GLOBAL PROGRAM SAFETY LEAD
Descripción de la oferta de empleo
Responsible for the company’s drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs.
Participates in the resolution of any legal liability and complying with governmental regulations.
Provides and contributes trending and safety signal detection and risk management assessment for the products’ life cycle.
Provides safety support to the clinical development teams.
About the Role Primary Location.
Basel, Switzerland Alternate Location(s).
Barcelona, Spain Working model.
Both locations have a hybrid working model (12 days per month in the office) About this role.
Our Senior Global Program Safety Lead excels as a scientific safety leader within the Oncology Medical Safety organization.
Join us and you will make a significant impact on patients' lives and contribute to Novartis' overall success through robust safety evaluation expertise and medical innovation.
Key Responsibilities.
Safety Input and Team Participation.
Provide expert safety input to the clinical development program for assigned projects/products and actively participate in the Global Program Team (GPT), Global Clinical Team (GCT), and Clinical Trial Team (CTT).
Responsible for managing safety issues from the formation of the GPT through Life Cycle Management.
Signal Detection and Safety Management.
Oversee overall signal detection, monitoring, evaluation, interpretation, and appropriate management of safety information, based on data from all relevant line functions, post-marketing data, and other sources.
Documentation and Record Keeping.
Ensure proper documentation, tracking, and record-keeping of medical safety activities for assigned compounds.
Regulatory and Professional Inquiries.
Respond to inquiries from regulatory authorities or healthcare professionals regarding safety issues.
Safety Strategy Preparation.
Lead the preparation of the safety strategy for health authority responses and collaborate with other project team members.
Departmental and Functional Goals.
Contribute to and often lead the development of departmental and functional/business unit goals and objectives.
Marketing Samples Distribution.
Manage the distribution of marketing samples, where applicable.
Key performance indicators.
Timeliness and quality of safety analyses, interpretations, and presentation Compliance with internal and external regulations & procedures Compliance, consistency and quality of safety deliverables Role Requirements.
Medical Degree is required 10+ years of experience in Big Pharma 3 to 5 years Oncology experience.
Skills.
Clinical Research.
Clinical Trials.
Functional Teams.
Leadership.
Medical Strategy.
Process Safety Management.
Regulatory Compliance.
Risk Management.
Safety Science.
Languages.
Fluent English (both spoken and written) is mandatory.
Additional languages are an advantage.
Detalles de la oferta
- Sin especificar
- En toda España
- Sin especificar - Sin especificar
- 06/12/2024
- 06/03/2025
Able to work on a b2b agreement but with permanent conditions... collaborate with other teams and departments to gather and/or share information relating to team activities... experience in backend development with php a solid understanding of scrum and agile methodologies and be able to guide and mentor......
Madrid lifestyle program (for tefl holders) with spanish: 1... a ten month, 20 hrs/wk instituto cervantes accredited spanish program (your student visa is based on this)... only one year university and instituto cervantes accredited spanish language program students can work in spain and this is the......
Madrid lifestyle program (for tefl holders) with spanish: 1... a ten month, 20 hrs/wk instituto cervantes accredited spanish program (your student visa is based on this)... only one year university and instituto cervantes accredited spanish language program students can work in spain and this is the......
Madrid lifestyle program (for tefl holders) with spanish: 1... a ten month, 20 hrs/wk instituto cervantes accredited spanish program (your student visa is based on this)... only one year university and instituto cervantes accredited spanish language program students can work in spain and this is the......
Have experience or strong interest in the fields of peace education or global education in language teaching... pdf video: find out why you should participate in the get program in the words of former teachers: https://vimeo... peace boat's 119th global voyage will visit 17 ports in 13 different countries......
Sign up now and contribute to the advancement of speech recognition technology! if you have any questions, contact us at: *****@***** otros datos del puesto***dataforce by transperfect is part of the transperfect family of companies, the world’s largest provider of language and technology solutions for......
Únete a nuestro equipo en este increíble viaje de transformacióna través de la comunicación global estamos buscando representante comercial con ubicacion en europa y experiencia en ventas para ayudarnos a lograr nuestros objetivos de expansión global... experiencia en la identificación de clientes potenciales......
Somos una empresa global y transparente, con 30 años de trayectoria, cotizamos en nasdaq, lo que subraya nuestra seriedad y compromiso con la excelencia... te ofrecemos la oportunidad de unirte a una red global que no solo potenciará tu crecimiento personal y profesional, sino que también te permitirá......
• projects implementation working with all departments involved and be the local coordination of global initiatives• participate in the creation of commercial kpis • results analysis according kpi's definedrequisits• educational background in business administration or industrial engineering......
Roustabouts / roughnecks, welders / mechanics, rig operators / drillers, engineers (petroleum and mechanical) health and safety officer, superintendent smp, smp supervisor, document controller clerk, community superintendent, training / hrd superintendent; smp engineer, mine engineer, mine surveyor,......
