Senior Director Center of Excellence Signal Detection Head

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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