Associate Medical Director

BioSpace; North Chicago (IL); Presencial; USD 150.000 - 190.000; Jornada completa

Descripción de la vacante

AbbVie in North Chicago seeks a Medical Safety Review (MSR) lead to oversee clinical trial SAEs, perform causality assessments, and develop company analyses for SUSARs under therapeutic area leadership.

The role requires an MD or equivalent, strong regulatory knowledge, and the ability to guide cross-functional teams, communicate with trial stakeholders, and contribute to MSR training and audits.

Formación

• MD or equivalent is required.
• Proficiency in medical review of SAEs and regulatory expectations.

Responsabilidades

• Performs medical review of clinical SAEs.
• Develops Company Analysis for SUSARs.
• Leads therapeutic area initiatives and may supervise staff.
• Ensures timely communication with clinical trial stakeholders.
• Conducts causality assessment of adverse events in post-marketing reports.

Conocimientos

Medical safety review

Causality assessment

Leadership

Educación

MD or equivalent

Descripción del empleo

Company Description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Purpose

Job Description

The primary focus of this position is the Medical Safety Review (MSR) of clinical trial SAEs including causality assessment and company analysis development combined with therapeutic area leadership.

Responsibilities

• Contributes above the level of individual case review through leadership of individual project or initiative.
• Provides overall leadership to one therapeutic area in primary role; may also serve in secondary role for additional therapeutic area.
• May have people management responsibilities with one or more direct reports.
• Performs medical review of clinical SAEs.
• Develops Company Analysis for SUSARs.
• Responsible for accurate and timely communication with all clinical trial stakeholders.
• Performs causality assessment of adverse events in post-marketing individual case safety reports.
• Understands safety profile of assigned AbbVie products and development compounds as well

safety aspects of relevant therapeutic area drugs and patient populations. '

• Understands disease state for each indication within assigned AbbVie products and development compounds.
• Understands global regulations, processes and practices.
• Contributes as requested to PPS initiatives, controlled procedures and MSR training activities; supports audits, inspections and CAPA investigations as necessary.

Qualifications

• MD or equivalent

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 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