| Job Description | Description
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.
Center of Excellence Signal Detection Head
Job Responsibilities/Department description:
We have a key position in our Global Patient Safety Organization for a Center of Excellence Signal Detection Head (CoE SD Head). The CoE SD Head is responsible for implementation and maintenance of the GPE signal detection (SD) and data mining (DM) processes, guidelines and harmonization across product areas. S/he defines required standards and functions as the accountable senior management representative.
Responsibilities will include:
Management:
Functional management of SD and DM personnel
Prioritization and resource allocation of SD and DM support
Oversees periodic SD and DM activities within SSRM product areas of Sanofi products
Ensure that the SD and DM objectives are achieved and compliance goals are met
Ensure alignment of CoE SD objectives, metrics and issue escalation with SSRM Area
Leaders and SSRM head
Develop and progress processes to ensure state-of-the-art pharmacovigilance
Contributions
Internal and external safety Expertise:
Set medical, scientific and SD and DM standards for all SSRM product areas
Provides SD expertise within the Company as the SSRM senior representative
Maintains expertise in SD and DM and ensures implementation of state-of-the-art and
innovative SD techniques
Communication
Interface with SSRM product areas, CoE RM, Epidemiology, PV operations and PV Quality,
Training and Compliance (QTC)
Senior contact for all SD related matters to cross-functional groups, external companies
and authorities
Ensures appropriate recognition of signals for assessment
Team development
Supervise, mentor and develop SD and DM personnel (physicians, scientists) within CoE
SD
Ensure training and technical ability across SSRM product areas
Lead regular team meetings to further transparency on strategic decisions, goals and
objectives. Schedule frequent peer review sessions to foster improvement of critical
reasoning and debating skills
Ensure training of all SSRM product area staff in SD and DM expertise (PV scientists)
Budget Management:
Defines Budget planning for CoE SD consistent with the guidelines provided by SSRM
Head
Ensure the CoE SD stays within defined expense goals
Qualifications
Basic Qualifications:
Advanced medical degree (MD, PhD, PharmD)
Minimum of 8 years total experience in pharmacovigilance and/or relevant medical field or
equivalent, including a minimum 5 years of international pharmacovigilance activities
Expertise in pre and post marketing SD
Expertise in DM of large data bases
Excellent medical interpretation skills of case safety reports and aggregate data
Experience in medical interpretation of clinical cases and aggregate data
Minimum 5 years supervisory/ management experience in matrix organization with proven proficiency in organizational and planning capabilities
Preferred Qualifications:
M.D. Degree
Demonstrated leadership ability in the pharmaceutical industry with proven ability to succeed in multidisciplinary teams; proven ability to motivate, problem-solve, prioritize, take initiative,and meet challenges
Excellent clinical judgment
Significant practical clinical experience relevant to safety SD and DM
Capability to synthesize and critically analyze data from multiple sources
Ability to communicate complex clinical issues and analysis orally and in writing
Able to develop and document sound risk assessment
Demonstrates initiative and capacity to work under pressure
Demonstrates leadership within cross-functional team environment
Excellent teamwork and interpersonal skills
Experience in medical pharmacovigilance function (e.g. PV physician or PV scientist)
Experience in transactional pharmacovigilance functions |
| | Company | | Genzyme | Job Code | | State or Province | | Massachusetts | | |
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