United Therapeutics Corporation · 9 hours ago
Associate Director, Postmarketing PV Case Management
North Carolina, United States
Full-time
Remote
Senior Level, Lead/Staff
$163K/yr - $185K/yr
12+ years exp
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Responsibilities
Evaluate, strategize, and execute process changes in response to regulatory updates, ensuring the effectiveness and efficiency of end-to-end commercial case processing; Initiate, plan, coordinate, and implement project plans to enhance process efficiencies and support business goals and objectives; Strategize and implement functional and department goals for the PM case processing operations team
Oversee day-to-day quality and compliance for vendor staff supporting adverse effect processing for commercial UT products, including PM GSD workflows; Maintain unified PM Case Management operating procedures and monitor systems to ensure all PM adverse effects are processed and submitted per UT SOPs and industry standards; Evaluate and sign off on all SOPs related to postmarketing case management activities
Provide strategic guidance to ensures compliance with global regulations and guidelines for safety data collection, management, and reporting of postmarketing ICSRs; Remain current on global regulations, guidelines and industry best practices for end-to-end case management, ensuring compliance with global regulations and guidelines and timely processing of individual case reports
Act as the main point of contact and functional manager for day-to-day questions or issue escalation regarding PM case handling safety processes for internal stakeholders (i.e. PSRMMT, quality, regulatory), vendors, and external partners; Participate in strategic discussions with vendors and other team members of GPS & PV to ensure process compliance
Develop, facilitate, and provide training and training materials for AE, PC, and/or SRS collection and reporting of adverse effects in the commercial setting, in accordance with SOPs, global regulations, guidelines, and conventions; Direct and manage direct reports to include responsibilities for training, goal setting & achievement, performance evaluations/management, coaching, mentoring, career development and provide support for recruitment process (as needed)
Act as the point of contact for inspections and audits related to end-to-end case processing activities for PM case types; Conduct root cause analysis of inspection or audit findings and ensure appropriate CAPA is in place to address the findings; Review and approve deviations/CAPAs for any PM ICSR-related activity as necessary
Initiate and lead the development and implementation of new or revised SOPs; Update and maintain procedural documents to reflect current practice related to GPS/PV Operations
Oversee and resolve the PM reconciliation process, ensuring all discrepancies are addressed and compliance is maintained
Perform other duties as assigned
Qualification
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Required
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 of experience in pharmacovigilance in end-to-end case processing of ICSRs with a master's degree or
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, including but not limited to the ability to communicate safety issues in a variety of formats required to meet the needs of the intended audience and contributors
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, including but not limited to having the ability to explain the legislative framework supporting all aspects of drug development & registration of medicines, ensuring their safety
Strong analytical thinking to diagnose common situations, gather and review relevant information, and recommend solutions
Ability to work effectively across functions; understands objectives, activities, and required contributions of internal partner functions
Ability to be adaptable and work effectively in ambiguous situations
Ability to challenge current state, suggest alternative approaches to improve work practices, and commit to defined changes
Working knowledge of MedDRA coding
Working knowledge of global regulations, guidelines and industry best practices for end-to-end case management for devices, biologics, and drug products
Preferred
Master’s degree in chemistry, biology, or a related field or
Doctor of Philosophy (PhD) in chemistry, biology, or a related field or
Doctor of Pharmacy (PharmD) or
MD or DO or international equivalent or
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 / vision / prescription coverage
Employee wellness resources
Savings plans (401k and ESPP)
Paid time off & paid parental leave benefits
Disability benefits
Company
United Therapeutics Corporation
United Therapeutics Corporation is a biotechnology company focused on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening conditions.
501-1000 employees
H1B Sponsorship
United Therapeutics Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (4)
2022 (4)
2021 (12)
2020 (3)
Funding
Current Stage
Public CompanyTotal Funding
unknown1999-06-17IPO
Leadership Team
Hamlet Bonilla Evertsz
Senior Network Engineer
Recent News
2024-12-05
GlobeNewswire News Room
2024-12-03
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