Top 3 Must Have Skill Sets:
hard skills (3 years of experience)
Risk Management experience
Drug development/clinical experience (science-based)
Conducts safety risk management processes and activities. Ensures that safety risk management (RM) processes are continuously improved to reflect regulatory trends and guidelines and represent best in class. Establishes and maintains our corporate safety risk management processes, roles and responsibilities. Leads negotiations with partner functions (e.g. Development and Clinical, Regulatory, Biostats, Commercial, Business Partners) to achieve the most effective integration of all available skills, tools, and data into safety risk management processes to ensure the most accurate benefit/risk profile throughout the product lifecycle and to maximize patient safety. Provides centralized support, training for Safety and corporate members who work on RM plans and communications.
Provides guidance for risk management across our product portfolios and provides aid to Safety Staff as they develop risk management plans
Provide input for the development and updates of respective standards, guides and templates related to benefit-risk management.
Provide expertise and support to ensure consistency across our products in approach to risk management globally
Ensure we adheres to and is aligned with Global Health Authority regulations regarding risk management practices
Contributes to cross-functional initiatives aimed to improve pharmacovigilance capabilities related to benefit risk management
Monitors risk management metrics and reports to assure we is in compliance with global benefit/ risk management standards
Supports inspection and audit activities with regards to the RM processes within Safety, be representative and point of contact for Health Authority Inspection and
Internal Process Audits within the remit of role and responsibility
Assist in creations of EU-RMP, REMS, country specific RMPs. Assist in creation of Risk management specific questions from regulatory agencies.
Supports development of risk management plans in modular format and cross-use and reference of modules in PBRER etc.
Provides support to benefit risk implementation process and training
Represents the activities of safety risk management process planning in internal and external meetings
Identify best strategies for risk mitigation and measurement of effectiveness of risk minimization measures.
Participates in the development of recommendations in the process of risk identification, regarding mitigation measures, necessary compliance system improvements, and risk communication
Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor
Knowledge and Skills
Demonstrated knowledge of global aspects of drug safety
Familiarity with industry principles of drug development and pharmacology, biostatistics, clinical trial methodology, and pharmacoepidemiology
Strong knowledge of global safety reporting activities, regulations, and guidelines
Excellent verbal and written communication skills, including formal presentation skills
Broad organizational knowledge, independence, networking and influencing skills, as well as managerial experience to deal with potential conflicts of interest among various stakeholder groups
Proven written skills
Strong leadership skills and extensive experience in leading teams in a matrix environment
Relevant knowledge of Pharmaceutical Company organizational structure, policies, and practices, as applicable to Safety and Risk Management
Knowledge of Risk Management regulations and drug development process
Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization at various levels
Demonstrated success in navigating a highly matrix-based organization to deliver against complex program plans.
Working effectively when co-located with, AND when remote from, product teams/leaders/managers. Demonstrated ability to handle more than one complex project simultaneously
Education & Experience (Basic)
Doctorate degree and 2 years of Pharmacovigilance experience OR Master’s degree and 6 years of Pharmacovigilance experience OR Bachelor’s degree and 8 years of Pharmacovigilance experience OR Associate’s degree and 10 years of Pharmacovigilance experience OR High school diploma / GED and 12 years of Pharmacovigilance experience
Education & Experience (Preferred)
B.S., M.S. in health science with significant advanced training. Knowledge of medical, clinical or pharmacovigilance is required.
Minimum 10 years of pharmaceutical/industry experience with 3 years in global drug safety and risk management. Familiarity with management of performance metrics is desirable.
Experience across multiple therapeutic areas
"This posting is for Contingent Worker, not an FTE"