Senior Safety Deliverable Manager

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 . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok .

Job Description

Purpose:

This position reports into the Office of the Product Safety Team (PST) within the Pharmacovigilance and
Patient Safety (PPS) organization’s Global PV Strategy Management Office. The PPS organization works
collaboratively and strategically with colleagues across the product lifecycle to identify, evaluate, understand
and communicate the safety profile of our drugs to protect patients worldwide.

The PST is a high-profile high-impact team that leads and owns safety decisions and strategy across the
product lifecycle. The team partners with stakeholders across the product lifecycle to provide innovative
safety-driven strategies, which will maximize product benefit-risk for patients.

As a Sr. Safety Deliverable Manager within the Office of the PST, you are in a highly visible role that provides
various opportunities to influence and drive operational excellence by providing advanced strategic
management and quality authoring of PST Safety Deliverables.

Responsibilities:

• Demonstrates advanced project management skills and functions autonomously to lead strategy discussions and drive completion of mature and non-mature product safety deliverables (e.g., aggregate safety reports, assessment reports, medical safety assessments) in accordance with regulatory requirements and procedures, and in collaboration with cross- functional stakeholders.
• Applies sound medical judgment to Independently evaluate, interpret, and synthesize complex, high volume scientific data and translate into clear and concise safety summaries for inclusion in mature product safety deliverables.
• Applies solid knowledge and understanding of applicable regulations (e.g., ICH, FDA, EMA,GCP) to independently lead authoring and review of all safety deliverable types in accordance with standard operation procedures.
• Identifies and manages emerging risks and issues that arise during preparation of safety deliverables (e.g., risk to timeline, new regulatory request impacting the deliverable) and ensures they are mitigated and escalated as appropriate.
• Drives document quality through execution of quality control measures (i.e., safety deliverable QC, oversight of stakeholder review, and archival of supporting documents).
• Leverages applicable systems, regulations and processes to enable successful, on-time completion of safety deliverables.
• Functions as a mentor to less experienced Safety Deliverable Excellence team members for authoring complex/non-complex safety deliverables.
• Works and collaborates effectively to build and leverage relationships across functions and organizations to create high quality safety deliverables within specified timeframes.
• Proactively seeks out opportunities to improve overall safety deliverable operational and quality excellence, and leads related inter-department and/or cross-functional process-improvement projects.
• Ensures challenges related to safety deliverable quality, including internal and external feedback, are captured, assessed, and reviewed for improvement.
• Participates in audit and inspection preparation and execution activities.

Qualifications

Required education:
Bachelor’s degree in a Health Sciences discipline (e.g., Pharmacy, Nursing, or other healthcare profession)

Preferred education
Master’s or advanced degree is desirable

Required Experience

• At least 5 years of pharmaceutical industry experience, with more than 3 years of aggregate safety report authoring experience.
• Excellent written and spoken English
• Demonstrated working knowledge of global regulatory framework for aggregate safety reports
• Solid understanding of medical concepts and familiarity with drug development and post- marketing safety activities
• Experience w/ tools, standards and approaches used to evaluate drug safety
• Excellent medical and scientific writing skills with demonstrated ability to effectively analyze, interpret and synthesize complex medical-scientific data and proficiently translate it into a succinct and concise written summary
• Demonstrated ability to operate effectively in a multidisciplinary, matrix team situation while also independently carrying out responsibilities
• Extremely detail oriented with excellent project management skills and proficiency with Microsoft Office applications (e.g., Word, Excel, PowerPoint)
• Effectively manage stressful situations, multiple projects simultaneously and tight project
• milestone

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​

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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. ​

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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.

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