
• Deep understanding of safety regulations, including 21CFR803, 21CFR812, MEDDEV 2.7.3, MEDDEV 2.12, ISO 14155 and EU MDR.
• Minimum of 3 years of implementing medical device safety processes or 5 year of clinical research experience including management of safety events
• Experience managing processes for CEC and DSMB/DMC
• Additional experience desired in complaint handling, quality & regulatory systems, or related
• Effective analytical and problem-solving skills; Ability to work with a minimal amount of supervision; Well-developed written and communication skills
• 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)

Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. Abiomed maintains a drug-free workplace.