Risk Management Lead, Global Drug Safety Boston United States,
The main accountability of this role is to ensure adequate, efficient and compliant implementation and execution of RMP and post-marketing study commitment for Alexion’s products globally, in accordance with Alexion’s policies and procedures and local pharmacovigilance and international (GVP) requirements. This position is to develop, drive, support and monitor all activities and plans associated with Alexion’s product’s Risk Management Plans (RMPs) and post-marketing commitments globally, in close collaboration with the Safety Therapeutic area leads, the EU QPPV and the regional Risk Management Managers.
Job Duties & Responsibilities
Responsibilities for this role include, but are not limited to:
Business Process Owner:
Acts as Business Process Owner (BPO) of the Risk Management Process in Alexion Pharmaceuticals (or reports to the BPO)
Manage/oversee adequate implementation of the Risk Minimization activities globally
Track and manage local implementation plans and execution for all Risk Minimization Activities Globally
Ensure adequate training on RMPs and implementation plans for all stakeholders
Supports as process expert the development of additional PV activities and additional risk minimization measures in collaboration with the Therapeutic areas
Responsible for the development, and implementation of risk management activities for the Alexion product portfolio, including the implementation of Risk Management Plans (RMPs), Risk Minimization Actions, and risk management mandated additional risk minimization measures globally
Provide support and assistance to TA leads and regional Risk Managers in the coordination of Alexion responses to Health Authority questions on RMPs under evaluation.
Manage (dotted line) Regional RM/REMS specialist, i.e. US REMS specialist, Asia/Australia RM specialist, Japan RM specialist, EMEA/LATAM
Liaise with Therapeutic Area Heads and EU QPPV
Communicate and coordinate between all Global and local stakeholders with respect to Risk Management Plans
Interface with other Alexion functional groups such as Regulatory Affairs, Clinical Development, Medical Affairs, Quality, business units, as needed
Coordinate the local and global review and approval process for newly developed or updated country-specific RMPs (outside of the EU RMP) for Health Authority submission.
Organize and document periodic RMP governance meetings
Procedural and other Official Documentation
Own, create, maintain/streamline RMP procedural documents such as SOPs and Working Practice Documents including:
- Development and Maintenance of a Development and Core Risk Management Plan
- Submission to Competent Authorities and Distribution of Educational Materials to Healthcare Professionals and Patients
- EU Risk Management Plan
- Risk Management Implementation Procedure
- Orbit system Guide
- Various Templates
Business owner for Orbit RMP Tracking System:
Act as primary Alexion point of contact for Huron and business liaison with Feith
Work with Huron to implement Orbit upgrades and system enhancements
Ensure ongoing training program for Super Users and End Users
Ensure regular Quality Check of Orbit is performed
- Bachelor’s degree in a biologic/medical/clinical/nursing field
- At least 10 years experience in pharmaceutical industry in drug safety/pharmacovigilance
- Experience with Risk Management and Risk Minimization
- Knowledge of US and Ex-US pharmacovigilance risk management regulations
- Excellent communication and interpersonal skills
- Excellent project management skills
- Highly organized personality
- Scientific/clinical knowledge
- Ability to work with interdisciplinary, multicultural and matrixed teams
- Ability to travel internationally up to 25%
- Advanced degree desired
- Experience preparing and/or implementing Risk Minimization plans in a global setting
- Experience with clinical development or medical affairs is a plus
Boston, MA, United States
Some opportunities happen only once in a lifetime – like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes list of the World’s Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts’ Innovation District. The company also has offices around the globe and serves patients in more than 50 countries.
Alexion’s aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team. Further information about Alexion can be found at: www.alexion.com.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.
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