Website Apolis
Apolis
Company : Apolis
Senior Scientist
Remote (EST hours)
6+ months contract
Pay range:- $120-170/Hour on W2
About the role:
Are you looking for a patient-focused, innovative-driven company that will inspire you and empower you
to shine? Join us as a PV Director/Associate Director of PV Risk Management. At ***, we are
transforming the pharmaceutical industry through our R&D-driven market leadership and being a value-
led company. To do this, we empower our people to realize their potential through life-changing work.
Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for
excellence in everything we do.
As an Director/Associate Director of PV Risk Management, being part of our Risk Management and
Benefit risk center of excellence, you will be empowered to work cross-functionally with colleagues to
establish and manage the processes for Risk Management, benefit risk, RMPs, additional Risk
Minimization Measures and REMS programs and Benefit Risk deliverables.
How you will contribute:
• 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.
Minimum Requirements/Qualifications:
• 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
• Pharmaceutical industry experience, with exposure to PV risk management, additional risk
minimization measures and/or REMS programs preferred
• Strong track record of scientific and analytical thinking
• Experience presenting to technical and Client groups at public meetings is desirable
• 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
What *** can offer you:
• Comprehensive Healthcare: Medical, Dental, and Vision
• Financial Planning & Stability: 401(k) with company match and Annual Retirement
Contribution Plan
• Health & Wellness programs including onsite flu shots and health screenings
• Generous time off for vacation and the option to purchase additional vacation days
• Community Outreach Programs and company match of charitable contributions
• Family Planning Support
• Flexible Work Paths
• Tuition reimbursementv