Clinical Safety Manager (Remote)

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

The Clinical Safety Manager supports the Clinical Trial Patient Safety (CTPS) organization to achieve its mission of evaluating and ensuring the quality of clinical trial patient safety data by consistent and accurate delivery of high-quality, relevant, and timely data review. Contributes to and creates a culture of process improvement, employee development, performance measures, project prioritization, and to develop/implement successful
solutions leading the CTPS team, translating the business vision into broad and actionable strategies.

This position is responsible for world-wide surveillance of clinical trial patient safety data, including organization, resourcing, and continuous improvement efforts. Supports Associate Director of CTPS.

Responsibilities:

This position is responsible for world-wide surveillance of clinical trial patient safety data, including organization, resourcing and continuous improvement efforts. Supports Director of CTPS.

• Provides timely assessment of reported clinical trial data and participates in applicable safety surveillance activities for assigned studies including review and contribution to ad-hoc Safety Reports as needed.
• Provide independent review and analysis of safety-related data from clinical trials for content, quality, potential signal identification, and adherence to regulatory guidance and protocols utilizing critical thinking skills.
• Understands and implements department SOPs as part of continuous improvement, including implementation of new regulatory requirements.
• Manages 3 to 8 people in assigned compound associated with clinical studies and related systems to ensure clinical safety adverse event surveillance is managed in a compliant and timely manner meeting quality outputs within an inspection-ready environment.
• Monitor, evaluate, and communicate workload and metrics for operational area(s).
• Supports department training programs, ongoing knowledge attainment, and development of staff.
• Participates in talent management processes.
• Develop and participate in special projects for respective teams or CTPS initiatives.
• Partner with therapeutic area MDs/medical monitors to plan/execute or provide oversight of medical safety review at the study level, including ad-hoc safety reports, IRB/IEC safety issues, narratives, safety review plans etc.
• Provide oversight of narrative deliverables, issue management, document management systems, and centralized data review for assigned compound associated clinical studies. Effectively communicates/escalates relevant study and/or team-related information to appropriate clinical team members and/or management.
• Aligns and maintains effective communication channels with key clinical, medical, study team, including regulatory, compliance, and pharmacovigilance counterparts.

Qualifications

Minimum Qualifications:

• Bachelor's degree with related health science background is required
• 6+ years experience
• 3+ years of clinical practice experience (i.e. bedside clinical experience)
• 2+ years drug safety experience with clinical trial life cycle management - Pre-clinical to Phase III through launch to market.

Preferred Qualifications:

• RN or clinical pharmacy experience strongly preferred.
• Demonstrated experience in direct people management preferred.

Other Required Skills:

• Aligns Abbvie principles and values to all areas of work.
• Computer proficient (Windows, Word, Excel) and proficient in use of databases (e.g., oracle/clinical, EDC, laboratory databases).
• Demonstrates ability to establish clear directions, sets stretch objectives.
• Demonstrates excellent interpersonal, leadership, communication and development skills. Able to give and receive constructive feedback
• Strong influencing skills. Ability to manage complex issues and distill information.

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.

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

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