Global Safety Officer

26 May 2024

Vacancy expired!

Major Duties & ResponsibilitiesInternal & 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

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 from health authorities, ethics committees, IRBs, external partners

Management of product safety alerts

Ensuring the GPE position is well articulated to and understood by its internal and external customers

Establishment of credibility of GSO function and of GPE

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

Impact

Signal detection and analysis

Development of safety action plans and implementation, as appropriate

Enable effective development of product safety

Enable appropriate risk management

Enable up-to-date risk communication (e.g. labeling)

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

Impact

Optimization of the product benefit risk profile

Development of REMS, Risk Management and Development Risk Management plans

Identification and implementation of risk mitigation or other corrective actions as necessary

Regulatory compliance

Monitoring of risk mitigation tool effectiveness and adjustment of strategy, as needed

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

Impact

Review, data analysis, preparation and/or contribution, and/or update of safety sections of relevant documents:

For products under clinical development: Clinical Development Plan, study protocol, Statistical Analysis Plan, data monitoring plan, investigator brochure, Informed Consent Form, study report, Integrated Summary of Safety, Summary of Clinical Safety, risk management plan, label, periodic reports

For marketed products: Response to health authority question/request for information, Core Safety Information updates, periodic reports

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.

Impact

Regulatory Compliance.

QualificationsKnowledge and 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 And Experience Required

M.D. Degree or equivalent.

For MD, Board Certified/Board eligible, or equivalent, is preferred

For M.D., minimum 3 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.

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.#GD-SA#LI-SAAt 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.

Full-time
  • ID: #50005272
  • State: Arizona Phoenix 85001 Phoenix USA
  • City: Phoenix
  • Salary: USD TBD TBD
  • Showed: 2023-05-26
  • Deadline: 2023-07-26
  • Category: Et cetera