Company DescriptionAbbVie'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 DescriptionPurposeThis role partners closely with the Safety Review Board (SRB) Chair and is responsible for providing strategy, direction, and oversight to cross-functional safety governance leaders across AbbVie who are members of the SRB. The SRB is a critical component of AbbVie’s safety governance model, overseeing cross-functional activities impacting the benefit-risk profile of AbbVie products.Responsibilities
Lead the safety governance function across all AbbVie products, including marketed and pipeline assets, to ensure effective infrastructure for material information flow, compliance with safety governance reporting requirements, and issue escalation to the SRB.
Partner with SRB Chair on relevant company policy and proposed remediation. Execute on approved remediation with Legal consult as appropriate.
Partner with Protocol Safety Review Committee Chair in review of first-in-human clinical trial protocols for new molecular compounds and relevant protocols with administration of biologics to ensure safety provisions are adequately protecting clinical trial subjects, ensure compliance with safety governance requirements, and inform/escalate outcome to SRB as appropriate.
Advise Product Safety Teams (PSTs) and Asset Development Teams (ADTs) on safety governance deliverable requirements and expectations.
Lead and conduct lessons learned, propose recommendations, and execute on endorsed recommendations.
Support SRB-directed initiatives by identifying strategies and collaborating with stakeholders to ensure desired outcomes are met (e.g., Issue Management Team, FDA Advisory Committee, etc.).
Responsible for the integration and onboarding of relevant entities (e.g., subsidiaries, internal committees, consultants, etc.) into the safety governance framework, as required, to support oversight of patient safety.
Accountable for the ongoing revision and development of policies and procedures that ensure safety governance practices are within FDA and Regulatory guidance and compliance. Lead CIA compliance reporting consolidation and ensure continuous audit readiness.
Responsible for identifying and presenting key performance metrics to inform senior leaders on the overall health of safety governance compliance.
Business owner for safety governance systems and responsible for oversight and optimization of technology, automation, resource management, and reporting across multiple teams required to ensure compliance with safety governance requirements.
Significant Work ActivitiesFrequent to continuous computer usage (greater or equal to 50% of the workday) is requiredContinuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is requiredQualificationsQualifications
Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, or related life sciences; advanced degree is highly desirable.
Minimum 8 years pharma experience in Pharmacovigilance, R&D or related area; clinical/safety operations and regulatory compliance experience desirable.
Strong leadership ability with proven experience in situations of conflict resolution, problem solving and crisis management.
Strong business acumen; ability to think strategically, translate a strategy into an innovative plan and execute.
Excellent leadership, self-management and organizational skills.
Experience with government regulatory agency interaction, e.g., FDA Advisory Committee, MHRA inspection, and/or preparing presentations and providing written responses.
Experience leading cross-functional teams.
Excellent relationship management skills.
Strong verbal and written communication skills; medical writing experience desired.
Additional InformationApplicable 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.