LanceSoft, Inc. · 1 month ago
Associate Director of PV Risk Management
United States
Full-time
Remote
Lead/Staff, Director/Executive
$160/hr - $177.15/hr
4+ years expLanceSoft, Inc. is a patient-focused, innovative-driven company transforming the pharmaceutical industry through R&D-driven market leadership. The Associate Director of PV Risk Management will provide guidance on risk management strategies, collaborate with global functions to ensure patient safety, and develop risk management plans and assessments.
Information Technology
Responsibilities
Provides guidance and subject matter expertise on risk management and risk minimization strategy to an assigned therapeutic area to ensure that product risk management strategies are consistent worldwide
Provide guidance and subject matter expertise on the structured benefit risk assessment framework and the development of the benefit risk assessment document
Engages with partner global functions (e.g. Clinical Science, Med Affairs, Regulatory Affairs, Biostats) to ensure alignment of global position for pharmacovigilance risk management processes to maximize patient safety
Provide strategic expertise to cross-functional product team members in developing pharmacovigilance risk strategies including benchmarking and scenario planning
Support the development of risk management plans (RMPs) in modular format, review RMPs) and ensure alignment with Good Pharmacovigilance Practices and other applicable regulations
Develop and review risk minimization documents such as additional risk minimization measures (aRMMs) and Risk Evaluation and Mitigation Strategy (REMS)
Provide subject matter expertise and thoughtful contributions to qualitative and quantitative structured benefit risk assessments
Provide guidance on incorporation of the patient’s perspective into benefit risk activities (e.g. patient preference studies)
Collaborate with Safety Leads, Clinical Leads, PV scientists and Clinical Research Scientists, and others cross functional teams on benefit risk assessment strategy
Develop and provide recommendations for appropriate risk management interventions such as direct healthcare professional communications, educational materials, controlled access program
Provide guidance regarding tracking risk management commitments including utilization of a tracking platform and system improvement assessment
Monitor and report risk management metrics to ensure compliance
Provide centralized support, training and leadership for safety and cross-functional members who work on risk management plans and risk minimizations activities
Support inspections and audits activities with regards to risk management processes
Perform other duties as defined in standard operation procedures or requested by supervisor
Qualification
Required
Associate Director: PhD/PharmD/DO/MD + 4 years; OR Masters + 7 years; OR Bachelors + 10 years
Minimum 2 years in PV/safety OR clinical development preferred
Minimum 3 years of pharmaceutical industry/drug development experience
Strong track record of scientific and analytical thinking
Demonstrate integrity and work productively in a high-pressure environment
Good analytical/judgment capabilities to understand/analyze/synthesize and communicate
Project Management abilities
Ability to identify and understand proactively the interactions necessary for achieving business goals and objectives
Able to manage both time and priority constraints and to manage multiple priorities simultaneously
Attention to details, computer literacy, knowledge of safety databases
Take initiative and autonomous action
Proven ability to work in an international environment and with cross-functional teams, with good interpersonal skills / assertiveness / team spirit / coaching skills
Preferred
Minimum 2 years in PV/safety OR clinical development preferred
Pharmaceutical industry experience, with exposure to PV risk management, additional risk minimization measures and/or REMS programs preferred
Experience presenting to technical and Client groups at public meetings is desirable
Company
LanceSoft, Inc.
Established in 2000, LanceSoft is a pioneer in delivering top-notch Global Workforce Solutions and IT Services to a diverse clientele.
5001-10000 employees
H1B Sponsorship
LanceSoft, Inc. 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
2025 (55)
2024 (32)
2023 (23)
2022 (25)
2021 (60)
2020 (80)
Funding
Current Stage
Late StageLeadership Team
Ram Karuppusamy
Chairman & CEO
Simon Dealy
Chief Financial Officer
Company data provided by crunchbase