Associate Director, Postmarketing PV Case Management

United Therapeutics Associate Director, Postmarketing PV Case Management Baton Rouge, Louisiana The job details are as follows:

What We Do
We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun.
Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases.
Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC).
Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs.
At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.

Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition.
She sought to find treatment options and a cure for her daughter and patients like her.
We are founder-led, and relentless in our pursuit of 'medicines for life'.
We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases.

How you'll contribute
The Associate Global PV Case Management Director plays a key role in management and oversight of end-to-end case safety management activities spanning across our global commercial product portfolio.
This position strategizes and implements plans to ensure compliance with global regulations and guidelines with regards to safety data collection, management and reporting for postmarketing ICSRs for efficiency, quality, and compliance impacts.
This role is critical in ensuring that commercial operational aspects of pharmacovigilance activities are managed with rigorous global standards in proper documentation, evaluation processes, and decisions to support the overall global safety surveillance program and proper management of benefit/risk of UTC products.
This position can be remote in the continental US, or in our RTP, NC office and will include about 15% international and domestic travel.

Responsibilities include:

Process Evaluation and Strategy:
Evaluate, strategize, and execute process changes in response to regulatory updates.

Operational Oversight and Quality Assurance:
Oversee day-to-day quality and compliance for vendor staff supporting adverse effect processing.

Regulatory Compliance and Guidance:
Provide strategic guidance to ensure compliance with global regulations and guidelines.

Stakeholder and Vendor Management:
Act as the main point of contact for day-to-day questions or issue escalation.

Training and Development:
Develop, facilitate, and provide training materials for AE, PC, and/or SRS collection.

Inspection and Audit Management:
Act as the point of contact for inspections and audits related to end-to-end case processing activities.

SOP and Procedural Document Management:
Initiate and lead the development and implementation of new or revised SOPs.

Reconciliation and Compliance Oversight:
Oversee and resolve the PM reconciliation process.

Perform other duties as assigned.

For this role you will need:

Bachelor's degree in nursing, chemistry, biology, or a related field.

12+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs with a bachelor's degree, or 10+ years with a master's degree, or 7+ years with a PhD/PharmD/MD/DO/or international equivalent.

Previous experience using safety databases, preferably Argus.

Strong written and verbal communication skills.

End-to-end case processing experience.

Project management skills.

Working knowledge of drug development processes.

Strong analytical thinking skills.

Ability to work effectively across functions.

Ability to be adaptable in ambiguous situations.

Working knowledge of MedDRA coding.

Working knowledge of global regulations and guidelines.

Preferred Qualifications:

Master's degree or PhD in chemistry, biology, or a related field.

5+ years of experience in vendor management and oversight.

3+ years of product development and/or postmarketing drug experience.

2+ years of previous functional lead/people management experience.

Salary and Benefits:

The salary for this position ranges from $163,000 to $185,000 per year.
In addition, this role is eligible for the Company's short-term and long-term incentive programs.
Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more.

At United Therapeutics, you'll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged.
all while making a difference in the lives of our patients.

United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities.
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