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About the position
The Associate Director, Postmarketing PV Case Management plays a crucial role in overseeing the end-to-end case safety management activities for United Therapeutics' global commercial product portfolio. This position is responsible for ensuring compliance with global regulations regarding safety data collection, management, and reporting for postmarketing Individual Case Safety Reports (ICSRs). The role involves strategic planning, operational oversight, quality assurance, and stakeholder management to support the pharmacovigilance activities and ensure the safety of UTC products.
Responsibilities
- Evaluate, strategize, and execute process changes in response to regulatory updates.
- Oversee day-to-day quality and compliance for vendor staff supporting adverse effect processing.
- Provide strategic guidance to ensure compliance with global regulations and guidelines for safety data collection.
- Act as the main point of contact for day-to-day questions or issue escalation regarding PM case handling safety processes.
- Develop, facilitate, and provide training and training materials for adverse effects collection and reporting.
- Act as the point of contact for inspections and audits related to end-to-end case processing activities.
- Initiate and lead the development and implementation of new or revised SOPs.
- Oversee and resolve the PM reconciliation process.
Requirements
- 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.
- 10+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs with a master's degree.
- 7+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs 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.
- Project management skills and ability to organize and deliver large, complex projects independently.
- Working knowledge of drug development processes and activities.
- Strong analytical thinking to diagnose common situations and recommend solutions.
- Ability to work effectively across functions and understand objectives of internal partner functions.
- Ability to be adaptable and work effectively in ambiguous situations.
- Working knowledge of MedDRA coding.
- Working knowledge of global regulations, guidelines and industry best practices for end-to-end case management.
Nice-to-haves
- Master's degree in chemistry, biology, or a related field.
- Doctor of Philosophy (PhD) in chemistry, biology, or a related field.
- Doctor of Pharmacy (PharmD) or MD or DO or international equivalent.
- 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.
- Prior PV management experience.
Benefits
- Medical, dental, and vision coverage
- Prescription coverage
- Employee wellness resources
- Savings plans (401k and ESPP)
- Paid time off
- Paid parental leave benefits
- Disability benefits
