Global Safety Officer

Global Safety Officer

Sanofi

Paris, Amsterdam, Frankfurt or Budapest

KEY ACCOUNTABILITIES

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);
• Communicate with and represent PV analyses and PV position within project/product teams, in safety governance and benefit-risk governance activities and committees (e.g. Safety Management Committee, Benefit-Risk Assessment Committee), 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 & 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 Epidemiology/Benefit-Risk groups.

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’ questions;
• Support preparation and conduct of Advisory Committee meetings.

Report Writing

• Document, contribute to, coordinate, review and/or 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 GPV Periodic Reports group for assigned projects and products.

PROFILE

Knowledge & Skills

• 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;
• Excellent teamwork and interpersonal skills are required;
• Fluent in English (written and spoken).

Formal Education & Experience Required

• M.D. Degree, or degree in pharmacy, biological sciences or related disciplines;
• Non-MD GSO can only be assigned to the following product areas: generics, consumer healthcare, vaccines and “mature products”, where mature products are defined as those no longer under patent or other data exclusivity protection AND where there is no on-going significant investment in development or marketing;
• For MD, Board Certified/Board eligible, or equivalent, is preferred; For other degrees, advanced post-graduate qualifications e.g. Master or PhD are preferred;
• For M.D., minimum 3 years' and for other degrees, minimum 5 years' total experience in international pharmacovigilance, or equivalent relevant industry experience (e.g. clinical development) with relevant clinical experience considered. Exceptionally, candidates may be considered if they have proven excellence in a similar prior position, even if they have less than 3 years international PV experience.

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