Director, Patient Safety & PV Oversight

United Therapeutics Corporation; Morrisville (NC); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Medical coverage

Paid time off

401k savings plan

Employee wellness resources

Job summary

United Therapeutics Corporation is seeking an Associate Patient Support Program Safety & PV Oversight Director in Morrisville, NC. This full-time role is integral in managing safety data exchanged by Patient Support Programs. Responsibilities include ensuring regulatory compliance, overseeing quality standards, and leading strategic discussions to improve processes. Candidates must have extensive pharmacovigilance experience and a relevant degree. Competitive benefits package included.

Qualifications

• 12+ years of experience in pharmacovigilance of ICSRs with Bachelor's Degree.
• 5+ years of experience in management and oversight of a call center.
• Strong knowledge of GvP regulation and QMS documentation requirements.

Responsibilities

• Provide oversight of safety data for compliance and quality.
• Manage adverse effect reporting and ensure documentation standards.
• Act as point of contact for audits related to data exchange.

Skills

Pharmacovigilance expertise

Management experience

Strong communication skills

Microsoft Office Suite proficiency

Problem-solving ability

Education

Bachelor’s Degree in health care or life sciences

Master’s Degree in health care or life sciences

Doctor of Pharmacy (PharmD)

Tools

Safety databases (Argus)

Job description

United Therapeutics Corporation is seeking an Associate Patient Support Program Safety & PV Oversight Director in Morrisville, NC. This full-time role is integral in managing safety data exchanged by Patient Support Programs. Responsibilities include ensuring regulatory compliance, overseeing quality standards, and leading strategic discussions to improve processes. Candidates must have extensive pharmacovigilance experience and a relevant degree. Competitive benefits package included.