Associate Director, Postmarketing PV Case Management
5 days ago
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.
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.
- 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.
- 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 and training materials for AE, PC, and/or SRS collection.
- Inspection and Audit Management: Act as the point of contact for inspections and audits.
- 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.
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, including data entry, QC, medical review, and regulatory submissions.
Preferred Qualifications:
- Master’s degree in chemistry, biology, or a related field.
- 5+ years of experience in vendor management and oversight.
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.
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities.
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