Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy. Headquartered in Denmark, Novo Nordisk employs approximately 33,300 employees in 75 countries, and markets its products in more than 190 countries Novo Nordisk’s B shares are listed on NASDAQ OMX Copenhagen (Novo-B).
Post : Safety Operations Specialist in Global Safety Team
Job Description
As a Safety Operation Specialist, you will act as process expert for C2.01 in handling adverse events and other safety information, you would also be representing safety operations in the GS Regulatory Surveillance forum. And you will be key link to global safety affiliates and responsible for escalating local safety reporting issues impacting the CVP area to GS management, and act as the primary representative for Safety Operations in audits and inspections (PV, GCP & GMP) also you would act as deviation owner & CR owner within area of expertise and you need to ensure fulfilment of global regulatory requirements to the collection, evaluation and reporting of safety information on development & marketed medicinal products & devices, and establish new or improved methods of working within field of expertise by ensuring and encouraging share better practice and consistency of safety deliverables and ensure development and maintenance of functional procedures and operational processes related to reporting of safety data to ensure regulatory compliance in line with GS strategic framework. And ensure consistency across global safety hubs with regards to processes, priorities, quality and timeliness.
Ensure cross-organisational communication and cooperation with regards to safety information of high complexity, critical to the area. And you would be communicating and interacting with professional authority to provide pharmacovigilance knowledge and quality understanding for critical safety deliverables to global stakeholders. Communicating with health Authorities in relation to inspections requires professional and scientific insight, self-dependence, and professional authority, competence in decision making, as well as flexibility and excellent co-operation in an international environment, hence you will be applying cultural awareness and creating an inclusive atmosphere in all interactions/communications with internal and external stakeholders/customers globally, also assess potential impact on patient safety in connection with process deviations and new regulatory requirements. And you would be negotiating agreements with external partners concerning safety information.
Candidate Profile
• MBBS, PhD, BDS, M. Pharm, MTech
• Minimum of 12 years of relevant working experience within PV
• Extensive knowledge of pharmacovigilance principles and businesses processes required for the establishment of efficient handling of safety information
• Experience in managing a field of expertise that requires highly specialized knowledge of strategic importance to the area
• Experience in providing training and support in a professional context
• In depth Novo Nordisk organizational and/or pharmaceutical company understanding
• Extensive experience in studying scientific regulations/guidelines
• Extensive knowledge and understanding of GxP requirements
• Experience working with business process improvements
• Experience with working in international and diverse professional groups
• Fluency in English, both written and spoke
• High personal integrity, authority, impact and maturity
• Highly innovative, challenging the existing methods/ways
• Strategic and quality mind-set, systematic and analytic
• Exercising independency in decision making and handling of specialist tasks
• Ability and willingness to quickly adjust to changes in a continuously developing environment
• Highly motivated and visionary within the field of expertise
• Excellent communication skills; ability to reach agreement through flexibility and compromise or convincing others of new concepts, practices and ideas
• Excellent at planning and coordinating multiple simultaneously activities
• Strong sense of structure and focus on detail and quality control
• Strong ability to work against deadlines
• Ability to foresee the impact changes to system/processes will have on interlinked systems and processes
Additional Information
Qualification : MBBS, Ph.D, BDS, M.Pharm, M.Tech
Experience : 12 years
Location : Bangalore, Karnataka
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Safety Operations
End Date : 18th April, 2020
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