Sr. Director, ICSR
The Senior Director will have high visibility across R&D and reports directly to the Vice President of Global Patient Safety. He/she is responsible for managing the line function at a technical and strategic level. The Senior Director will play a major role in shaping cohesive pharmacovigilance strategies through effective optimization and integration of all groups within their area of responsibility.
Responsibilities include the maintenance of structural organization within the Department, as well as the technical and managerial coordination of its groups and staff. Additionally, the Sr. Director will have full support from the other functions within Global Patient Safety as well the ability to work cross functionally with other areas in the organization
- Oversees development and implementation of standard processes and procedures in handling individual case safety reports and assuring compliance with global and local regulatory requirements
- Strategic and tactical clinical trial support to enable compliance in safety reporting in clinical trials
- Collaborates with GPS Quality, Standards & Training in identification and remediation in continuous improvement activities
- Collaborates with the Operations group to ensure quality inputs and outputs of the safety database
- Collaborates with the Sr. Director of Medical Operations to ensure consistent standards and quality of ICSRs
- Serve as functional lead in collaboration with key internal and external stakeholders
- Effective management of resources, vendors, business partners, and CROs
- Manages personnel performance and develops career growth opportunities across the department
- Provides expert guidance and leadership, internally and externally
- Responsible in maintaining quality, standards and training of personnel
- Responsible in ensuring the most effective utilization of the safety database to support safety reporting, audits and inspections
- Anticipates regulatory changes and develops contingency plans accordingly
- Represents GPS function on Vertex Corporate teams
- Bachelor degree in life sciences or allied health fields required; 5+ years of direct Pharmacovigilance experience
- Solid knowledge of safety database operations and function
- Strong knowledge of Global Regulations, standards and best practices regarding safety processing and reporting, safety surveillance and pharmaceutical industry compliance activities in pre-marketing and post-marketing
- Strong operational skills as demonstrated by leading previous projects or functions and or equivalent in training and education in areas such as lean sigma or MBA
- Experience as a line manager or people manager
- M.D. or Masters /Doctorate level in life sciences or allied health fields, 5+ years of direct Pharmacovigilance experience
- Excellent verbal and written communication skills.
- Self-starter with proven ability to thrive in a fast-paced environment handling multiple simultaneous high priority tasks
- Successful track record of developing and mentoring staff
- Maintains high ethical standards, including a commitment to Vertex's values and behaviors
Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis and other life-threatening diseases. Founded more than 20 years ago in Cambridge, Mass., we now have ongoing worldwide research programs and sites in the United States, United Kingdom and Canada. Vertex has consistently been recognized as one of the industry's top workplaces by leading publications such as Science magazine, The Boston Globe, Boston Business Journal, San Diego Business Journal and The Scientist.
For more information and to view Vertex's press releases, please visit www.vrtx.com.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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