Easter Seals Jobs

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

Manager, Medical Device Safety Analytics promotes patient safety through ability to independently review patient safety-related data from medical device/combination products in clinical trials or as part of post-market surveillance. The primary responsibility is to assess the content, quality, and adherence of data to regulatory requirements both in the clinical and post-marketing spaces in addition to supporting the health of device risk files as this position impacts patient safety, product approval, and safety signal identification.

Responsibilities:

• Deliver assigned results for critical priorities and drive high-value projects that make an impact on safety for patients

• Exhibit the Abbvie core leadership attributes: Agile and Accountable; Clear and Courageous; Make Possibilities Real; All for One AbbVie; Decide Smart and Sure

• Maintain understanding of medical device/combination product risk management regulations, as well as applicable standards, and guidance documents

• Understand, implement, and improve department SOPs

• May serve as a representative for Medical Device Safety Management on cross-functional projects but does not assume decision-making responsibilities in the representative role; Contacts may include a variety of multidisciplinary representatives (e.g., Regulatory Affairs, Quality Assurance, Compliance, Engineering, Data Analytics, etc. )

• Responsible for supporting the department, division, and company's strategic direction

• Workload responsibilities are primarily medical device safety management related and include mostly higher level functioning (e.g., prioritizing workflow, training, reconciliation of databases, safety surveillance, risk management review cycle, updates to clinical hazard lists, etc.). Problem solving involving identification of problems, proposed solutions, and appropriate escalation of issues

• Manage others with direction from leadership team by coaching and mentoring designated Medical Device Safety staff

• Other duties may be assigned based on the need or work requirement of the department deliverables

Qualifications

Minimum Requirements:

• Bachelor’s degree with related health sciences or engineering background, RN, BSN, BS

• Candidates lacking the appropriate degree but with previous medical device experience may be considered

• 5-8 years medical device safety experience minimum. Advanced degrees with commiserate work experience would be considered

• Demonstrated ability to lead project work, facilitate cross-collaborative relationships and facilitate meetings with proven success in results-driven process management

• PC proficiency (Windows, Word, Excel) and in EDMS (e.g., oracle/clinical, OneTrack)

• Strong understanding of device regulations as well as quality systems and related risk files

• Critically evaluate medical data and escalate necessary information to Medical Device Safety Physicians as applicable

• Accurately and medically present data, both orally and in writing, with the ability to assign tasks to others in the Medical Device Safety Physician’s absence.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.​

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

• This job is eligible to participate in our short-term incentive programs. ​

• This job is eligible to participate in our long-term incentive programs​

​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html