Job Information
AbbVie Associate Medical Director, Device Safety in Pleasanton, California
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
I ndependently responsible for the proactive safety strategy and medical safety aspects of one or more medical device s including medical risk management, signal detection, development of marketed products and safety oversight of clinical studies. Will w ork in close collaboration with cross-functional teams and counterparts in regulatory, clinical development, manufacturing, quality, product support, and other functional areas to identify, evaluate, and communicate safety issues.
Responsibilities:
Understanding and application of device design, risk and clinical effects and safety to effectively conduct safety surveillance
Safety surveillance for device/drug –device combination products/IVDs/Digital Health Tools
Contribute to the authorship of key device safety documents, including but not limited to, medical safety assessments, regulatory responses, and risk management documents
Apply current regulatory guidance as appropriate for safety surveillance and authorship of MDS documents
Analyze and interpret aggregate safety data and communicate these analysis and interpretation to cross-functional teams
Write, review, and provide input on technical documents and safety communications
Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Qualifications
Qualifications:
MD / DO with 2+ years clinical practice Board Certification in current area of practice preferred
Prior device safety experience is preferred in addition to MD / DO
Effectively analyze clinical data and epidemiological information required
Effectively write technical documents with direction
Work collaboratively in a team environment and be self-starting and able to work independently
Ability to effectively present recommendation/opinions in a group environment
Fluency, both written and oral, in English
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.
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 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.
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