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A Range of Possibilities

Global Safety Officer

date posted 10/26/2022
contract type Full time
job id R2640822
location Reading;

Major Duties and Responsibilities

Internal & External Safety Expert with a clear and contemporary understand of Benefit Risk:

  • Provide PV and risk management expertise to internal and external customers

  • Safety expert for product must have an attitude of continuous learning and understand the product attributes and science

  • Maintain knowledge of product, product environment, and recent literature

  • Maintain expertise in drug safety and PV, and understanding of international safety regulations and guidelines

  • Lead cross functional Safety Management Teams (SMTs) and GPV 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

Impact:

  • Ongoing assessment of the safety status of the product

  • Review, preparation, contribution and/or approval of clinical development documents including clinical development plans, SAPs, study protocols, investigator brochures, data monitoring plans, study reports, integrated summary of safety, summary of clinical safety, and labeling 

  • Review, preparation, and/or contribution to questions/requests from health authorities, ethics committees/ IRBs, external partners

  • Management of product safety alerts

  • Ensuring the GPV’s position is well articulated to and understood by its internal and external stakeholders

  • Continued visibility and Establishment of the credibility of GSO role/function and consequently GPV

  • Signal Detection and Assessment:

  • Responsible for overseeing from multiple contributors signal detection and analysis

  • Collaborate with Center of Excellence for Signal Detection and Data Mining and the Safety Epidemiology group

  • Identify and implement proactive safety analysis strategies to further define the safety as well as Benefit Risk profile.

  • Lead the review of aggregate safety data and related activities as well as coordinate safety surveillance activities

Qualifications

Knowledge and Skills

  • Excellent clinical judgment

  • Articulate and clearly understood in telephone communications

  • Capability to synthesize and critically analyze data from multiple sources supported by sound clinical reasoning

  • 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 and with a good sense of Prioritization of business critical deliverables

  • Demonstrates leadership within cross-functional team environment

  • Excellent teamwork and interpersonal skills are required

  • Fluency in English (written and spoken).

Formal Education And Experience Required

  • M.D. Degree or equivalent. (i.e. MB.BS or DO)

  • MD, Board Certified/Board eligible, or international equivalent, is preferred

  • M.D., minimum 2-3 years' of unsupervised clinical practice (not residency) and a minimum of 3 years in total experience in international or large market  pharmacovigilance, or at least 4 years of clinical development  experience in phase 1b to 3b.

  • 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.

At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

Fully vaccinated, according to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.  

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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.

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