The Pharmacovigilance Project Manager/Sr. Pharmacovigilance Project Manager (PVPM) works in a regulated environment and is responsible for coordinating and driving activities relative to the Safety Evaluation and Risk Management (SERM) team. This individual manages processes and people through matrix reporting, and serves an essential role in facilitating cross-functional efforts within the department, the Company, and co-development partners. The role requires active involvement to meet timelines and to recognize and resolve problems or conflicts. It also entails collegial interaction with functional peer groups at various management levels. Gaining SERM team and cross-functional cooperation, managing timelines, creating and delivering presentations of technical information, communicating diplomatically, and solving problems are keys to success.
Acting as operational nexus for inter- and intra-departmental groups to coordinate, organize, track, and complete activities in support of signal detection and risk management
Exercising independent judgment with little input from management in developing methods, techniques, and evaluation criteria for obtaining results
Applying project management expertise, methodologies, and department standards to be strategic in planning and implementation
Using strong project and organizational knowledge, conduct/facilitate SERM meetings and managing activities via agendas, minutes, trackers, timelines, etc.
Informing all team members and groups of deliverables and timeline, project developments and insuring completion according to timelines
Working effectively and closely in a matrix environment with on- and off-site team members to integrate input into operational plans
Tracking the progress of activities with trouble-shooting of any emerging problems
Identifying critical path issues and alternative plan scenarios
Recognizing, negotiating, and managing competing priorities.
Adhering to Drug Safety SERM or SERM project specific quality documents (e.g. SOPs, work practices, training guides), as applicable
Contributing to the functional excellence of the department by participation in the development and continuous improvement of processes, procedures, and tools related to Drug Safety and SERM practices
Communicating effectively with team members, senior leaders, and the broader organization
Providing support for coordination and management of the development of periodic safety/regulatory reports according to timelines and regulations
Managing complex and time-sensitive special projects, such as ad hoc Regulatory Authority safety queries
Ensuring timely receipt and accurate archiving of documents in support of inspection-readiness
Interfacing with corporate/co-development partners
Requires BS/MS in life sciences
Minimum of 2 years in a pharmaceutical or biotechnology environment with at least 2 years in a project management function
Demonstrated highly effective organizational and communication skills
Knowledge of CFR and GCP/ICH requirements is required, as well as European Clinical Trial Directive knowledge is preferred
Demonstrated leadership skills and the ability to solve problems proactively
Proficiency with Excel, MS Project, MS PowerPoint, and vendor oversight
Demonstrated ability to independently plan, identify risks, anticipate issues and outcomes and respond strategically, tactically and operationally while balancing short-term and long-term objectives of the Company
Project Management Certification (PMP) is a plus
As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.
Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.
Internal Number: 2018-257
About Seattle Genetics
Revolutionary science meets transformative cancer therapy.
Seattle Genetics is the largest global oncology biotechnology company based in the Pacific Northwest. We are focused on developing and commercializing a new generation of targeted, empowered antibody-based therapies that have the potential to change the foundation of treatment for people with cancer.