Manager, Pharmacovigilance Support Operations - job 1 of 2

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.

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:

o Associate degree or Bachelor’s degree required.

Required experience:
o 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.
o Demonstrates strong interpersonal skills and the ability to work in a team-oriented environment.
o Excellent organizational skills, attention to detail and strong oral and written communication skills, drug safety or related experience.

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

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 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