Job title: Global Safety Officer M/F

Company: Sanofi

Job description: ABOUT THE OPPORTUNITY – CONTEXT Join Sanofi as a Global Safety Officer (GSO). In this critical role, you will provide medical input on the safety evaluation of drugs under development and established drugs. ABOUT GROWING WITH US – KEY ACCOUNTABILI

ABOUT THE OPPORTUNITY – CONTEXT Join Sanofi as a Global Safety Officer (GSO). In this critical role, you will provide medical input on the safety evaluation of drugs under development and established drugs. ABOUT GROWING WITH US – KEY ACCOUNTABILITIES In this role you will Internal & External Safety Expert Provide PV and risk management expertise to internal and external customers Be the 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 Be 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 ABOUT YOU – PROFILE Qualifications/Education & Work Experience M.D. Degree, Board Certified/Board eligible, or equivalent, is preferred Minimum 3 years of 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 of international PV experience Experience in the immunology and inflammation therapeutic area strongly preferred Competencies Excellent clinical judgment Capability to synthe 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) INSPIRE YOUR JOURNEY, WHAT SANOFI CAN OFFER YOU An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team An individual and well-structured introduction and training when you onboard You can create your own career path within Sanofi. Your professional and personal development will be supported purposefully As a globally successful and constantly growing company, Sanofi provides international career paths as well This is our Sanofi. Discover yours. At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

Expected salary:

Location: Mumbai, Maharashtra

Job date: Tue, 17 May 2022 22:38:33 GMT

Apply for the job now!