Job description
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 X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
Serve as Indication Product Safety Lead for one or more products under the direction of Group Medical Director Medical Safety Evaluation. Supporting assigned product with safety expertise through its lifecycle (including during the time of clinical development, marketing registration and post marketing), Interpreting, summarizing and presenting safety data in compliance with the regulatory guidelines.
Responsibilities:
•Understanding and application of pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance
•Responsible for safety surveillance for pharmaceutical / biological / drug –device combined products
•Leading, setting the strategy and, when appropriate, authoring the key documents with safety data, including but not limited to, medical safety assessments, parts of submission dossier and regulatory responses.
•Applying current regulatory guidance as appropriate for safety surveillance
•Analyzing, interpreting, and summarizing aggregate safety data and communicating these analysis and interpretation to cross-functional teams and senior management
•Independently writing, reviewing, and providing input on technical documents
•Providing oversight, leading the strategy as well as authoring when applicable, the key sections for periodic reports (e.g. PSURs, DSURs, PADERs and Safety sections of the IBs)
•Leading and setting the strategy, in collaboration with the development medical lead of study protocols and informed consents
•Defining and implementing risk management strategies for assigned product/indication
•Proactively engaging, inspiring, coaching and mentoring team members and colleagues
•Co-authoring publications and developing and growing as a safety leader
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
Frequent to continuous computer usage (greater or equal to 50% of the workday) is required
Qualifications
•MD / DO with 2+ years of residency with patient management experience; Master Public Health is preferred in addition to MD / DO, not required
•5 - 8 years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry or other relevant experience
•Effectively analyze and guide analysis of clinical data and epidemiological information
•Strong communicator, who is able to effectively present recommendations / opinions in group environment both internally and externally
•Write, review and provide input on technical documents
• Able work collaboratively and lead cross-functional team
•Formulates independent decisions
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 and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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
