Manager, Pharmacovigilance Support Operations

Allergan; North Chicago (IL); Remote; USD 75,000 - 95,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Supervisor for Support Operations in North Chicago. This role involves overseeing a team, ensuring compliance with policies, and acting as a subject matter expert. Candidates should have significant experience in case management and supervisory roles, alongside strong organizational and interpersonal skills. This position can be remote within the United States.

Benefits

Comprehensive medical/dental/vision insurance

Paid time off (vacation, holidays, sick)

401(k) to eligible employees

Short-term and long-term incentive programs

Qualifications

• 4-5 years of experience in an SOA role, 2 years in a supervisory role.
• Experience with GCM Clinical Case Management.
• Knowledge of ICH/FDA regulations.

Responsibilities

• Serve as primary contact for Support Operations activities.
• Supervise day-to-day operations of Support Operations Associates.
• Ensure compliance with Corporate and Divisional Policies.

Skills

Interpersonal skills

Organizational skills

Oral and written communication skills

Attention to detail

Critical thinking

Education

Associate degree or Bachelor’s degree

Job description

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 X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

Purpose

Serves as a primary point of contact and escalation of Support Operations activities. Acts as a Subject Matter Expert providing leadership, support and supervision for Support Operations areas within GCM Clinical Case Management. This supervisory/management position ensures that the day-to-day operations of Support Operations Associate (SOA) personnel within Data Entry, Clerical, Document Specialists, clinical case initiation, and Reconciliation areas are performed accurately and efficiently in accordance with established compliance timelines. Responsible for direct coordination of workflow of support staff personnel, direct precepting, training and documentation of new hires and contract personnel to all aspects of Support Operations function. Ensures team consistently implements all applicable processes. Responsible for the overall tracking and maintenance of workflow management systems and metrics and quality.

Responsibilities

Core job requirements include:

• Assess impact of issues on Support Operations and implements remedies or escalates appropriately with recommended resolutions.
• Assists with implementing strategy for the Support Operations area by translating business strategies/changing business conditions into clear objectives and tactics/contingency plan making the strategies clear to others.
• Responsible for compliance with applicable Corporate and Divisional Policies and Procedures while providing leadership and Support to Support Operations team.
• Ensures that the day-to-day operations of SOA Case initiation, Data Entry, Clerical, Document Specialist and Reconciliation SOAs are performed accurately and efficiently in accordance with established compliance timelines.
• Responsible for direct coordination of workflow, precepting, training and documentation of new hires and contract personnel to all aspects of Support Operations function.
• Responsible for regular updates for cross-functional team and stakeholders on assigned projects.
• Builds Support Operation team through development of employees and maintaining collaboration with departmental stakeholders.
• Ensures audit and inspection readiness and supports audits as necessary.
• Participates in the hiring process and develops direct reports by identifying short and long-term goals for their personal growth; develops direct reports by incorporating a cross-training program.
• Performs administrative tasks such as workload scheduling, timecard approvals, attendance monitoring and counselling, goal implementation and reviews, vacation request scheduling and overtime scheduling.
• Monitors and evaluates personnel performance against expectations, providing performance feedback in performing annual job performance appraisals.

This role can be remote within the United States.

Qualifications

Associate degree or Bachelor’s degree required.

Required experience:

• 4-5 years of experience in an SOA role, e.g. case initiation, data entry, clerical or document specialist role in GCM Clinical Case Management 2 years should be in a supervisory or management role with demonstration of successful coaching, mentoring and leadership.
• Demonstrates strong interpersonal skills and the ability to work in a team-oriented environment.
• Excellent organizational skills, attention to detail and strong oral and written communication skills, drug safety or related experience.

Preferred experience:

• 1-2 years of previous supervisory and/or team lead experience strongly preferred.
• 2 years of demonstrated experience leading teams and multi-disciplinary projects.
• Knowledge of ICH/FDA regulations, guidelines affecting Drug Safety reporting.
• Demonstrates understanding of adverse event reporting process and product safety function including its impact internal and external to the department.
• Knowledge of medical terminology.
• Strong critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making.
• Excellent interpersonal skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements, resourcefulness and creativity.

Additional Information

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

• This job is eligible to participate in our short-term incentiveprograms.

• This job is eligible to participate in our long-term incentiveprograms

Note: No amount of payis considered to bawages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Company’s sole and absolute discretion, consistent withapplicable 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