: Global Safety Risk Management Scientist (JP8151)
Thousand Oaks, CA
: 6 months with likely extensions
Job posting date
Remote until COVID-19 restrictions are lifted.
3 Key Consulting is hiring a Global Safety Risk Management Scientist for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
- Conducts the client 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 the client 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.
Knowledge and Skills
- Provides guidance for risk management across the client 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 the client’s products in approach to risk management globally.
- Ensure that the client 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 the client 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.
Education & Experience (Basic)
- 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 stakeholders 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 (Preferred)
- 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.
Top Must have Skill Sets:
- 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.
Hard skills (3 years of experience):
Risk Management experience
Drug development/clinical experience (science-based)
Employee Value Proposition:
Evolving field of work, exposure to a new group within a biotech/pharma company, growing their skill set
No Drug development/clinical experience (science-based) - MUST HAVE FOR THIS ROLE
We invite qualified candidates to send your resume to email@example.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com
. You are welcome to also share this posting with anyone you think might be interested in applying for this role.