Vigilance Process Expert

Job title:

Vigilance Process Expert

Company:

Novartis

Job description

Job Description Summary You will be responsible for the End to end management of assigned pharmaco and devices vigilance processes across Novartis and leadership of PS&PV projects to ensure compliance to global regulatory requirements with maximum efficiency.Job DescriptionMajor activitiesDrive continuous process improvement by alignment of relevant stakeholders globally and locally, assessing opportunities for streamlining and automation.Lead assigned PS&PV projects and support higher complexity/criticality projects led by (Senior) Vigilance Process Managers, including IT projects/systems, in alignment with the company and department strategy.Act as process owner / deputy process owner for assigned vigilance processes:

• Support active surveillance and analysis of emerging regulations, perform impact assessments, and drive process changes to ensure ongoing compliance to global regulatory requirements.
• Author and maintain the assigned processes and the associated procedural documents.
• Mentor and train new starters in PS&PV and participating in the creation and maintenance of training material and communications for Novartis and third-party associates.
• Act as Subject Matter Expert / consultant to PS&PV associates, Country Organizations and other Global Line Functions on regulatory requirements and assigned business process.
• Own and maintain relevant PSMF sections and annexes.
• Maintain the content of Business Continuity Plans for all respective processes, including IT applications for Key Business Processes.

Role requirementsPhD, PharmD, MSc degree or Life sciences degree or equivalentMinimum 2-4 years of experience in the pharmaceutical industry, particularly pharmacovigilance. Experience in medical device vigilance desirable.SkillsExperience of leading working groups.Procedural document writing experience.Good analytical skills / proven ability to work with data.Strong presentation and communication skills, and ability to operate effectively in an international environment and across functions.Strong organizational skillsAbility to mentor and coachQuality focusLanguagesFluency in English. Knowledge of other languages desirable.Skills Desired Databases, Employee Training, Filing Documents, Pharmacovigilance, Reporting, Safety Science

Expected salary

Location

Barcelona

Job date

Fri, 10 Jan 2025 07:14:51 GMT

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