Clinical Safety Manager Job Description

Posted today

Clinical Safety Manager

AbbVie - Chicago, IL

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 [redacted] on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Job Description

This position 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. This role provides strategic and tactical support for the function to ensure the CTPS team has the appropriate training, procedures and technologies to deliver on our commitments. They will assist with operational oversight to provide leadership the data needed to lead the department.

Responsibilities:

Supports/creates CTPS training/onboarding programs, ongoing knowledge attainment, and technical development of staff by effectively identifying department needs.
Identifies, collects, collates and communication operational metrics to CTPS leadership to ensure informed management decisions.
Creates and sustains an environment that attracts, develops, and retains talented scientific professionals.
Assists management with strategic planning and department development. Develop and participate in special projects for respective teams or CTPS initiatives.
Applies advanced knowledge of ICH, FDA, EMA regulations and guidelines affecting drug safety issues to assigned responsibilities as they impact on CTPS processes, procedures, technology solutions and global reporting requirements.
Understands, implements and improves department SOPs as part of continuous improvement, including implementation of new regulatory requirements.
Develops, maintains, and improves training materials working with process owners/SMEs/mentors.
Supports CTPS business operations, including but not limited to meeting and project planning, communication planning/alignment and ad hoc project support including project management.
Maintains expertise in CSA processes in order to serve as SME.
Coordinate quality assurance activities supports CTPS in the SMORES process.
Lead development and implementation of processes to align with new FDA or other regulatory agency guidelines.
Identify areas of improvement in process/policy, develops recommendations/plan and align/maintain effective communication channels with key Clinical, Medical, Regulatory, Compliance, and Pharmacovigilance counterparts.
Reviews SDEA agreements for CTPS to ensure/facilitates compliance to the agreement for clinical safety data.
Acts as a technology SME for CTPS/PPS for clinical safety data and influences analytical technology delivery by representing functional strategic needs
Enables data driven insights to support the evaluation of the safety profile for development products.

Qualifications

Qualifications:

Bachelor's degree with related health science background. RN or clinical pharmacy experience strongly preferred.
A minimum of 6 years' experience to include at least 3 years of clinical practice experience and 2 years drug safety experience with clinical trial life cycle management - Pre-clinical to Phase III through launch to market.
Proficiency in Computer skills (Windows, Word, Excel) and in specific databases (e.g., oracle/clinical, PIMS, laboratory databases) or data visualization technologies.
Ability to lead cross-functional teams with proven success in results-driven process management.
Expertise in industry regulations, processes, and clinical safety.
Demonstrate excellent interpersonal, leadership, communication and development skills.
Ability to establish clear directions/ sets stretching objectives. In depth understanding of product labeling/literature, including safety profile.
Accurately and medically sound presentation of case data, orally and in writing. Strong interpersonal and influencing skills.
Ability to manage complex issues and distill information with proven negotiating skills.

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.

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.