Senior Director Global Patient Safety Sanofi Cambridge

Job description
The Senior Director Global Patient Safety/Pharmacovigilance, Global Safety (MD) is the safety expert and safety lead for Sanofi products. This position will provide support to Lemtrada.

Major Duties & Responsibilities

Internal & External Safety Expert
Provide PV and risk management expertise to internal and external customers
Safety expert for product

Maintain knowledge of product, product environment, and recent literature
Maintain PV expertise, and understanding of international safety regulations and guidelines
Lead cross functional Safety Management Teams (SMTs) and GPE internal -Safety Analysis Teams (SATs)
Communicate with and represent PV position within project/product teams, with external partners, key opinion leaders, and Health Authorities, and during internal and external negotiations
Provide strategic and proactive safety input into development plans
Support due diligence activities and pharmacovigilance agreements

Signal Detection And Assessment

Responsible for signal detection and analysis
Collaborate with Center of Excellence for Signal Detection and Data Mining and -Safety Epidemiology group
Identify and implement proactive safety analysis strategies to further define the safety profile.
Lead aggregate safety data review activities and coordinate safety surveillance activities

Risk Assessment/Risk Management/ Benefit-Risk Assessment

Provide proactive risk assessment
Co-lead benefit-risk assessment with other relevant functions
Develop risk management strategies and plans and monitor effectiveness
Collaborate with Center of Excellence for Risk Management and Safety Epidemiology



Submission Activities

Represent safety position in cross functional submission teams
Ensure generation, consistency, and quality of safety sections in submission documents
Write responses or contributions to health authorities
Support preparation and conduct of Advisory Committee meetings



Report Writing

Document, coordinate, review and validate Periodic reports, e.g.: RMP update, IND Annual Report, Annual Safety Report/Development Safety Update Report, -Periodic Safety Update Report
Serve as the medical safety expert to the GPE Periodic Reports group for assigned projects and products.



Major Challenges & Problems

Providing product safety leadership within project teams having multiple and at times competing priorities and timelines
Championing the GPE position within a large and complex organization
Determining the appropriate risk minimization and mitigation measures in light of -B/R assessment in coordination with different parties
Addressing internal and external customer queries, including those from Health Authorities, in a rapid and effective manner and within appropriate timelines. The above challenges are effectively managed through strong leadership and communication skills paired with an assertive yet collaborative approach, a high level of medical and scientific



Key Internal/External Relationships

Internal: other GPE Units, R&D Units and Business Divisions, Scientific Core Platforms, Medical and Regulatory Affairs, Franchise(s), Legal Department, Communication, Affiliates (APH)

External: Regulatory/Competent Authorities, Ethics Committee, Investigators, Data Monitoring Committees, partners, CROs



Decision Making Authority

Identify potential signals/issues of pharmacovigilance and evaluate product safety
Recommend/discuss and coordinate appropriate course of action
Ask project/product team for necessary amendments, labelling modifications/variations
Lead SMT and SAT
Approve safety regulatory and clinical documents including submission, transversal and primary GPE documents as per SOP Information/Decisions to be referred to hierarchy:
Transmission of any decision with impact on Study Conduct (e.g. Clinical Hold)
Transmission of any safety concerns for which GSO is informed (e.g. Health -Authority restriction/decision)

Basic Qualifications

M.D. Degree

Minimum 10 years total experience in international pharmacovigilance



Preferred Qualifications

Board Certified/Board eligible, or equivalent

Excellent clinical judgment

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

Experience in MS

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